CDSCO Panel Recommends Phase IV Trial for Acne FDC Gel by Precise Biopharma
New Delhi: The Subject Expert Committee (SEC) under the Dermatology and Allergy division of the Central Drugs Standard Control Organisation (CDSCO) has recommended to conduct Phase IV clinical trial for a fixed-dose combination (FDC) topical gel developed by Precise Biopharma Pvt. Ltd.
The formulation combines Clindamycin Phosphate IP 1.2% w/w (equivalent to Clindamycin 1% w/w) and Hydrous Benzoyl Peroxide IP (equivalent to anhydrous Benzoyl Peroxide 3.75%), a combination widely used in dermatological therapy for acne.
As per the condition outlined in Form CT-23 dated 11.01.2024, the company was required to submit its Phase IV clinical trial protocol for regulatory review. The firm presented the protocol during the 6th meeting of the SEC (Dermatology & Allergy) held on June 11, 2025, at CDSCO Headquarters in New Delhi.
Following a detailed evaluation, the expert panel recommended to conduct Phase IV study. The committee emphasized that the trial results must be submitted to CDSCO for further review upon completion.
The FDC gel combines two active ingredients frequently prescribed for acne treatment:
Clindamycin, a lincosamide antibiotic that inhibits bacterial protein synthesis, and
Benzoyl Peroxide, a keratolytic and bactericidal agent known to reduce acne-causing bacteria and inflammation.
