A Clinical study to evaluate the efficacy of Investigational product for the percentage reduction of lesions in patients with Acne vulgaris

Not Applicable

• Conditions: Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue

• Registration Number: CTRI/2018/09/015735
• Lead Sponsor: Atrimed Pharmaceuticals Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-11-26
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Age group 11 yrs. and 30 yrs.

2. Both genders

3. Patients with inflammatory and non-inflammatory papules, open and closed comedones with few pustules present over the skin.

4. AGSS score more than 1

5. Count lesion of more than 10

6. Lesion to be present for not less than 3 months (recurrent lesions are included)

7. Able to give informed consent. For patients younger than 18 years old, representatives (parents/guardians) are required to provide informed consent and the same will be documented.

Exclusion Criteria

1. Subjects on any other medication or cosmetics

2. Subjects using other anti-acne medications in the last 30 days before study

3. Patients with history of allergy to topical antibiotics

4. Pregnant women, those who may be pregnant, lactating women, and women who hope to become pregnant during the study period

5. Patients who had participated in other clinical studies within 3 months of the start of the study

6. Subjects who have any clinically significant allergic disease at the time of first examination or unwilling to enter into the study because of recent drug allergy.

7. History or presence of any debilitating disease like cancer, RA, TB etc.

8. Patients on OCP, antibiotics.

9. Patients with cystic acne and acne rosacea.

10. Patients on MAOI, ant- epileptics treatment, lithium.

11. PCOD / Underlying endocrine disease.

12. Patients with nodulocystic acne and acne fulminans.

13. Patients on steroids and ATT.

Study & Design

• Study Type: Interventional
• Study Design: Not specified