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1.
Am J Med Genet A ; 194(4): e63488, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38062645

ABSTRACT

Marshall syndrome is an extremely rare genetic disorder usually diagnosed in infancy with a prevalence of <1 in 1 million. Based on the literature reviewed, this is the first case report to provide a longitudinal history of a child with Marshall syndrome (from birth to age 12.5 years). This longitudinal case report arose in part from desires of this child's parents to share the story of their early fears at her initial diagnosis and compare those to how well she has turned out.


Subject(s)
Cataract , Collagen Type XI/deficiency , Craniofacial Abnormalities , Hearing Loss, Sensorineural , Osteochondrodysplasias , Humans , Child , Female , Mutation , Osteochondrodysplasias/diagnosis , Osteochondrodysplasias/genetics , Craniofacial Abnormalities/genetics , Hearing Loss, Sensorineural/genetics , Syndrome
2.
Rural Remote Health ; 23(4): 8413, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38061345

ABSTRACT

INTRODUCTION: The purpose of the study was to identify barriers and facilitators of colorectal cancer (CRC) screening use among agricultural operators in Nebraska, US. METHODS: The concept mapping approach was used to engage participants and enhance the generation of ideas and opinions regarding CRC screening. Two focus groups (seven women and seven men) were conducted. RESULTS: Among women, the cost domain was most agreed upon as important, followed by experiencing symptoms, awareness, and family. Among men, the important concepts related to CRC screening were family and friend support, feeling too young to get CRC, family or personal history of CRC, and lack of awareness of the need to be screened. Some gender differences regarding barriers were observed, such as women were more concerned about the cost of screening while men were far more concerned about the embarrassment associated with CRC screening. CONCLUSION: These findings will be crucial to developing educational materials to increase knowledge of risk factors for CRC and of CRC screening in the agricultural population.


Subject(s)
Colorectal Neoplasms , Patient Acceptance of Health Care , Male , Humans , Female , Pilot Projects , Health Knowledge, Attitudes, Practice , Focus Groups , Colorectal Neoplasms/diagnosis , Colorectal Neoplasms/prevention & control , Early Detection of Cancer , Mass Screening
3.
Prev Med ; 149: 106601, 2021 08.
Article in English | MEDLINE | ID: mdl-33971211

ABSTRACT

Children are a priority population for skin cancer prevention as excessive sun exposure in childhood increases the risk of melanoma in adulthood. The complexity of sun protective behaviors has posed measurement challenges for trials testing intervention efficacy. The current study evaluated a sun safety intervention for schoolchildren using latent transition analysis (LTA) to examine patterns of sun protection behaviors over time. A three-armed randomized controlled trial was conducted between 2012 and 2016 with two intervention groups (N = 3368) and an observation-only control group (N = 342) among 4th and 5th graders from 24 public schools in Los Angeles County. Both interventions conditions were grouped and compared to controls. Five self-reported sun protective behaviors were measured at baseline and three-month follow-up: use of sunscreen, long sleeves, long pants, hats, and shade seeking. Participants comprised 3710 schoolchildren, mean age 9 years, 47% female and 69% Latino. At baseline, four patterns of sun protection behaviors were found: children who engaged in 1) all sun protective behaviors; 2) few protective behaviors; 3) protective clothing and shade only; and 4) hats only. Children in the control group were likely to remain in their baseline status or transition to a less protective status at three-month follow-up. By contrast, 30% of children in the intervention group transitioned to a more protective status at follow-up. In this RCT of a sun safety intervention, children in the intervention transitioned to more protective behaviors compared to controls. Using LTA enriches understanding of intervention efficacy by modeling the complexity of sun protection behaviors over time. TRIAL REGISTRATION: School-based Randomized Trial of SunSmart Interventions, ClinicalTrials.gov Identifier: NCT04176237 https://clinicaltrials.gov/ct2/show/NCT04176237?cond=School-based+Randomized+Trial+of+SunSmart+Interventions&draw=2&rank=1.


