Multimodal Clinical Imaging Assessment of the Outcome in Mild-to-Moderate Acne: A Prospective Study.

BACKGROUND: The quality of outcome assessment in acne studies has been either subjective/insufficient or time consuming through the ordinary lesion counting. OBJECTIVE: To evaluate the application of multimodal clinical imaging (MCI), a combination of imaging technology and computation, in the assessment of acne lesions in a clinical study setting. METHODS: A prospective, monocentric, single-group open study designed to evaluate the efficacy and tolerance of a cosmetic product (IP/SG) in subjects with mild-to-moderate facial acne by classical clinical counting (CCC) - change in the total/inflammatory/noninflammatory acne lesion number compared with baseline (D0) - Investigator Global Assessment (IGA) and self-reported outcomes. Concomitantly, MCI was administered. The study was performed for 12 weeks (D84) with a 4-week follow-up (D112). RESULTS: Mean age of patients (n = 49) was 18.2 ± 3.7 years (range 13-25). The mean acne duration was 3.8 ± 2.8 years. The total number of lesions did not differ significantly between D0/D84 by both CCC and MCI. However, the Cardiff Acne Disability Index (CADI) and uncomfortable feeling improved at D28/D0, the perception of oily skin improved at D14/D0, and the perception of sticky skin improved from D28/D0 to D56/D0. Deterioration was detected between D84/D0 and D112/D0, namely after product discontinuation. Interestingly, a change in trend was recorded for acne lesions at D14/D0 by MCI but not by CCC. CONCLUSION: MCI, applied for the first time in a small clinical study setting, is at least as reliable as CCC and may allow for a sensitive longitudinal evaluation of single acne lesions and their response to products, especially in conditions where clinical evaluation reaches its limits.

Assessment of Skin Physiology Change and Safety After Intradermal Injections With Botulinum Toxin: A Randomized, Double-Blind, Placebo-Controlled, Split-Face Pilot Study in Rosacea Patients With Facial Erythema.

BACKGROUND: Botulinum toxin (BTX) has been used cosmetically with good clinical efficacy and tolerable safety. OBJECTIVE: This randomized, double-blind, split-face clinical study aimed to investigate the efficacy and safety of intradermal BTX in patients with rosacea. MATERIALS AND METHODS: Twenty-four participants were enrolled and randomly given intradermal injections of BTX and normal saline in both cheeks. Clinician Erythema Assessment (CEA) score, Global Aesthetic Improvement Scale (GAIS) score, skin hydration, transepidermal water loss (TEWL), melanin content, erythema index, elasticity, and sebum secretions were evaluated at baseline and 2, 4, 8, and 12 weeks. RESULTS: On the BTX-treated side, the CEA score significantly decreased and the GAIS score significantly increased. The erythema index decreased at Weeks 4 and 8. Skin elasticity was improved at Weeks 2 and 4 and skin hydration, at Weeks 2, 4, and 8. However, TEWL and sebum secretion did not show significant differences. CONCLUSION: Intradermal BTX injections reduced erythema and rejuvenated the skin effectively and safely in patients with rosacea.

Assessment of Treatment of Refractory Granuloma Faciale With Intralesional Rituximab.

Importance: Granuloma faciale (GF) is a rare, benign inflammatory dermatosis of unknown cause. Some reports have suggested that it could be part of the spectrum of IgG4-related sclerosing diseases. Granuloma faciale is characterized by single or multiple red-brown nodules, most frequently occurring on the face, and it can produce severe disfigurement. Treatment is difficult, and poor outcomes are often seen. Rituximab is a monoclonal antibody against CD-20 approved by the US Food and Drug Administration for treatment of some autoimmune and tumoral diseases. Objective: To evaluate the treatment of refractory GF with intralesional rituximab. Design, Setting, and Participants: In this case series, 3 patients with biopsy-proved refractory GF who underwent treatment at a dermatology outpatient clinic of a tertiary referral hospital were evaluated. The study was conducted from August 2015 to December 2017. Interventions: Doses of 0.5 to 1 mL/cm2 of intralesional rituximab, 10 mg/mL, were administered monthly for 6 months and thereafter depending on clinical response. In 2 patients, peripheral blood B-cell counts were monitored before and during treatment, and in 1 patient, only during treatment. Main Outcomes and Measures: Reduction in size of the lesions, ultrasonography evaluation, subjective improvement, and adverse events were monitored throughout the course of therapy. Results: All 3 of the patients were men (ages from 30s to 60s). They showed a significant reduction in the size and thickness of GF both clinically and on ultrasonography evaluation. Two patients had a complete response and the third, a partial response. A reduction in peripheral blood B-cell count was observed in the 3 patients, suggesting that the action of rituximab could be systemic. No severe adverse reactions were reported. Conclusions and Relevance: Intralesional rituximab may represent a novel and well-tolerated therapy for refractory GF.

