Volume restoration of hands with polycaprolactone by cannula delivery; a prospective single center consecutive case series evaluation.

Background: Dorsal hand volume loss results in the perception of aging appearance. Several volumizing fillers have been used for this correction.Objective: To report restoration of dorsal hand volume using cannula delivery of Polycaprolactone (PCL) microspheres and to assess efficacy, duration, and safety up to 3 years post treatment.Method: Fifteen patients with volume loss of their hands were evaluated by clinical examination, photography and a hand volume grading scale. PCL was injected by 25 G cannula after locating dorsal veins using a viewing laser to avoid intravascular injections. Patients' satisfaction and grade of severity were reevaluated at early (3-6 months) and late (12-18 months) timepoints following the procedure. A second treatment was offered if desired by the patient.Results: Eight participants required one treatment session to achieve satisfaction. Five had two treatments. Patients requiring a second treatment were reassessed after 12 months. All patients had improvements on the severity score by the end of the evaluation period. Side effects were minimal and transient. No patients developed bruising.Conclusion: PCL injections are reliable method for hand volumization. Results persisted for up to 3 years in some patients. Laser vein viewer and cannula delivery ensure uniform injections and avoid intravascular injuries.

Photodynamic Therapy: A Clinical Consensus Guide.

BACKGROUND: The American Society of Dermatologic Surgery (ASDS) periodically develops consensus documents for its members concerning various aspects of dermatologic surgery. Advances in photodynamic therapy (PDT) have been many and PDT use has been established in a variety of skin conditions. OBJECTIVE: The ASDS board of directors proposed a committee of experts in the field to develop consensus documents on different treatments. An expert panel reviewed the literature on PDT and discussed the findings. The consensus was reached with evidence-based recommendations on different clinical applications for PDT. PATIENTS AND METHODS: This consensus document includes discussions regarding PDT, including different photosensitizers and various light source activators, historical perspective, mechanism of action, various therapeutic indications and expected outcomes, pre- and post-care, and management of adverse outcomes. RESULTS: Photodynamic therapy is highly effective for pre-cancerous lesions, superficial nonmelanoma skin cancers, inflammatory acne vulgaris and other conditions. New protocols including laser mediated PDT significantly improve results for several indications. CONCLUSION: The ASDS consensus document on PDT will be helpful for educating members on safe and effective PDT for a variety of indications.

Botulinum toxin type B: pH change reduces injection pain, retains efficacy.

BACKGROUND: Injection of botulinum toxin Type B (BTX-B) is substantially more painful than injection of botulinum toxin Type A (BTX-A). OBJECTIVE: A method of reducing pain with BTX-B injection without reducing efficacy. This was evaluated in 2 BTX-A-resistant subjects and another BTX-B-naive subject. METHODS: Clinical evaluation and computer analysis of photographs were used to confirm efficacy to different dilutions of Type B toxin and confirm BTX-A resistance. A pilot study of 3 subjects involves BTX-B (usually pH 5.6) that was diluted with sodium bicarbonate to normalize the pH to 7.5 in the syringe immediately before injection. Pain assessment compared the different pH BTX-B solutions. RESULTS: Two patients with acquired resistance to 3 BTX-As in upper facial muscles responded to BTX-B. Injection pain of BTX-B changed to pH 7.5 was significantly reduced and retained efficacy over 10 weeks. CONCLUSION: Botulinum toxin Type A resistance is documented to 3 BTX-A brands in 2 patients. They had received low doses of Type A toxin, they responded to Type B toxin. Injection pain of the acidic solution of BTX-B neurotoxin was reduced and efficacy not compromised by changing pH of BTX-B solution to pH 7.5. This method improved patient tolerance to BTX-B injections.

Four methods of evaluation of facial erythema and pigment treated with intense pulsed light or cream.

AIM: To evaluate methods of evaluation of patients with mild to moderate facial pigmentation or erythema and compare clinical and photographic grading with instrumental evaluation. METHODS: Of the 24 female subjects treated, 12 were treated with intense pulsed light (IPL) and 12 were treated with daily cream program. Evaluations before and at 16 weeks consisted of: 1. Clinical examination and severity grading by a dermatologist without knowledge of treatment given. 2. Standardised photographs were evaluated by two other dermatologists without knowledge of treatment given. 3. A computer controlled photographic skin analysis systems was used to grade severity of erythema and pigmentation. 4. Subjects were asked to assess their response at the end of a 16-week period, that is, subject self-evaluation. RESULTS: On clinical evaluation of IPL subjects, 12 showed improvement. Of the cream subjects, 11 showed improvement. There was correlation between dermatologist facial examination and the instrumental method. Overall the different assessments showed a slightly greater trend for improvement with IPL treatments for erythema and pigmentation, but no statistical differences were found between the treatments using Student's t-test and Anova analysis of comparative improvement.