Subject(s)
Melanoma , Skin Neoplasms , Sunburn , Adult , Child , Female , Health Behavior , Humans , Male , Protective Clothing , Skin Neoplasms/prevention & control , Sunburn/prevention & control , Sunscreening Agents/therapeutic use
4.
Dev Psychopathol ; 33(4): 1156-1169, 2021 10.
Article in English | MEDLINE | ID: mdl-32672147

ABSTRACT

Growing evidence suggests that emotion socialization may be disrupted by maternal depression. However, little is known about emotion-related parenting by mothers with bipolar disorder or whether affective modeling in early childhood is linked to young adults' recollections of emotion socialization practices. The current study investigates emotion socialization by mothers with histories of major depression, bipolar disorder, or no mood disorder. Affective modeling was coded from parent-child interactions in early childhood and maternal responses to negative emotions were recollected by young adult offspring (n = 131, 59.5% female, M age = 22.16, SD = 2.58). Multilevel models revealed that maternal bipolar disorder was associated with more neglecting, punishing, and magnifying responses to children's emotions, whereas maternal major depression was associated with more magnifying responses; links between maternal diagnosis and magnifying responses were robust to covariates. Young adult recollections of maternal responses to emotion were predicted by affective modeling in early childhood, providing preliminary validity evidence for the Emotions as a Child Scale. Findings provide novel evidence that major depression and bipolar disorder are associated with altered emotion socialization and that maternal affective modeling in early childhood prospectively predicts young adults' recollections of emotion socialization in families with and without mood disorder.


Subject(s)
Mothers , Socialization , Adult , Child, Preschool , Emotions , Female , Humans , Male , Mood Disorders , Parenting , Young Adult
5.
J Drugs Dermatol ; 20(3): 252-258, 2021 03 01.
Article in English | MEDLINE | ID: mdl-33683083

ABSTRACT

BACKGROUND: Psoriasis is a chronic, inflammatory disease that may differ in prevalence and clinical presentation among patients from various racial and ethnic groups. Two phase 3 studies demonstrated efficacy and safety of halobetasol propionate (HP) 0.01% lotion in the treatment of moderate-to-severe plaque psoriasis (NCT02514577, NCT02515097). These post hoc analyses evaluated HP 0.01% lotion in Hispanic participants. METHODS: Participants were randomized (2:1) to receive once-daily HP or vehicle lotion for 8 weeks, with a 4-week posttreatment follow-up. Post hoc efficacy assessments in Hispanic participants (HP, n=76; vehicle, n=43) included treatment success (≥2­grade improvement in Investigator’s Global Assessment and score of ‘clear’ or ‘almost clear’), psoriasis signs, and affected body surface area (BSA). Treatment-emergent adverse events (TEAEs) were evaluated. RESULTS: At week 8, 38.8% of participants achieved treatment success with HP versus 10.3% on vehicle (P=0.001). HP­treated participants achieved greater improvements in psoriasis signs, compared with vehicle (P<0.01 all). HP group had a greater reduction in affected BSA versus vehicle (P=0.001). Treatment-related TEAEs with HP were application site infection and dermatitis (n=1 each). CONCLUSIONS: Once-daily HP 0.01% lotion was associated with significant reductions in disease severity in Hispanic participants with moderate-to-severe psoriasis, with good tolerability and safety over 8 weeks. J Drugs Dermatol. 2021;20(3):252-258. doi:10.36849/JDD.5698.


Subject(s)
Clobetasol/analogs & derivatives , Dermatitis, Contact/epidemiology , Dermatologic Agents/administration & dosage , Psoriasis/drug therapy , Vasoconstrictor Agents/administration & dosage , Administration, Cutaneous , Adult , Clobetasol/administration & dosage , Clobetasol/adverse effects , Dermatitis, Contact/etiology , Dermatologic Agents/adverse effects , Double-Blind Method , Drug Administration Schedule , Female , Hispanic or Latino , Humans , Male , Middle Aged , Psoriasis/diagnosis , Severity of Illness Index , Treatment Outcome , Vasoconstrictor Agents/adverse effects
6.
Spinal Cord ; 59(6): 700-704, 2021 Jun.
Article in English | MEDLINE | ID: mdl-33828245

ABSTRACT

Aging women face increased risks of both breast cancer and spinal cord injury (SCI). Unique treatment challenges for this population warrant consideration. Despite advances in breast cancer treatments, significant adverse health outcomes continue to occur. Cancer treatments can be detrimental to the quality of life of able-bodied women, but more so for women living with pre-existing SCI. The goal of this Perspective Paper is to inform rehabilitation professionals about the needs of women with SCI treated for breast cancer. Specific objectives were: (1) give an overview of breast cancer treatment-related adverse outcomes that need special attention in women with SCI; and (2) inspire researchers to study the consequences of breast cancer-related health conditions in women with SCI. We identified SCI-specific considerations for undergoing breast cancer surgery, chemotherapy, radiation and endocrine therapy. This paper attempts to raise awareness regarding these issues due to the lack of research attention they have received.