In vivo confocal microscopy efficacy assessment of daylight photodynamic therapy in actinic keratosis patients.

BACKGROUND: Reflectance confocal microscopy (RCM) is a noninvasive diagnostic technique with an acceptable sensitivity and specificity for actinic keratosis (AK). OBJECTIVES: We evaluated efficacy of daylight photodynamic therapy (DL-PDT) in patients with AK using a new RCM atypia scoring system. MATERIALS AND METHODS: All patients with AK lesions (Grade I-II) were included in our study (2012-15). Baseline clinical, dermoscopy and RCM evaluations were followed by DL-PDT. In the first follow-up, clinical examination, dermoscopy and RCM imaging of the treated area were carried out. Atypia scoring and cell size measurements were used to compare before and after RCM images. RESULTS: From 40 lesions (20 patients with mean age of 75·5 years), complete resolution and partial response of the actinic damage was detected in 80% and 17·5% of lesions, respectively. No cellular atypia was seen in the follow-up RCM images of 57·5% of lesions (n = 23), while in 40% of lesions (n = 16) minimal changes to the honeycomb pattern of the epidermis were seen in the follow-up RCM images (atypia score 1). Only one lesion showed minimal or no clinical response, and a persistent moderate amount of atypia in RCM. Furthermore, atypia score and mean cell size decreased significantly in the follow-up DL-PDT RCM images (P < 0·001, P = 0·001, respectively). CONCLUSIONS: RCM features of actinic damage at cellular level have been shown to correlate well with the results of a clinical assessment of AK lesions. This study confirms that in vivo RCM technology might be an additional technique to monitor the efficacy of DL-PDT for AK.

Assessment of efficacy and tolerability of different concentrations of trichloroacetic acid vs. carbon dioxide laser in treatment of xanthelasma palpebrarum.

BACKGROUND: There are numerous methods currently available for the management of xanthelasma. These include surgical excision, laser ablation using a variety of lasers and chemical cauterization. However, each method of treatment is associated with particular limitations and side effects. OBJECTIVES: To assess the clinical efficacy and tolerability of different concentrations of topical trichloroacetic acid (TCA) vs. carbon dioxide laser in the treatment of patients with xanthelasma palpebrarum. METHODS: Thirty patients with xanthelasma palpebrarum were classified into four groups, treated by TCA 35%, 50%, 70%, and CO2 laser, respectively. Lipid profile was estimated for all patients. RESULTS: Both TCA peeling 70% and carbon dioxide laser ablation showed more significant clinical efficacy and tolerability with least number of sessions in the treatment of xanthelasma palpebrarum than 50% and 35% TCA peeling. Post-therapy erythema and hypopigmentation were more with TCA 70%. Post-therapy hyperpigmentation was more with TCA (50%). There was a significant improvement in patients with normal lipid profile than those with abnormal profile. CONCLUSION: Both TCA peeling 70% and carbon dioxide laser ablation are highly effective and well tolerated with least number of sessions in the treatment of xanthelasma palpebrarum.

Erythema of Rosacea: Validation of Patient's Self-Assessment Grading Scale.

