A randomized, controlled, comparative study to assess the efficacy and safety of Acne-Pro Gel in treatment of acne

Gods Own Store LLP A Amritpuri opp Iskcon Temple East of Kailash New Delhi India0 sites0 target enrollmentStarted: TBDLast updated: November 24, 2021

Overview

Phase: Phase 4
Status: Not yet recruiting
Sponsor: Gods Own Store LLP A Amritpuri opp Iskcon Temple East of Kailash New Delhi India

No summary available.

•1\.Participants must be adults, aged 18\-45 years old with mild to moderate facial acne with 10\-100 lesions.
•2\.Should have an acne grade of at least 2\.
•3\.Females Subjects must have a negative pregnancy test. Pregnant patients or individual with history of pregnancy will be excluded from the study.
•4\.Participants should be willing to sign a written consent for participation in the study and undergo a baseline interview.
•5\.Participants must be willing to apply the test product and return for assessment visits for evaluation.
•6\.Participants must agree that during the study they will refrain from taking any new herbal supplement and prescription or nonprescription medications treatment that has not been recommended by the study physician.
•7\. Participants must agree to take healthy diet and life style.

•1\.Participants with more than 2 acne nodules.
•2\.Single or married subjects who are pregnant or have borne children in past one year.
•3\.Participants with a current skin disease other than acne.
•4\.Participants with facial hair that may obscure acne lesions.
•5\.Participant with a history of Use of topical or systemic steroids OR topical or systemic antibiotics within the last 2 or 4 weeks, respectively; Use of topical acne treatments (eg. benzoyl peroxide, salicylates, retinoids) within the last 2 weeks OR Use of systemic retinoids within the past 6 months
•6\.Participant undergone procedures on the face such as peels, laser therapy or microdermabrasion within the past 4 weeks
•7\.Women of childbearing potential not using a reliable contraceptive method. Participants taking oral contraceptives must have been taking their current contraceptive for the previous 3 months and must agree to continue with it until study completion. Concurrent diseases which exclude the administration of therapy as outlined by the study protocol
•8\.Participant with a evidence of concurrent disease that exclude administration of therapy as outlined by the study protocol.
•9\.Participant with history or presence of Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study and/or likely to cause death within the study duration.
•10\.Subjects who, in the opinion of the investigator, abuse alcohol or drugs

Sponsor

Gods Own Store LLP A Amritpuri opp Iskcon Temple East of Kailash New Delhi India