[HTML][HTML] Safety and efficacy of adapalene gel 0.1% in acne vulgaris: Results of a post-marketing surveillance study
SH Percy - Indian Journal of Dermatology, Venereology and …, 2003 - ijdvl.com
SH Percy
Indian Journal of Dermatology, Venereology and Leprology, 2003•ijdvl.comIntroduction: Adapalene is a novel retinoid indicated for the topical treatment of acne
vulgaris. The drug was introduced in India in 2001. Aims: A post-marketing surveillance
study was conducted to assess the safety and efficacy of adapalene gel 0.1% when used as
monotherapy or in combination with other anti-acne agents in Indian patients of acne
vulgaris. Material and Methods: A 12-week, multicentre, open-label, non-comparative study
involving 571 patients from 21 centers across India was conducted between January and …
vulgaris. The drug was introduced in India in 2001. Aims: A post-marketing surveillance
study was conducted to assess the safety and efficacy of adapalene gel 0.1% when used as
monotherapy or in combination with other anti-acne agents in Indian patients of acne
vulgaris. Material and Methods: A 12-week, multicentre, open-label, non-comparative study
involving 571 patients from 21 centers across India was conducted between January and …
Introduction
Adapalene is a novel retinoid indicated for the topical treatment of acne vulgaris. The drug was introduced in India in 2001.
Aims
A post-marketing surveillance study was conducted to assess the safety and efficacy of adapalene gel 0.1% when used as monotherapy or in combination with other anti-acne agents in Indian patients of acne vulgaris.
Material and Methods
A 12-week, multicentre, open-label, non-comparative study involving 571 patients from 21 centers across India was conducted between January and September of 2002. Concomitant prescription of other anti-acne drugs was permitted, if needed.
Results
Of the 571 patients, 441 completed the treatment as per protocol. At the end of therapy, 96.3% of patients showed an improvement in their acne from baseline, with greater than 75% improvement seen in two-thirds of patients. Adverse events were reported in 24% of the patients, none of which were serious. The tolerability of therapy was rated as excellent/good in 81% of patients by physicians and in 78% by the patients.
Conclusion
Adapalene gel 0.1% is a safe and effective topical agent in the treatment of mild to moderate acne vulgaris in Indian patients. It may be safely combined with other topical and oral anti-acne agents.
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