Efficacy and safety of lactoferrin based cream (SiraciltTM acne) in the treatment of patients with mild to moderate acne vulgaris – a randomized, comparative and pilot study

Harsh J. Shah; Jacky K. Pariyani; Kalyani V. Shinde

doi:10.18203/2319-2003.ijbcp20253373

Authors

Harsh J. Shah Department of Medical Affairs, Frimline Private Limited (a subsidiary of La Renon Healthcare Pvt. Ltd.), Ahmedabad, Gujarat, India
Jacky K. Pariyani Department of Medical Affairs, Frimline Private Limited (a subsidiary of La Renon Healthcare Pvt. Ltd.), Ahmedabad, Gujarat, India
Kalyani V. Shinde Department of Medical Affairs, Frimline Private Limited (a subsidiary of La Renon Healthcare Pvt. Ltd.), Ahmedabad, Gujarat, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20253373

Keywords:

Acne vulgaris, Azelaic acid, Clindamycin, Lactoferrin, Niacinamide, Siracilt™

Abstract

Background: This pilot study was planned to evaluate the efficacy and safety of Siracilt™ Acne (lactoferrin, azelaic acid, and niacinamide) cream and compare it with azelaic acid cream and clindamycin gel in the treatment of patients with mild to moderate acne vulgaris.

Methods: This study was a randomized, open-label active controlled, parallel group clinical trial. A total of 80 patients with mild to moderate acne vulgaris [investigator global assessment (IGA) score, 2 or 3] were randomized to receive Siracilt™ Acne cream, azelaic acid 10% cream, azelaic acid 20% cream, and clindamycin 1% gel for 4 weeks. The primary endpoint was the proportion of patients who achieved treatment success (IGA score, 0 or 1 and/or at least a 2-point reduction in IGA score) after 4 weeks. Secondary efficacy endpoints included a percentage reduction of total lesions and a change in total, inflammatory, and non-inflammatory lesions after 4 weeks.

Results: After 4 weeks, the proportion of patients achieving treatment success in the Siracilt™ Acne group was 65%; while it was 0%, 10%, and 0% in azelaic acid 10%, azelaic acid 20%, and clindamycin 1% groups, respectively. The percentage reduction in the number of total acne lesions after 4 weeks was 62.1%, 27.2%, 46.6%, and 25.1% with Siracilt™ Acne cream, azelaic acid 10% cream, azelaic acid 20% cream, and clindamycin 1% gel, respectively. Similar results were observed for change in total, inflammatory, and non-inflammatory lesions after 4 weeks. Overall, the treatments were safe and well tolerated.

Conclusions: In conclusion, Siracilt™ Acne cream demonstrated superior efficacy compared to azelaic acid and clindamycin in the treatment of mild to moderate acne vulgaris.

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