Three-dimensional digital surface imaging measurement of the volumizing effect of injectable poly-L-lactic acid for nasolabial folds.

INTRODUCTION: Injectable poly-l-lactic acid (PLLA) is a biocompatible and biodegradable polymer device indicated in Europe for correction of facial contour deficiencies, with a gradual onset of effect that is maintained for up to 25 months. METHODS: In this single-centre, open-label study, 20 adult subjects seeking treatment for facial contour deficiencies were treated with injectable PLLA every 4-6 weeks for ≤6 months or until optimal correction (0 or 1 on nasolabial photonumeric wrinkle assessment scale [0 = no wrinkles; 5 = very deep wrinkles, redundant fold]). 3-D digital surface imaging and standardized 2-D photography were used to assess mid-face and nasolabial volumetric correction and clinical improvement, respectively. RESULTS: Based on 3-D digital surface imaging, statistically significant increases in average mid-facial volume occurred with injectable PLLA after the first injection session and persisted through to the end of treatment. Investigator and subject ratings of 'much improved' or 'excellent' improvement were reported using 2-D photographs as a visual aid. Subjects reported high levels of satisfaction. No serious adverse events were reported. DISCUSSION: In this study, injectable PLLA was found to be safe and effective for mid-face and nasolabial fold volumetric correction.

Investigator global evaluations of efficacy of injectable poly-L-lactic acid versus human collagen in the correction of nasolabial fold wrinkles.

BACKGROUND: Injectable poly-L-lactic acid (PLLA) is indicated in the United States for use in immune-competent patients for correction of shallow-to-deep nasolabial fold contour deficiencies and other facial wrinkles in which a deep dermal grid pattern injection technique is appropriate. It is also indicated for restoration and/or correction of signs of lipoatrophy in patients with human immunodeficiency virus. OBJECTIVE: The authors examine the efficacy of injectable PLLA for correction of nasolabial fold wrinkles, based on Investigator Global Evaluations (IGE). METHODS: A randomized, multicenter, subject-blinded, parallel-group study compared injectable PLLA versus human collagen for correction of nasolabial fold wrinkles for 13 months after up to four treatments (intent-to-treat population, 233). Injectable PLLA-treated subjects were followed up for an additional 12 months (total, 25 months) after the final treatment session. Efficacy was also assessed through secondary IGE for improvement, which is the subject of this report. RESULTS: IGE reports of improvement were significantly greater in subjects who received injectable PLLA versus those who received human collagen (p < .001). Overall improvement with injectable PLLA was 100% three weeks after the final treatment, remaining above 85% through month 25. Overall IGE of improvement with human collagen declined from 94.0% at week three to 6.0% at month 13. Both treatment groups had similar safety profiles. CONCLUSIONS: IGE of improvement were significantly greater with injectable PLLA treatment than with human collagen treatment at all time points following the last treatment. Injectable PLLA treatment continued to show a beneficial effect for up to 25 months.

Assessment of Natural Sunlight Protection Provided by 10 High-SPF Broad-Spectrum Sunscreens and Sun-Protective Fabrics.

In 1978, the FDA Advisory Panel proposed both indoor and natural sunlight SPF testing methods but reverted to indoor testing only in 1993. Today's sunscreen sun protection and broad-spectrum claims are based on mandated clinical tests using solar simulators and in vitro spectrophotometers. This research evaluated the protection of 10 high-SPF (30-110), broad-spectrum sunscreen products, as well as 6 sun-protective fabrics against natural sunlight in Arequipa, Peru. Each of the 17 subjects was exposed to natural sunlight for 1 h and 59 min under clear skies, with temperatures and humidity similar to those in an indoor clinical laboratory. Test sites were photographed 16-24 h later. Four dermatologists evaluated the photographs for erythema and persistent pigment darkening (PPD). Perceptible sun-induced skin injury (sunburn and/or pigmentation) was detected at 97% of the sunscreen-protected scores. The most sun-sensitive subjects obtained the least erythema protection. The higher the SPF was, the higher the erythema protection, but the intensity of PPD was also higher. The 2 sunscreens using only FDA-approved sunscreen filters rated 30 SPF and 45+ SPF performed poorly: Eighty-one percent of the 136 scores were graded 1 minimal erythema dose or higher erythema, achieving, at a maximum, SPF of 5-7 in natural sunlight. Sun-protective fabrics tested provided excellent sun protection. The erythema and PPD observed through the sunscreens in less than 2 h are incongruous with the broad-spectrum, high-SPF sunscreen claims. Reapplying these sunscreens and staying in the sun longer, as stated on the product labels, would have subjected the subjects to even more UV exposure. High-SPF, broad-spectrum sunscreen claims based on indoor solar simulator testing do not agree with the natural sunlight protection test results.