Subject(s)
Breast Neoplasms , Spinal Cord Injuries , Breast Neoplasms/complications , Breast Neoplasms/epidemiology , Breast Neoplasms/therapy , Female , Humans , Outcome Assessment, Health Care , Quality of Life , Spinal Cord Injuries/complications , Spinal Cord Injuries/epidemiology , Spinal Cord Injuries/therapy
7.
Oncologist ; 25(10): e1583-e1585, 2020 10.
Article in English | MEDLINE | ID: mdl-32525604

ABSTRACT

The aim of this case report is to inform clinicians about radiation-induced brachial plexopathy, a rare complication that often presents well after treatment with inconsistent symptoms and manifestations. It is often a diagnosis of exclusion when a neoplastic or other cause cannot be identified. Electrodiagnostic testing is particularly useful. Here, the results of a standardized grip and pinch strength assessment and dexterity test are presented in a woman whose symptoms first appeared 20 years after completing treatments for stage IIIA breast cancer.


Subject(s)
Brachial Plexus Neuropathies , Breast Neoplasms , Radiation Injuries , Brachial Plexus Neuropathies/diagnosis , Brachial Plexus Neuropathies/etiology , Breast Neoplasms/complications , Breast Neoplasms/radiotherapy , Female , Humans , Radiation Injuries/diagnosis , Radiation Injuries/etiology
8.
J Drugs Dermatol ; 19(3): 272-279, 2020 03 01.
Article in English | MEDLINE | ID: mdl-32549090

ABSTRACT

Background: As current tazarotene formulations indicated for acne (0.1%) can cause irritation, a new tazarotene 0.045% lotion formu-lation was developed using polymeric emulsion technology. The objective was to assess efficacy, safety, and tolerability of tazarotene 0.045% lotion in patients with moderate-to-severe acne in a pooled analysis of data from two identical phase 3, double-blind, random-ized, vehicle-controlled 12-week clinical studies. Methods: Patients aged ≥9 years with moderate-to-severe acne were randomized (1:1) to tazarotene 0.045% lotion or vehicle lotion applied once daily. Inflammatory and noninflammatory lesion counts and Evaluator's Global Severity Score (EGSS) were assessed. Treatment success was defined as a ≥2-grade improvement in EGSS and a score of 'clear'/'almost clear'. Adverse events (AEs) and cutaneous safety and tolerability were also assessed. Results: In total, 1614 patients (mean age: 20.5 years) were randomized to tazarotene 0.045% lotion (n=799) or vehicle (n=815). At week 12, tazarotene 0.045% lotion demonstrated statistically significant superiority versus vehicle in reducing inflammatory and non-inflammatory lesion counts (least-squares mean percent changes from baseline: inflammatory, -57.9% vs -47.8% [P<0.001]; noninflam-matory, -56.0% vs -42.0% [P<0.001]). Treatment success at week 12 was also greater with tazarotene 0.045% lotion versus vehicle (30.4% vs 17.9%; P<0.001). The most frequent treatment-emergent AEs related to tazarotene treatment were application site pain (5.3%), dryness (3.6%), and exfoliation (2.1%). Conclusions: The new tazarotene 0.045% lotion formulated with polymeric emulsion technology demonstrated statistically signifi-cantly superior efficacy versus vehicle and was well tolerated in pediatric and adult patients with moderate-to-severe acne in this pooled analysis of 2 vehicle-controlled phase 3 studies. J Drugs Dermatol. 2020;19(3):272-279. doi:10.36849/JDD.2020.4869.


Subject(s)
Acne Vulgaris/drug therapy , Keratolytic Agents/administration & dosage , Nicotinic Acids/administration & dosage , Pain/epidemiology , Skin Cream/administration & dosage , Acne Vulgaris/diagnosis , Adolescent , Adult , Aged , Child , Clinical Trials, Phase III as Topic , Double-Blind Method , Emulsions/administration & dosage , Emulsions/adverse effects , Emulsions/chemistry , Female , Humans , Keratolytic Agents/adverse effects , Keratolytic Agents/chemistry , Male , Middle Aged , Nicotinic Acids/adverse effects , Pain/chemically induced , Polymers/chemistry , Quality of Life , Randomized Controlled Trials as Topic , Severity of Illness Index , Skin Cream/adverse effects , Skin Cream/chemistry , Treatment Outcome , Young Adult
9.
J Drugs Dermatol ; 19(7): 727-734, 2020 Jul 01.
Article in English | MEDLINE | ID: mdl-32726105

