Sun Pharmaceutical Industries Limited ((IN:SUNPHARMA)) announced an update on their ongoing clinical study.
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Sun Pharmaceutical Industries Limited is conducting a study titled ‘Randomized, Multi-Center, Evaluator-Blind, Vehicle-Controlled Study to Evaluate Efficacy and Safety of Reformulated Levulan Kerastick Plus Photodynamic Therapy (PDT) for Field-Directed Treatment in Patients With Actinic Keratosis (AK) of Face and (Bald) Scalp.’ The study aims to assess the efficacy and safety of a reformulated version of Levulan Kerastick combined with photodynamic therapy for treating actinic keratosis on the face and scalp. This study is significant as it targets a common precancerous skin condition, potentially offering a more effective treatment option.
The intervention being tested is the Reformulated Levulan Kerastick, containing aminolevulinic acid hydrochloride (ALA HCl) 20%, used in combination with a Blue Light Photodynamic Therapy Illuminator device. This treatment is designed to target and clear actinic keratosis lesions.
The study is designed as a Phase 3, randomized, multi-center trial with a parallel intervention model. It employs triple masking, meaning the participant, investigator, and outcomes assessor are blinded to the treatment assignments. The primary purpose of the study is treatment-focused.
The study is set to begin on August 20, 2025, with primary completion and estimated completion dates yet to be announced. The last update was submitted on the same date, indicating the study is in its initial stages.
The potential market implications of this study are significant for Sun Pharmaceutical Industries. A successful outcome could enhance the company’s product portfolio, potentially boosting stock performance and investor confidence. This development could also impact competitors in the dermatology treatment sector, as new, effective treatments for actinic keratosis are in demand.
The study is ongoing, with further details available on the ClinicalTrials portal.