Cannabis, alcohol and other drug findings in fatally injured drivers in Ontario.

OBJECTIVE: The purpose of this study was to determine the prevalence of cannabis, alcohol and other drug use in drivers of motor vehicles who died in crashes in the Canadian province of Ontario from January 2016 through December 2018 along with the characteristics of these drivers and some of the circumstances of the crash in which they were involved. METHODS: Toxicological tests were performed on blood samples obtained from 921 driver fatalities for whom postmortem blood samples were submitted to the Center of Forensic Sciences for analysis. The results were coded into a database along with basic demographic and crash characteristics and examined for prominent characteristics and patterns. RESULTS: Overall, among the 921 cases examined, 495 (53.7%) tested positive for alcohol, cannabis (tetrahydrocannabinol or THC), or another psychoactive drug. The number of cases that tested positive for THC (251) exceeded the number of cases that tested positive for alcohol (241) as well as the number that tested positive for a drug other than THC (235). In 38% of positive cases, more than one substance was detected. Alcohol and THC were most commonly detected among males; females most frequently tested positive for a drug other than THC, notably medications with depressant effects. Alcohol-involved driver fatalities were most common on weekends and most likely involved single vehicle crashes. Driver fatalities that tested positive for THC or another drug were more evenly distributed throughout the week and were more likely to have been in multi-vehicle crashes. CONCLUSIONS: The present study highlights the use of cannabis and other drugs by drivers. The patterns of crashes and the characteristics of drivers involved indicate that the characteristics of driver fatalities involving cannabis and/or other drug use differ from those of alcohol and require new, innovative approaches targeting high-risk times, groups and behaviors. Continued monitoring of the toxicological findings from blood samples obtained from drivers killed in motor vehicle crashes will be a key element in efforts to reduce the impact of drug use by drivers on road safety.

Homeostatic control of nuclear-encoded mitochondrial gene expression by the histone variant H2A.Z is essential for neuronal survival.

Histone variants are crucial regulators of chromatin structure and gene transcription, yet their functions within the brain remain largely unexplored. Here, we show that the H2A histone variant H2A.Z is essential for neuronal survival. Mice lacking H2A.Z in GABAergic neurons or Purkinje cells (PCs) present with a progressive cerebellar ataxia accompanied by widespread degeneration of PCs. Ablation of H2A.Z in other neuronal subtypes also triggers cell death. H2A.Z binds to the promoters of key nuclear-encoded mitochondrial genes to regulate their expression and promote organelle function. Bolstering mitochondrial activity genetically or by organelle transplant enhances the survival of H2A.Z-ablated neurons. Changes in bioenergetic status alter H2A.Z occupancy at the promoters of nuclear-encoded mitochondrial genes, an adaptive response essential for cell survival. Our results highlight that H2A.Z fulfills a key, conserved role in neuronal survival by acting as a transcriptional rheostat to regulate the expression of genes critical to mitochondrial function.

A randomized study of the efficacy and safety of injectable poly-L-lactic acid versus human-based collagen implant in the treatment of nasolabial fold wrinkles.