ABSTRACT

Background: Acne vulgaris and inflammation-associated sequelae are highly prevalent in black and Hispanic populations. In a phase 2 study, a novel polymeric emulsion formulation of tazarotene 0.045% lotion had relatively fewer adverse events than tazarotene 0.1% cream, but with comparable efficacy. The objective was to evaluate tazarotene 0.045% lotion by race and ethnicity in the pivotal trials. Methods: In two phase 3, double-blind, 12-week studies (NCT03168334; NCT03168321), participants with moderate-to-severe acne were randomized 1:1 to tazarotene 0.045% lotion or vehicle lotion (N=1,614). This pooled, post hoc analysis included subsets of participants that self-identified as white (n=1191) or black (n=262) and Hispanic (n=352) or non-Hispanic (n=1262). Coprimary endpoints were inflammatory/noninflammatory lesion counts and treatment success (defined as at least a 2-grade reduction from baseline in Evaluator's Global Severity Score and a score of 'clear' or 'almost clear'). Treatment-emergent adverse events (TEAEs) and cutaneous safety and tolerability were evaluated. Results: At week 12, tazarotene 0.045% lotion led to significantly greater percent reductions in inflammatory and noninflammatory lesions compared with vehicle in white, Hispanic, and non-Hispanic participants (P<0.05, all). Black participants had significantly greater reductions in noninflammatory lesions following treatment with tazarotene 0.045% versus vehicle (P<0.05). Treatment success rates in all subpopulations were higher with tazarotene 0.045% lotion (29.4-34.1%) versus vehicle (16.4-23.1%). TEAE rates were similar across tazarotene-treated groups and most were mild-to-moderate in severity. The incidence of hyperpigmentation decreased in black tazarotene-treated participants from baseline to week 12. Conclusions: Tazarotene 0.045% lotion demonstrated efficacy and was well tolerated across racial and ethnic subpopulations in this pooled analysis. J Drugs Dermatol. 2020;19(7) doi:10.36849/JDD.2020.5125.


Subject(s)
Acne Vulgaris/drug therapy , Keratolytic Agents/therapeutic use , Nicotinic Acids/therapeutic use , Acne Vulgaris/ethnology , Acne Vulgaris/pathology , Administration, Cutaneous , Child , Double-Blind Method , Ethnicity , Female , Humans , Keratolytic Agents/administration & dosage , Male , Nicotinic Acids/administration & dosage , Severity of Illness Index , Skin Cream , Treatment Outcome
10.
Eur J Pediatr ; 178(4): 581-585, 2019 Apr.
Article in English | MEDLINE | ID: mdl-30635706

ABSTRACT

This short communication provides an update on childhood psychogenic movement disorders (PMD), focusing on descriptive studies and case reports from 2008 to 2018. Known also as functional movement/motor disorders, PMD diagnoses are relatively common in adults but less so in children. In group studies over the past decade, sample prevalence of childhood PMD ranged from 2.8 to 23.1%, with a higher percentage of girls in most studies (consistent with adult PMD literature). Common types of PMD included tremor (32.4%), dystonia (29.5%), and myoclonus (24.3%). Precipitating events for PMD onset included H1N1 influenza vaccinations, family/child stressors, anxiety/depression in the child or parent, panic attacks, behavior disorders, injury or accident, sexual abuse of the child or family member, death of a close relative, parental discord, domestic violence, school-related problems, medical illness/surgery, sleep disturbance, and participation in competitive sport or dance. The most frequently mentioned treatments were cognitive behavioral therapy, psychotherapy, relaxation techniques, and physiotherapy.Conclusion: Although additional cases of childhood PMD have been published over the past decade, little new information has appeared. There is still no "diagnostic gold standard," making an accurate estimate of prevalence virtually impossible and contributing to confusion among pediatricians when trying to identify children with PMD. What is Known: • Psychogenic movement disorders (PMD) occur in children as well as adults. • The most common types of childhood PMD are tremor, dystonia, and myoclonus. What is New: • The most common childhood PMD treatments were cognitive behavioral therapy, psychotherapy, physiotherapy, and relaxation techniques (2008-2018). • Due to lack of a standardized definition for PMD, confusion exists as to which movement disorders to include. With the inability to reliably diagnose PMD and the ambiguity as to which movement disorders it comprises, it is difficult to determine the most effective treatments.


Subject(s)
Movement Disorders , Adolescent , Child , Female , Humans , Male , Movement Disorders/diagnosis , Movement Disorders/epidemiology , Movement Disorders/therapy
11.
J Drugs Dermatol ; 18(2): 178-188, 2019 Feb 01.
Article in English | MEDLINE | ID: mdl-30811141