BACKGROUND: Facial erythema is a primary feature of rosacea. Currently, no validated scales exist that can accurately capture a patient's self-assessment of their own facial erythema. During phase 2 studies for brimonidine tartrate gel, a 5-point numeric rating scale was developed as a tool to allow subjects to provide an independent assessment of visible changes to the facial erythema associated with their rosacea. OBJECTIVE: The objective of this study was to validate the revised patient's self-assessment (PSA) scale and evaluate it for statistical reliability and validity in quantification of facial erythema of rosacea. METHODS: The validity of the PSA scale was evaluated by assessing the test-retest reliability, construct validity, and known-groups validity based on the data collected during a Phase 2b study on brimonidine gel for the treatment of persistent facial erythema of rosacea. RESULTS: Based on the results of this evaluation, this PSA scale demonstrated test-retest reliability, construct validity, and known-groups validity. LIMITATIONS: Study results are most generalizable to those with moderate to severe erythema. CONCLUSION: The PSA is an appropriate scale to assess facial erythema associated with rosacea.

A randomized clinical trial of photodynamic therapy with methyl aminolaevulinate vs. diclofenac 3% plus hyaluronic acid gel for the treatment of multiple actinic keratoses of the face and scalp.

BACKGROUND: A gel containing diclofenac and hyaluronic acid (DHA) and photodynamic therapy with methyl aminolaevulinate (MAL-PDT) are widely used treatments for actinic keratoses (AKs). OBJECTIVES: The aim of this single-centre, open-label, prospective, nonsponsored, randomized controlled clinical trial was to compare the treatment results and cost-effectiveness of MAL-PDT and DHA. METHODS: Patients with multiple AKs of the face and scalp were randomized to receive MAL-PDT or DHA. After 90 days, the overall complete remission (CR) rate of patients and the CR rate of lesions according to thickness score were assessed, and patients and an investigator scored the cosmetic outcome. In addition, patients scored their overall satisfaction with the treatment. Patients with CR of all lesions were followed up for 12 months. RESULTS: Two hundred patients with a total of 1674 AKs were enrolled. The lesion CR rates at 3 months were 85·9% with MAL-PDT and 51·8% with DHA (P < 0·0001). AKs of all thicknesses were significantly more responsive to MAL-PDT. The patient CR rates at 3 months were 68% with MAL-PDT and 27% with DHA. At the 12-month examination, the number of patients with CR reduced to 37 with MAL-PDT and seven with DHA. Rating of cosmetic outcome was very good or excellent in the vast majority of patients with both treatments. The analysis of cost-effectiveness showed that the costs per patient with CR at 3 months and at 12 months are €566·7 and €1026·2, respectively, with MAL-PDT and €595·2 and €2295·6, respectively, with DHA. CONCLUSIONS: Efficacy, cosmetic outcome and patients' overall satisfaction with MAL-PDT are superior in comparison with DHA. MAL-PDT is more expensive but it is more cost-effective.

Comparison of five antimicrobial regimens for treatment of mild to moderate inflammatory facial acne vulgaris in the community: randomised controlled trial.

BACKGROUND: We investigated the efficacy and cost-effectiveness of five antimicrobial regimens for mild to moderate facial acne and whether propionibacterial antibiotic resistance affects treatment response. METHODS: In this randomised, observer-masked trial, 649 community participants were allocated one of five antibacterial regimens. Primary outcomes were patients' self-assessed improvement and reduction in inflamed lesions at 18 weeks. Analyses were by intention to treat. FINDINGS: Moderate or greater improvement at 18 weeks was reported in 72 (55%) of 131 participants assigned oral oxytetracycline plus topical placebo, 70 (54%) of 130 assigned oral minocycline plus topical placebo, 78 (60%) of 130 assigned topical benzoyl peroxide plus oral placebo, 84 (66%) of 127 assigned topical erythromycin and benzoyl peroxide in a combined formulation plus oral placebo, and 82 (63%) of 131 assigned topical erythromycin and benzoyl peroxide separately plus oral placebo. Most improvement occurred in the first 6 weeks. Treatment differences for the proportion of people with at least moderate improvement were: minocycline versus oxytetracycline -1.2% (unadjusted 95% CI -13.3 to 10.9); combined erythromycin and benzoyl peroxide versus oxytetracycline 11.1% (-0.7 to 22.9) and versus minocycline 12.3% (0.4 to 24.2); erythromycin and benzoyl peroxide separately versus combined formulation -3.5% (-15.2 to 8.2); benzoyl peroxide versus oxytetracycline 5.0% (-7.0 to 17.0), versus minocycline 6.2% (-5.8 to 18.2), and versus combined formulation -6.1% (-17.9 to 5.7). Benzoyl peroxide was the most cost-effective treatment. Efficacy of both tetracyclines was reduced by pre-existing tetracycline resistance. INTERPRETATION: Topical benzoyl peroxide and benzoyl peroxide/erythromycin combinations are similar in efficacy to oral oxytetracycline and minocycline and are not affected by propionibacterial antibiotic resistance.