BACKGROUND: Injectable poly-L-lactic acid (PLLA) is a synthetic, biodegradable, biocompatible polymer device. OBJECTIVE: We sought to compare the efficacy and safety of injectable PLLA with human-derived collagen in treating nasolabial fold wrinkles. METHODS: In this randomized, evaluator-blinded, parallel-group, multicenter study, subjects received injectable PLLA (n = 116) or collagen (n = 117) injections (1-4 visits, 3-week intervals). Wrinkle Assessment Scale scores were calculated at screening; posttreatment week 3; months 3, 6, 9, and 13 (injectable PLLA or collagen groups); and months 19 and 25 (injectable PLLA group). Safety data were obtained from subject interviews and case report forms. RESULTS: Injectable PLLA significantly improved mean Wrinkle Assessment Scale scores (all time points, P < .001). Improvements (up to 25 months after last treatment) were significantly greater (P < .001) than with collagen for posttreatment months 3 to 13. LIMITATIONS: Mostly white women and subjects with Fitzpatrick skin types II and III were included. CONCLUSION: Injectable PLLA provides well-tolerated, effective, and long-lasting (up to 25 months) nasolabial fold wrinkle correction.

A phase IIa open-label dose-escalation pilot study using allogeneic human dermal fibroblasts for nasolabial folds.

BACKGROUND AND OBJECTIVE: The correction of soft tissue contour defects and dermal atrophy is a growing area driven by medical and aesthetic need. Deterioration of the skin's appearance occurs as a result of age and trauma, such as surgery, infections, and acne. Typically, imperfections are treated with volume-correcting fillers. This study evaluated allogeneic human dermal fibroblasts (HDFs) for the treatment of nasolabial folds as an alternative strategy to improve the structure, texture, and quality of the skin. METHODS AND MATERIALS: In this phase IIa study, a suspension of allogeneic HDF (2 × 10(6) cells/mL or 2 × 10(7) cells/mL) was injected intradermally along the nasolabial fold; line severity was assessed using a photographic scale. RESULTS: Mean investigator satisfaction was 7.4 (range 4.7-9.5) at 12 weeks and 7.6 (range 4.4-9.8) at 24 weeks. Subject satisfaction scores were 7.0 (range 0.1-10.0) at 12 weeks and 7.8 (range 1.5-10.0) at 24 weeks. All patients experienced adverse events, the majority of which were deemed treatment related. Most were mild to moderate in severity and resolved completely. CONCLUSION: This study demonstrated that allogeneic HDF can produce an improvement in aesthetic appearance with minimal adverse events and warrants further investigation and development. Intercytex provided financial support for this study. John Roberts is an employee of Intercytex.

Dosing, efficacy and safety plus the use of computerized photography for botulinum toxins type A for upper facial lines.

INTRODUCTION: Several studies confirm that botulinum toxins type A (BTX-A) are effective for reducing facial lines caused by hyperactive muscles. Two different commercial types of BTX-A currently available are BTX-A-1 (Botox) and BTX-A-2 (Dysport). This paper reports further comparison of dosing, efficacy and safety. METHODS: Sites treated: glabellar, horizontal forehead lines and crow's feet. Different dilutions and dosages were studied with BTX-A-1 and BTX-A-2. The reduction of facial lines was evaluated by investigators and patients. Computerized photographic numerical assessment was also studied in determining the efficacy of BTX-A for crow's feet lines. RESULTS: Study 1: Injecting glabellar lines at doses of BTX-A-1 (30 units) and BTX-A-2 (75 units) (2.5:1 ratio BTX-A2:BTX-A1) showed similar efficacy. Study 2: BTX-A-2 (256 units total) was significantly more effective than BTX-A-1 (64 units total) (i.e. a dose ratio of 4:1) for upper face lines. No differences in the side-effect profiles between the two toxins were observed in either study. Study 3: A computerized photographic numerical assay was an objective assessment of crow's feet severity. Using a dose ratio of BTX-A-2 to BTX-A-1 of 3:1 showed a trend towards BTX-A-2 superiority. CONCLUSION: Two different botulinum toxins type A were shown to be effective and safe for hyperfunctional facial lines. The choice of dose, dilution and placement is critical for each individual toxin. Computerized photography gave numerical severity scores of crow's feet severity.

Injectable poly-L-lactic acid for cosmetic enhancement: learning from the European experience.

Currently a diverse range of injectable agents are used for noninvasive facial enhancement. Injectable poly-L-lactic acid (PLLA) is a biocompatible, biodegradable, synthetic polymer that is approved for correction of HIV-related facial lipoatrophy in Europe, Canada, and the United States. PLLA is also approved in several countries for cosmetic purposes, and is under review in the United States for this indication. After injection, PLLA elicits a gradual increase in facial volume via hypothesized endogenous production of fibroblasts and, subsequently, collagen, enabling global facial rejuvenation to be tailored, as required, over time. Substantial increases in dermal thickness after injection of PLLA have been observed to last for up to 2 years. This article reviews the use of PLLA in Europe and the United States with regard to practitioner experiences and techniques for optimizing outcomes. Correct reconstitution and administration of PLLA have been found to be important parameters for optimal use of this agent.