ABSTRACT

Background: Acne vulgaris (acne) is a common dermatological condition typically associated with adolescents, affecting about 85% of young people. However, it is also prevalent and persistent into adulthood, particularly in females. The efficacy of tretinoin in acne is well documented with large pivotal studies. The first lotion formulation of tretinoin was developed to provide an important alternative option to treat acne patients who may be sensitive to the irritant effects of other tretinoin formulations. Objective: To determine whether efficacy and safety of tretinoin 0.05% lotion was similar in adolescent (<18 years) and adult (>=18 years) women with moderate-to-severe acne. Methods: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies in moderate or severe acne. Female subjects (aged 9 to 58 years, N=909) randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory and noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator's Global Severity Score [EGSS] and clear/almost clear). Safety, adverse events (AEs), and cutaneous tolerability were evaluated throughout. Results: At week 12, mean percent reduction in inflammatory and noninflammatory lesion counts in female subjects were 56.9% and 51.7%, respectively, compared with 47.1% and 34.9% with vehicle (P=<0.001). Similar results were seen in adult and adolescent females in terms of reduction in inflammatory lesion counts with tretinoin 0.05% lotion; reduction in noninflammatory lesions was significantly greater in adult females (P=0.002). Treatment success was achieved by 23.6% of female subjects by week 12, compared with 13.5% on vehicle (P<0.001). Although treatment success was somewhat greater in adult females (24.6% versus 21.6%), the difference was not significant. The majority of AEs were mild and transient. There were five serious AEs (SAEs) reported (4/1, adult/adolescent, respectively). The most frequently reported treatment related AEs with tretinoin 0.05% lotion were application site pain (3.0%/5.7%), and application site dryness (4.9%/6.4%). Local cutaneous safety and tolerability assessments were generally mild-to-moderate and improved by week 12. Slight increases in mean scores were observed for scaling, burning and stinging within the first four weeks and appeared to be transient. Conclusions: Tretinoin 0.05% lotion was significantly more effective than its vehicle in achieving treatment success and reducing inflammatory and noninflammatory lesions in female acne. Noninflammatory lesion count reduction was significantly greater in adult females compared with adolescent females. The new lotion formulation was well-tolerated. J Drugs Dermatol. 2019;18(2):178-188.


Subject(s)
Acne Vulgaris/diagnosis , Acne Vulgaris/drug therapy , Keratolytic Agents/administration & dosage , Severity of Illness Index , Tretinoin/administration & dosage , Administration, Topical , Adolescent , Adult , Child , Double-Blind Method , Drug Administration Schedule , Drug Compounding , Female , Humans , Keratolytic Agents/chemistry , Middle Aged , Treatment Outcome , Tretinoin/chemistry , Young Adult
12.
J Drugs Dermatol ; 18(3): 279-284., 2019 Mar 01.
Article in English | MEDLINE | ID: mdl-30909333

ABSTRACT

Background: Fixed combinations are commonplace in dermatology, providing significant efficacy and tolerability benefits. In some cases, two active ingredients complement each other providing a cumulative or additive effect. In rarer cases, a synergistic effect may be seen where the sum of the two active ingredients combined action is greater than the sum of the efficacy of the constituent parts. Objective: To determine whether a novel halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) fixed combination lotion provides a synergistic effect in the treatment of moderate-to-severe plaque psoriasis. Methods: Post hoc analysis of 212 patients with moderate-to-severe plaque psoriasis randomized (2:2:2:1) to HP/TAZ lotion, HP, TAZ or vehicle once-daily for 8 weeks, with a 4-week posttreatment follow-up. Treatment success was evaluated based on two outcomes: percent of patients achieving at least a 2-grade improvement in Investigator Global Assessment (IGA) and IGA score equating to 'clear' or 'almost clear'; and percent change from baseline in the IGAxbody surface area (BSA) score, an alternative to assessing response to therapy that is more sensitive to area change than the Psoriasis Area Severity Index (PASI). In addition, a clinically meaningful outcome was reported in patients who achieved a 75% reduction in IGAxBSA. Synergy was established when the benefit of combination HP/TAZ lotion was greater than benefit of HP plus TAZ, with a ratio (HP/TAZ divided by HP+TAZ) >1.0. Results: HP/TAZ lotion was synergistic at week 8, and four weeks posttreatment. At week 8, treatment success with HP/TAZ lotion relative to vehicle was 42.8% compared with 32.5% for HP plus TAZ (ratio 1.3); and percent change from baseline in IGAxBSA score relative to vehicle was 51.6% compared with 40.6% for HP plus TAZ (ratio 1.3). At week 12, treatment success with HP/TAZ lotion relative to vehicle was 31.3% compared with 20.0% for HP plus TAZ (ratio 1.6). Percent change from baseline in IGAxBSA score relative to vehicle was 47.3% compared with 34.2% for HP plus TAZ (ratio 1.4). HP/TAZ lotion also provided synergistic benefits in terms of achieving a clinically meaningful outcome, with a ratio of 1.3 and 2.0 at weeks 8 and 12. Conclusions: Halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) fixed combination lotion provides a synergistic benefit in the treatment of moderate-to-severe plaque psoriasis. In addition, by combining two agents into one once-daily formulation, this novel formulation reduces the number of product applications and may help patient adherence. J Drugs Dermatol. 2019;18(3):279-284.