Once-daily tazarotene 0.1 % gel versus once-daily tretinoin 0.1 % microsponge gel for the treatment of facial acne vulgaris: a double-blind randomized trial.

The efficacy and tolerability of tazarotene 0.1% gel and tretinoin 0.1% microsponge gel were evaluated in a multicenter, double-blind, randomized, parallel-group study in patients with mild-to-moderate inflammatory facial acne vulgaris. A total of 169 patients were randomized to once-daily applications of one of these topical retinoids for 12 weeks. Both agents were associated with significant reductions from baseline in the noninflammatory and inflammatory lesion counts. Tazarotene treatment was associated with a significantly greater incidence of treatment success (defined as > or = 50% global improvement [67% vs 49%; P=.03]) and significantly greater reductions in overall disease severity (36% vs 26%; P=.02) and noninflammatory lesion count (60% vs 38% at week 12; P=.02) than tretinoin microsponge treatment. Both drugs were well tolerated, with mean levels of dryness, burning, pruritus, erythema, and peeling generally being no more than trace throughout the study. There were no clinically significant between-group differences in these measures of tolerability. Two patients in each group (2%) discontinued because of treatment-related adverse events. The mean amount of medication applied by the patients was 0.28 g per application with tazarotene and 0.41 g per application with tretinoin microsponge, resulting in cost-effectiveness ratios of $81.45 per treatment success with tazarotene and $108.24 per treatment success with tretinoin microsponge. Tazarotene was observed to have greater efficacy and comparable tolerability and to be a cost-effective alternative to tretinoin 0.1% microsponge gel.

A multicenter, double-blind, randomized comparison study of the efficacy and tolerability of once-daily tazarotene 0.1% gel and adapalene 0.1% gel for the treatment of facial acne vulgaris.

The efficacy and tolerability of tazarotene 0.1% gel and adapalene 0.1% gel were compared in a multicenter, double-blind, randomized, parallel-group study in 145 patients with mild-to-moderate facial acne vulgaris. Both treatments were applied once daily in the evenings for up to 12 weeks. Compared with adapalene, treatment with tazarotene was associated with a significantly greater incidence of treatment success (> or = 50% global improvement) (78% vs 52%; P=.002) and significantly greater reductions in overall disease severity (P<.0001), noninflammatory lesion count (P<.0001), and inflammatory lesion count (P=.0002). In the early weeks of treatment, tazarotene was associated with transiently greater levels of burning, pruritus, erythema, and peeling compared with adapalene (P<.01). However, mean levels of these parameters were consistently less than mild in both treatment groups and, at the end of treatment, patients considered both treatments to be comparably well tolerated (the proportion of patients in each group who rated the comfort of their treated skin as comfortable or very comfortable was 76% with tazarotene and 69% with adapalene). Mean usage of study medication was 0.32 g per application of tazarotene and 0.42 g per application of adapalene, which resulted in cost-effectiveness ratios of $79.95 per treatment success for tazarotene and $107.88 per treatment success for adapalene. Sensitivity analyses suggest that these cost-effectiveness results are robust across a range of cost and efficacy assumptions. In conclusion, tazarotene 0.1% gel was more effective than adapalene 0.1% gel and was also a more cost-effective treatment option.