Herbal Acne-Pro Gel in treatment of acne
- Conditions
- Health Condition 1: L700- Acne vulgarisHealth Condition 2: L700- Acne vulgarisHealth Condition 3: L709- Acne, unspecified
- Registration Number
- CTRI/2018/10/016050
- Lead Sponsor
- Gods Own Store LLP A Amritpuri opp Iskcon Temple East of Kailash New Delhi India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
4.Patients reporting use of prescription or non-prescription drugs that has not been pre-approved by the study physician.
5.Participant with known allergies to the main components of the test or comparator product.
6.Participation in another clinical trial or taking an investigational product in the past three months
7.Any participant who is not able to give informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoints comprise of various criteria measured for defining efficacy of the treatment. Criteria for efficacy are: <br/ ><br>1.Decrease in non-inflammatory lesion count from the baseline. <br/ ><br>2.Decrease in inflammatory lesion count from the baseline. <br/ ><br>3.Decrease in perceived facial oiliness. <br/ ><br>Timepoint: Baseline Visit <br/ ><br>(Day 0)Assessment Visit 1 <br/ ><br>(Day 7 ±2 days)Assessment Visit 2 <br/ ><br>(Day 15 ±2 days)Assessment Visit 3 <br/ ><br>(Day 30 ±2 days) <br/ ><br>
- Secondary Outcome Measures
Name Time Method The secondary endpoints comprise of the safety analyses <br/ ><br>Mean tolerability score Evaluated as the average of the following Parameters: Erythema, scaling, peeling, burning, induration and dryness scored using a 5-point scale (0 None, 1 Minimal, 2 Mild, 3 Moderate, 4 Severe) <br/ ><br> Local or systemic adverse events will be recorded including type of reaction and severity using a 5 point scale where 0 none and 4 severe. <br/ ><br>Timepoint: Day 0, Day 7, Day 15 and Day 30