Subject(s)
Clobetasol/analogs & derivatives , Dermatologic Agents/therapeutic use , Nicotinic Acids/therapeutic use , Psoriasis/drug therapy , Administration, Cutaneous , Clobetasol/pharmacology , Clobetasol/therapeutic use , Dermatologic Agents/pharmacology , Drug Combinations , Drug Synergism , Follow-Up Studies , Humans , Nicotinic Acids/pharmacology , Psoriasis/diagnosis , Severity of Illness Index , Skin Cream , Treatment Outcome
13.
J Drugs Dermatol ; 18(6): 542, 2019 Jun 01.
Article in English | MEDLINE | ID: mdl-31251546

ABSTRACT

Background: Tazarotene has been extensively studied in clinical trials and is widely used to treat acne vulgaris (acne). Irritation potential has limited its use. Objective: To compare efficacy, safety, and tolerability of a novel formulation tazarotene 0.045% lotion based on polymeric emulsion technology, and tazarotene 0.1% cream in patients with moderate-to-severe acne. Methods: A total of 210 patients, 12 years and older were randomized to receive tazarotene 0.045% lotion, tazarotene 0.1% cream, or respective vehicle in double-blind, randomized, vehicle-controlled, 12-week study evaluating safety and efficacy (inflammatory and noninflammatory lesion counts and using Evaluator Global Severity Scores [EGSS]). In addition, patients completed a patient satisfaction survey (PSS), and acne-specific quality of life (QoL) questionnaire. Safety and cutaneous tolerability were assessed throughout. Results: A novel tazarotene 0.045% lotion demonstrated statistically significant superiority to vehicle in reducing inflammatory and noninflammatory lesion counts (P=.006 and P<.001) and clearly more effective in treatment success at week 12. In addition, at less than half the concentration, tazarotene 0.045% lotion was numerically more effective than tazarotene 0.1% cream. Mean percent reductions in inflammatory and noninflammatory lesions were 63.8% and 56.9%, compared with 60.0% and 54.1% with tazarotene 0.1% cream at week 12. Treatment success assessed by the investigator or patients' self-assessment was also numerically greater with tazarotene 0.045% lotion. There were no significant differences in patient satisfaction or QoL between the two active treatments. Both were well-tolerated, however, there were more treatment-related adverse events with tazarotene 0.1% cream (5.6% versus 2.9%); most common being application site pain. Limitations: This study was primarily designed to direct the phase 3 program and some of the results are post hoc analyses. Conclusions: A novel tazarotene 0.045% lotion provides statistically significant greater efficacy than vehicle in terms of lesion reduction, and numerically better treatment success than tazarotene 0.1% cream; with a highly favorable safety and tolerability profile in moderate-to-severe acne patients. J Drugs Dermatol. 2019;18(6):542-548.


Subject(s)
Acne Vulgaris/drug therapy , Nicotinic Acids/administration & dosage , Pain/epidemiology , Skin Cream/administration & dosage , Acne Vulgaris/diagnosis , Adolescent , Adult , Dose-Response Relationship, Drug , Double-Blind Method , Emulsions , Female , Humans , Male , Nicotinic Acids/adverse effects , Pain/diagnosis , Pain/etiology , Pain Measurement , Patient Satisfaction , Quality of Life , Severity of Illness Index , Skin Cream/adverse effects , Treatment Outcome , Young Adult
14.
Pediatr Dermatol ; 36(2): 193-199, 2019 Mar.
Article in English | MEDLINE | ID: mdl-30656753

ABSTRACT

BACKGROUND: Acne vulgaris (acne) is a common skin condition in children and adolescents. Efficacy of tretinoin is well documented in studies that included pediatric patients (12-18 years of age). With acne routinely presenting in younger patients, data are needed in this important group. Lotion formulations are commonly used across dermatology and are well liked by patients. OBJECTIVE: To evaluate the safety and efficacy of a novel once-daily tretinoin 0.05% lotion in preadolescent subjects (≤ 13 years) with moderate-to-severe acne. METHODS: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies in moderate-to-severe acne. Preadolescent subjects (N = 154) randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory/noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator's Global Severity Score [EGSS] and clear/almost clear). Safety, adverse events (AEs), and cutaneous tolerability evaluated throughout. RESULTS: At Week 12, mean percent reduction in inflammatory and noninflammatory lesion counts were 49.5% and 44.0% compared with 31.4% and 18.8% with vehicle (both P = 0.001). Treatment success was achieved by 23.7% of subjects by Week 12, compared with 7.2% (P = 0.009). The majority of AEs were mild and transient: most frequently were application site pain (5.6%) and application site dryness (2.8%). Local cutaneous safety and tolerability assessments were generally mild-to-moderate and improved by Week 12. CONCLUSIONS: Tretinoin 0.05% lotion was significantly more effective than vehicle in achieving treatment success and reducing inflammatory and noninflammatory lesions in preadolescent acne. It was well tolerated, with all treatment-related AEs deemed mild or moderate.


