Efficacy and safety of a nano-emulsion gel formulation of adapalene 0.1% and clindamycin 1% combination in acne vulgaris: A randomized, open label, active-controlled, multicentric, phase IV clinical trial.

Background: Acne vulgaris is a very common skin disease with a significant detrimental effect on the quality of life of the patients. Aims: To assess the comparative efficacy and safety of a nano-emulsion gel formulation of adapalene and clindamycin combination with its conventional formulation in the treatment of acne vulgaris of the face. It was a prospective, randomized, open label, active-controlled, multicentric, clinical trial. Methods: Eligible patients suffering from acne vulgaris of the face were randomized to receive once-daily treatment with a nano-emulsion gel or conventional gel formulation of adapalene 0.1% and clindamycin (as phosphate) 1% combination for 12 weeks. Total, inflammatory and noninflammatory lesion counts, with grading of acne severity were carried out on a monthly basis. Safety assessments were done to determine the comparative local and systemic tolerability. Two-tailed significance testing was carried out with appropriate statistical tests, and P-values < 0.05 were considered as significant. Results: 209/212 patients enrolled in the study were eligible for efficacy and safety assessments in both nano-emulsion gel (118/119 patients) and conventional gel (91/93 patients) groups. Significantly better reductions in total (79.7% vs. 62.7%), inflammatory (88.7% vs. 71.4%) and noninflammatory (74.9% vs. 58.4%) lesions were reported with the nano-emulsion gel as compared to the conventional gel (P < 0.001 for all). Mean acne severity score also reduced significantly more with the nano-emulsion formulation (1.9 ± 0.9 vs. 1.4 ± 1.0; P < 0.001) than the comparator. Significantly lower incidence and lesser intensity of adverse events like local irritation (4.2% vs. 19.8%; P < 0.05) and erythema (0.8% vs. 9.9%; P < 0.05) were recorded with the nano-emulsion gel. Conclusions: The nano-emulsion gel formulation of adapalene and clindamycin combination appears to be more efficacious and better tolerated than the conventional formulation for the treatment of acne vulgaris in Indian patients. Further studies can elucidate the comparative treatment benefits of this nano-emulsion gel formulation.

A study to evaluate the efficacy and safety of hydrocortisone aceponate 0.127% lipophilic cream in steroid responsive dermatoses in Indian patients.

Background: Topical corticosteroids (CSs) are the mainstay of therapy in various steroid responsive dermatoses. Newer CSs are more efficacious and safer than the older ones. There is no published data on the efficacy and safety of a new steroid hydrocortisone aceponate in the Indian population. Aim: To evaluate the efficacy and safety of hydrocortisone aceponate (0.127%) lipophilic cream in the treatment of steroid responsive dermatoses in Indian patients. Methods: Four hundred and fifteen patients with clinically diagnosed steroid responsive dermatoses enrolled in this study. They were advised to apply hydrocortisone aceponate (0.127%) lipophilic cream as a thin film to all the affected areas twice daily. Cleansing was done prior to the application with either soap-free cleanser or soap (that would not affect the study result). Use of oral antihistamines and/or antibiotics was permissible. However, other oral/topical steroid use was not permitted during the study. Patients were evaluated at day 0 and at day 21. Data were recorded regarding clinical improvement and side-effects, if any. They were then analyzed to determine the efficacy and safety of the cream. Results: Physician's global evaluation of therapy showed that lesions were cleared in 82 (22.10%), excellent result in 200 (53.91%), good result in 72 (19.41%), fair response in 15 (4.04%) and no change in 2 (0.54%) patients. There was no history of exacerbation in any patient. Conclusion: The study showed that hydrocortisone aceponate (0.127%) lipophilic cream is an effective therapeutic agent with a very good safety profile in various steroid responsive dermatoses in the Indian patient population.

Linear scleroderma following Blaschko's lines.

Blaschko's lines form a pattern, which many diseases are found to follow, but linear scleroderma following Blaschko's lines is a controversial entity rarely reported in the literature. A 24-year-old man presented with multiple linear, atrophic, hyperpigmented lesions punctuated by areas of depigmentations on the left half of the trunk distributed on the anterior, lateral and posterior aspects. The lesions were distributed in a typical S-shaped line. Antinuclear antibody and antihistone antibody tests were negative. Histopathological examination of the skin from the affected area showed features suggestive of scleroderma. Here, we present a case of linear scleroderma following Blaschko's lines in a male patient--an entity reported only three times so far.

Simultaneous occurrence of disseminated superficial, linear and hypertrophic verrucous forms of porokeratosis in a child.

Porokeratosis is a genodermatosis characterized by abnormal epidermal keratinization with the histological feature of cornoid lamella. There are many clinical variants, but two or more of these variants rarely occur in a single patient. This variation in clinical presentation may be due to the different phenotypic expression of a common genetic abnormality or may be the consequence of abnormalities in closely linked genetic loci or genes. Here we report about a child who showed simultaneous occurrence of disseminated, linear and hypertrophic verrucous lesions of porokeratosis. He also had genital lesions, reported uncommonly in the medical literature.