To study the effect and safety of an Anti-acne cream
- Conditions
- Healthy human volunteers suffering from acne.
- Registration Number
- CTRI/2022/09/045553
- Lead Sponsor
- PhytoMyco Research Pvt Ltd
- Brief Summary
Acne vulgaris (commonly called acne) is a common human skin problem, characterized by areas of skin with multiple non inflammatory follicular papules or comedones and by inflammatory papules, pustules, and nodules in its more severe forms. Propionibacterium acnes is the principal organism associated with inflammatory acne lesions. Acne is caused by the combination of too much sebum and a buildup of dead skin cells.
Acne vulgaris mostly affects the areas of skin with the densest population of sebaceous follicles; these areas include the face, the upper part of the chest, and the back. Acne occurs most commonly during adolescence, affecting more than 96% of teenagers, and frequently continues into adulthood.
Acne can have a significant physical, emotional, and social impact on an individual. Today there are many agents being used for relief from acne.
The product, **CLEARICA®****ANTI-ACNE CREAM,** is claimed to have anti acne effect, and this will be evaluated during the course of this study
Result: The study was completed with 33 complete cases and no adverse events.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
- Voluntary men and women between 16 and 30 years of age (approximately equal number).
- Having mild to moderate active acne or Non-cystic acne.
- Not on any treatment for acne.
- Accepting not to use products with the same end benefit during the entire study duration.
- Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
- Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.
- 1.Pregnancy by history and lactating women.
- Premenstrual women and women on oral contraceptives.
- Skin allergy antecedents or atopic subject.
- Hypersensitivity to any cosmetic product, raw material.
- PCOD, hirsutism, any hormonal issues etc by history or clinical examination.
- For whom the Investigator considers that he/she will not be compliant with study procedures.
- Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
- Participants on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
- Participant in an exclusion period or already participating in another similar cosmetic or therapeutic trial as identified during screening on visit 1 (V1).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of Acne lesions and redness by Clinical evaluation, Instrumentation and Self evaluation. Day 0, 72 hours, Day 7, Day 21
- Secondary Outcome Measures
Name Time Method Evaluation of tolerance of the test product Day 0, 72 hours, Day 7, Day 21
Trial Locations
- Locations (1)
C.L.A.I.M.S. Pvt. Ltd.
🇮🇳Mumbai, MAHARASHTRA, India
C.L.A.I.M.S. Pvt. Ltd.🇮🇳Mumbai, MAHARASHTRA, IndiaDr Rajiv JoshiPrincipal investigator02266758851rsjdrs@gmail.com