Subject(s)
Acne Vulgaris/drug therapy , Keratolytic Agents/administration & dosage , Tretinoin/administration & dosage , Administration, Cutaneous , Adolescent , Child , Double-Blind Method , Female , Humans , Keratolytic Agents/adverse effects , Male , Patient Satisfaction/statistics & numerical data , Quality of Life , Severity of Illness Index , Skin/pathology , Treatment Outcome , Tretinoin/adverse effects
16.
J Am Acad Dermatol ; 78(1): 81-89.e5, 2018 Jan.
Article in English | MEDLINE | ID: mdl-28985956

ABSTRACT

BACKGROUND: Individuals with psoriasis are at increased risk for psychiatric comorbidities, including suicidal ideation and behavior (SIB). OBJECTIVE: To distinguish between the underlying risk and potential for treatment-induced psychiatric adverse events in patients with psoriasis being treated with brodalumab, a fully human anti-interleukin 17 receptor A monoclonal antibody. METHODS: Data were evaluated from a placebo-controlled, phase 2 clinical trial; the open-label, long-term extension of the phase 2 clinical trial; and three phase 3, randomized, double-blind, controlled clinical trials (AMAGINE-1, AMAGINE-2, and AMAGINE-3) and their open-label, long-term extensions of patients with moderate-to-severe psoriasis. RESULTS: The analysis included 4464 patients with 9161.8 patient-years of brodalumab exposure. The follow-up time-adjusted incidence rates of SIB events were comparable between the brodalumab and ustekinumab groups throughout the 52-week controlled phases (0.20 vs 0.60 per 100 patient-years). In the brodalumab group, 4 completed suicides were reported, 1 of which was later adjudicated as indeterminate; all patients had underlying psychiatric disorders or stressors. LIMITATIONS: There was no comparator arm past week 52. Controlled study periods were not powered to detect differences in rare events such as suicide. CONCLUSIONS: Comparison with controls and the timing of events do not indicate a causal relationship between SIB and brodalumab treatment.


Subject(s)
Antibodies, Monoclonal/adverse effects , Depressive Disorder/epidemiology , Depressive Disorder/etiology , Psoriasis/drug therapy , Psoriasis/psychology , Adult , Age Factors , Antibodies, Monoclonal/therapeutic use , Antibodies, Monoclonal, Humanized , Clinical Trials, Phase II as Topic , Clinical Trials, Phase III as Topic , Depressive Disorder/physiopathology , Double-Blind Method , Female , Humans , Incidence , Male , Middle Aged , Prognosis , Psoriasis/epidemiology , Psychometrics , Randomized Controlled Trials as Topic , Risk Assessment , Sex Factors , United States
17.
J Neurol Phys Ther ; 41 Suppl 3: S3-S9, 2017 07.
Article in English | MEDLINE | ID: mdl-28628590

ABSTRACT

PURPOSES: To present the history and aims of the STEP conferences; describe the interdependence of prevention, prediction, plasticity, and participation; reflect on where we stand today regarding those 4 Ps; and discuss how future neurorehabilitation should look for individuals with movement disorders. KEY POINTS: Physical therapists have focused primarily on tertiary prevention, emphasizing primary/secondary prevention far less. Predicting optimal response to intervention is essential for primary prevention. Research examining neurorehabilitation effects mediated by brain plasticity is evolving from an emphasis on impairment outcomes toward examination of participation outcomes. CLINICAL PRACTICE RECOMMENDATIONS:: (1) Capitalize on primary and secondary prevention. (2) Administer simple, environmentally relevant predictive measures. (3) Partner with researchers to examine exercise-induced brain plasticity effects via neuroimaging. (4) Encourage physical activity to promote secondary prevention of lifestyle-related diseases and enhance participation. (5) Integrate psychological/social sciences with physiological sciences to move forward with advances in mindful health and patient-centered practices.


