Use of Intralesional Deoxycholic Acid for Antiretroviral Treatment Associated Lipohypertrophy: A Qualitative Open-Label Study of an Innovative Indication.

Background: With the advent of antiretroviral treatment (ART), human immunodeficiency virus/AIDS has become a chronic manageable disease. Though life expectancy has improved, it brings alongside effects of long-term medical treatment. One of the major side effects is body dysmorphism, which leads to esthetic problems. Problems of lipodystrophy (LDS), especially facial lipoatrophy as well as facial and upper back lipohypertrophy are perceived by patients as highly stigmatizing manifestations of their human immunodeficiency virus infection. It has been reported to affect mood and quality of life, as well as reduced adherence to antiretroviral medications. Patients feel discomfort while sleeping, dressing, and during day-to-day activities. Aim: The aim of this study was to test a relatively cost-effective and efficacious treatment modality for long-standing ART-associated lipohypertrophy of the submental fat and dorsocervical fat. Materials and Methods: This was a prospective open-label clinical study, in which 21 patients on regular ART with associated lipohypertrophy were enrolled in this open-label study. Deoxycholic acid (DCA) was given intralesionally once every 4-6 weeks. Patients were assessed for response, any adverse events, and patient satisfaction during every visit. Results: Intralesional DCA seems to be a promising treatment modality for long-standing ART-induced LDS with better cost-benefit in comparison with surgical interventions. Limitations: It was a small-sized sample that was studied. The lag time between starting the treatment and optimum results was long in comparison with liposuction. The result is better appreciated at the end of treatment rather than after every session implying that it has a cumulative effect. Neither pre- and post-ultrasonography nor metric documentation was done. Conclusions: Intralesional DCA seems to be a promising treatment modality for long-standing ART-induced LDS with better cost-benefit in comparison with surgical interventions.

An Open-Label Randomized Multicenter Study Assessing the Noninferiority of a Caffeine-Based Topical Liquid 0.2% versus Minoxidil 5% Solution in Male Androgenetic Alopecia.

BACKGROUND: Androgenetic alopecia is a condition with a high prevalence worldwide and affects both males and females. Currently, only 2 approved treatments exist: finasteride (males only) and minoxidil 2 or 5% solution (males and females). METHODS: We conducted a randomized, open-label, multicenter noninferiority study to determine whether a caffeine-based 0.2% topical liquid would be no less effective than minoxidil 5% solution in males (n = 210) with androgenetic alopecia. The primary end point was the percentage change in the proportion of anagen hairs from baseline to 6 months using a frontal and occipital trichogram. RESULTS: At 6 months, the group of the 5% minoxidil solution showed a mean improvement in anagen ratio of the trichogram of 11.68%, and the group of the 0.2% caffeine solution had an anagen improvement of 10.59%. The difference of mean values between both groups was 1.09%. The statistical analysis was performed and reported in accordance with the CONSORT Guidelines 2010 for reporting of noninferiority and equivalence randomized trials. CONCLUSION: A caffeine-based topical liquid should be considered as not inferior to minoxidil 5% solution in men with androgenetic alopecia.

Tretinoin Nanogel 0.025% Versus Conventional Gel 0.025% in Patients with Acne Vulgaris: A Randomized, Active Controlled, Multicentre, Parallel Group, Phase IV Clinical Trial.

BACKGROUND: Conventional topical tretinoin formulation is often associated with local adverse events. Nanogel formulation of tretinoin has good physical stability and enables good penetration of tretinoin into the pilo-sebaceous glands. AIM: The present study was conducted to assess the efficacy and safety of a nanogel formulation of tretinoin as compared to its conventional gel formulation in the treatment of acne vulgaris of the face. MATERIALS AND METHODS: This randomized, active controlled, multicentric, phase IV clinical trial evaluated the treatment of patients with acne vulgaris of the face by the two gel formulations locally applied once daily at night for 12 wk. Acne lesion counts (inflammatory, non-inflammatory & total) and severity grading were carried out on the monthly scheduled visits along with the tolerability assessments. RESULTS: A total of 207 patients were randomized in the study. Reductions in the total (72.9% vs. 65.0%; p = 0.03) and inflammatory (78.1% vs. 66.9%; p = 0.02) acne lesions were reported to be significantly greater with the nanogel formulation as compared to the conventional gel formulation. Local adverse events were significantly less (p = 0.04) in the nanogel group (13.3%) as compared to the conventional gel group (24.7%). Dryness was the most common adverse event reported in both the treatment groups while peeling of skin, burning sensation and photosensitivity were reported in patients using the conventional gel only. CONCLUSION: In the treatment of acne vulgaris of the face, tretinoin nanogel formulation appears to be more effective and better tolerated than the conventional gel formulation.