Injectable poly-l-lactic acid: 3 years of aesthetic experience.

BACKGROUND: Injectable poly-l-lactic acid (PLLA) has been used to correct age- or disease-related facial volume deficits. OBJECTIVE: This single-center, retrospective survey evaluated PLLA for cosmetic use. METHODS AND MATERIALS: A questionnaire was mailed to 281 patients treated with PLLA 6 months or more previously. PLLA was reconstituted 4 hours or more before injection with 5 mL of sterile water plus 1 mL of 1% xylocaine added before injection. RESULTS: Two hundred twenty-one patients responded (210 female; average age 54.3; average treatments 3.3 per patient); the majority had received facial injections. Transient side effects included bruising, swelling, and discomfort. After treatment (1-6 months), 14/41 patients developed Grade 1 papules or nodules (slightly palpable, nonvisible; clinically nonrelevant; all resolved spontaneously), 15/41 developed Grade 2 papules or nodules (palpable, slightly visible; clinically nonrelevant; all resolved spontaneously), and 12/41 developed Grade 3 nodules (easily palpable, obviously visible [9 perioral; 3 periorbital or temple]; 5 resolved spontaneously; 7 were treated [5 intralesional corticosteroids; 2 surgery]). CONCLUSION: Patients treated with PLLA experienced duration of improvement of up to 24 months. Maximum improvement took several treatment sessions. Nodules occurred in perioral and periorbital regions, so incidence is reduced by avoiding these areas.

Botulinum toxin type A in the treatment of primary axillary hyperhidrosis: a 52-week multicenter double-blind, randomized, placebo-controlled study of efficacy and safety.

BACKGROUND: The long-term effects of botulinum toxin type A (BoNTA) on the global impairment associated with severe primary axillary hyperhidrosis have not been comprehensively assessed relative to placebo. OBJECTIVE: To assess the efficacy and safety of 2 dosages of BoNTA compared with placebo in subjects with primary axillary hyperhidrosis. METHODS: Subjects (N = 322) were randomized to the use of BoNTA (75 U or 50 U/axilla) or placebo in this 52-week, multicenter, double-blind study. RESULTS: BoNTA treatment significantly reduced daily activity limitations at 4 weeks after injection. A 2-point improvement on the 4-point Hyperhidrosis Disease Severity Scale (HDSS) was reported in 75% of subjects in the 75-U and 50-U BoNTA groups and in 25% of the placebo group (P < .001). Improvements in HDSS scores were corroborated by gravimetric results. The median duration of effect was 197 days, 205 days, and 96 days in the 75-U, 50-U, and placebo groups, respectively. BoNTA was well tolerated. LIMITATIONS: The effect of total surface area involvement on treatment efficacy was not evaluated. CONCLUSION: BoNTA treatment effectively reduces the symptoms of primary axillary hyperhidrosis and is well tolerated.

Current and emerging therapeutic modalities for hyperhidrosis, part 1: conservative and noninvasive treatments.

Approximately 1% to 3% of the US population has hyperhidrosis (HH). HH can be an incapacitating medical condition because it not only hinders patient quality of life but also causes the secondary effect of excess cutaneous sweat. There is a broad spectrum of treatment modalities including topical and systemic therapies, iontophoresis, localized neuroinhibitory injections, and surgical interventions. This article reviews HH and the conservative treatments for the condition.

Current and emerging therapeutic modalities for hyperhidrosis, part 2: moderately invasive and invasive procedures.

Hyperhidrosis (HH) hinders patient quality of life and causes the secondary effect of excess cutaneous sweat. Treatment modalities include conservative and noninvasive therapies such as topical agents and iontophoresis. This article reviews moderately invasive and invasive procedures, such as botulinum toxin, curettage, and endoscopic thoracic sympathectomy (ETS), and compares their advantages and disadvantages in safety and efficacy.

The use of photodynamic therapy in dermatology: results of a consensus conference.

