Herbal Acne-Pro Gel in treatment of acne

Not Applicable

Not yet recruiting

• Conditions: Acne vulgaris, (2) ICD-10 Condition: L700||Acne vulgaris, (3) ICD-10 Condition: 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

Eligible participants screened in baselineinterview will be randomized into two groups to be treated with either the testproduct Acne-Pro or comparator. Thebaseline interview will collect demographic data and history of acne such asnumber of inflamed and non-inflamed facial lesions will be recorded. Level ofacne will be graded using a 5-point severity scale (0-4; 0 = clear skin;1=almost clear; 2= mild severity with few non inflamed lesions; 3=moderateseverity with many non-inflamed and some inflamed lesions; and 4= severe withmany inflamed lesions).Subjects will be evaluated at Day 7, Day 15 and at theend of one month (Day 30) (assessment visits) subsequent to the initiation oftreatment. Safety analyses will be done at each visit.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-11
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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.
• Participants must agree to take healthy diet and life style.

Exclusion Criteria

• 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:	Baseline Visit | (Day 0)Assessment Visit 1 | (Day 7 ±2 days)Assessment Visit 2 | (Day 15 ±2 days)Assessment Visit 3 | (Day 30 ±2 days)
1.Decrease in non-inflammatory lesion count from the baseline.	Baseline Visit | (Day 0)Assessment Visit 1 | (Day 7 ±2 days)Assessment Visit 2 | (Day 15 ±2 days)Assessment Visit 3 | (Day 30 ±2 days)
2.Decrease in inflammatory lesion count from the baseline.	Baseline Visit | (Day 0)Assessment Visit 1 | (Day 7 ±2 days)Assessment Visit 2 | (Day 15 ±2 days)Assessment Visit 3 | (Day 30 ±2 days)
3.Decrease in perceived facial oiliness.	Baseline Visit | (Day 0)Assessment Visit 1 | (Day 7 ±2 days)Assessment Visit 2 | (Day 15 ±2 days)Assessment Visit 3 | (Day 30 ±2 days)

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints comprise of the safety analyses	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)

Trial Locations

Locations (1)

Elite Aesthetic & Cosmetic Clinic; 🇮🇳 South, DELHI, India

Elite Aesthetic & Cosmetic Clinic

🇮🇳South, DELHI, India

Dr Shihiji Srivastava

Principal investigator

9205340090

drelite27@gmail.com