Subject(s)
Congresses as Topic , Movement Disorders/rehabilitation , Neurological Rehabilitation/trends , Humans , Neuroimaging , Neurological Rehabilitation/methods
18.
Eur J Pediatr ; 176(9): 1259-1262, 2017 Sep.
Article in English | MEDLINE | ID: mdl-28660313

ABSTRACT

Early identification of autism facilitates referral for early intervention services, shown to be effective in enhancing parent-child interaction as well as adaptive behavior, communication, and socialization. Traditional hallmarks for the diagnosis of autism spectrum disorder (ASD) include deficits in social communication and social interaction as well as stereotypic or repetitive behavioral patterns. Research during the past decade suggests that developmental motor delays during early childhood may also be important predictors of this difficult-to-make diagnosis. The purpose of this short communication is to describe specific research findings about developmental motor delays and other neuromotor concerns that may contribute to the early diagnosis of ASD and thus hasten referral for early therapeutic intervention. CONCLUSION: In that there is reasonable consensus that motor delays during the first year of life may represent a prodrome of ASD, pediatricians should not rule out the possibility of ASD in infants with concerning motor behaviors. What is Known: • Early identification of autism facilitates referral for early intervention services. • Traditional hallmarks for diagnosis of autism spectrum disorder (ASD) include deficits in social communication and social interaction as well as repetitive patterns of behavior. What is New: • Recent research suggests that developmental motor delays during early childhood may also be important predictors of ASD. • Pediatricians should consider the possibility of ASD in infants with motor delays or other concerning motor behaviors.


Subject(s)
Autism Spectrum Disorder/diagnosis , Child Behavior , Child Development , Motor Skills , Social Behavior , Child, Preschool , Developmental Disabilities/etiology , Early Diagnosis , Female , Humans , Infant , Infant, Newborn , Male , Parents , Risk Factors
19.
Pediatr Phys Ther ; 29 Suppl 3: S2-S9, 2017 07.
Article in English | MEDLINE | ID: mdl-28654472

ABSTRACT

PURPOSES: To present the history and aims of the STEP conferences; describe the interdependence of prevention, prediction, plasticity, and participation; reflect on where we stand today regarding those 4 Ps; and discuss how future neurorehabilitation should look for individuals with movement disorders. KEY POINTS: Physical therapists have focused primarily on tertiary prevention, emphasizing primary/secondary prevention far less. Predicting optimal response to intervention is essential for primary prevention. Research examining neurorehabilitation effects mediated by brain plasticity is evolving from an emphasis on impairment outcomes toward examination of participation outcomes. CLINICAL PRACTICE RECOMMENDATIONS:: (1) Capitalize on primary and secondary prevention. (2) Administer simple, environmentally relevant predictive measures. (3) Partner with researchers to examine exercise-induced brain plasticity effects via neuroimaging. (4) Encourage physical activity to promote secondary prevention of lifestyle-related diseases and enhance participation. (5) Integrate psychological/social sciences with physiological sciences to move forward with advances in mindful health and patient-centered practices.


Subject(s)
Movement Disorders/therapy , Neurological Rehabilitation/methods , Neurological Rehabilitation/trends , Physical Therapy Modalities/trends , Forecasting , Humans
20.
Cardiol Young ; 26(4): 650-7, 2016 Apr.
Article in English | MEDLINE | ID: mdl-26047495

ABSTRACT

UNLABELLED: Aims To describe the motor proficiency of 5-year-old children who underwent early infant cardiac surgery and had atypical infant gross motor development. To identify risk factors for motor dysfunction at 5 years of age. METHODS: A total of 33 children (80.5% participation rate) were re-assessed by a physiotherapist blinded to the diagnosis and previous clinical course, using standardised motor assessment tools. RESULTS: Motor proficiency was categorised as below average or well below average in 41% of the study patients. Approximately 30% of the cohort had balance deficits. Motor abilities at 4 months and 2 years of age were associated with motor proficiency at age 5; however, atypical motor development in infancy was not predictive of below-average or well below-average scores at age 5. Risk factors associated with motor ability at age 5 included respiratory support and intensive care length of stay in the 1st year of life, asymmetrical crawling in infancy, and cyanotic CHD at age 5. CONCLUSIONS: Despite differences from other reported studies in terms of cohort diagnoses and age at surgery, the rate of motor dysfunction was similar, with rates much higher than expected in typical children. Further assessment is needed in later childhood to determine the significance of these findings.


Subject(s)
Cardiac Surgical Procedures , Motor Skills , Cardiac Surgical Procedures/adverse effects , Child, Preschool , Developmental Disabilities/epidemiology , Developmental Disabilities/etiology , Female , Heart Defects, Congenital/surgery , Humans , Male , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Prospective Studies , Risk Factors
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