Photodynamic therapy (PDT) has significant promise in improving outcomes of patients with a variety of cutaneous conditions. A group of experts met to review the principles, indications, and clinical benefits of PDT with 5-aminolevulinic acid (ALA). They also reviewed PDT with methyl aminolevulinate. The experts established consensus statements for pretreatment, posttreatment, ALA contact time, light sources, and numbers of sessions associated with ALA PDT for actinic keratosis and superficial basal cell carcinoma, photorejuvenation and cosmetic enhancement, acne, sebaceous skin, rosacea, and rhinophyma. They based consensus recommendations on their clinical experience and the medical literature. They also suggested future applications of ALA PDT. Experts concluded that ALA PDT is a safe and effective modality for the treatment of conditions commonly encountered in dermatology. Since downtime is minimal, the technique is suitable for patients of all ages and lifestyles. Appropriate light sources are available in many dermatology offices. The expanding clinical and financial benefits of PDT justify the purchase of an appropriate light source.

Efficacy of 0.1% tazarotene cream for the treatment of photodamage: a 12-month multicenter, randomized trial.

OBJECTIVE: To determine the efficacy and safety of 0.1% tazarotene cream for the treatment of photodamage. DESIGN: A 24-week multicenter, double-blind, randomized, vehicle-controlled intervention study followed by a 28-week open-label extension. SETTING: Ambulatory patients in private and institutional practice. PATIENTS: Of 563 patients with facial photodamage, 91% and 86% completed the double-blind and open-label phases, respectively. In the double-blind phase, 20 of 283 tazarotene-treated patients and 1 of 280 vehicle-treated patients discontinued treatment owing to adverse events. INTERVENTION: Once-daily application of 0.1% tazarotene cream or nonmedicated vehicle cream to the face for 24 weeks. Then, all continuing patients received treatment with 0.1% tazarotene cream for another 28 weeks. MAIN OUTCOME MEASURES: Primarily, fine wrinkling and mottled hyperpigmentation. Also, lentigines, elastosis, pore size, irregular depigmentation, tactile roughness, coarse wrinkling, telangiectasia, actinic keratoses, overall integrated assessment of photodamage, global response to treatment, patients' overall assessment of photodamage, and plasma levels of tazarotenic acid. RESULTS: Compared with the vehicle, at week 24 tazarotene resulted in a significantly greater incidence of patients achieving treatment success (>or=50% global improvement) and at least a 1-grade improvement in fine wrinkling, mottled hyperpigmentation, lentigines, elastosis, pore size, irregular depigmentation, tactile roughness, coarse wrinkling, and the overall integrated assessment of photodamage (P<.01). Additional clinical improvement occurred with continued tazarotene treatment and had not plateaued by week 52. Plasma tazarotenic acid concentrations did not exceed 0.71 ng/mL. CONCLUSIONS: Once-daily applications of 0.1% tazarotene cream significantly reduced multiple signs of photodamage. Plasma levels of tazarotenic acid remained below those of endogenous retinoids.

Effect of a single course of isotretinoin therapy on bone mineral density in adolescent patients with severe, recalcitrant, nodular acne.

BACKGROUND: Adverse changes in bone have been reported for patients undergoing high-dose, long-term (several years) isotretinoin therapy for disorders of cornification. The effect of short-term (4-5 months) therapy at the lower dose recommended for acne on bone development in younger, growing adolescent (12-17 years) patients has not been well studied. OBJECTIVE: The purpose of the study was to evaluate the effect of a standard, single course of isotretinoin (Accutane) therapy on bone mineral density (BMD) of the lumbar spine and hip in adolescents ages 12 to 17 years with severe, recalcitrant, nodular acne. METHODS: In this open-label, multicenter study, 217 adolescents (81 girls) with severe, recalcitrant, nodular acne were enrolled and treated with isotretinoin twice daily with food at the recommended total dose of approximately 1 mg/kg for 16 to 20 weeks. BMD in the lumbar spine and hip was measured at baseline and at the end of therapy by dual energy radiograph absorptiometry. RESULTS: There was no clinically significant mean change in BMD measured at the lumbar spine (+1.4%, range: -4.9% to +12.3%) or total hip (-0.26%, range: -11.3% to +15.0%). Hyperostosis was not observed in any patient. Typical efficacy expected in the treatment of acne was observed. CONCLUSIONS: A 16- to 20-week course of isotretinoin treatment at the recommended dose for severe acne has no clinically significant effect on lumbar spine and total hip BMD in the adolescent (12-17 years) population.