Clinical study on Anti-acne face pack in pimples

Phase 2

Completed

• Conditions: Health Condition 1: L700- Acne vulgaris

• Registration Number: CTRI/2022/07/044012
• Lead Sponsor: amaskar Ayurved Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-09-21
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

1.Subjects suffering from acne vulgaris [mild and moderate as per Global Acne Grading System (GAGS)] as diagnosed by physician or dermatologist

2.Subjects willing to follow study instructions given by the investigator

Exclusion Criteria

1.Subjects with known pre-existing systemic disease necessitating long-term medications.

2.Subjects with known current endocrinal disorders.

3.Subjects taking treatment for menstrual disorders

4.Subjects having systemic treatment for acne vulgaris.

5.Subjects on any other investigational products within 1 month prior to randomization;

6.Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer, kidney failure.

7.Pregnant and lactating women

8.Known hypersensitivity to any of the ingredients of Anti-acne Face Pack

9.Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in total number of inflammatory acne lesions on faceTimepoint: Screening / Baseline visit (Day 0), visit 1 (Day 15), visit 2 (Day 30), visit 3 (Day 45)

Secondary Outcome Measures

Name	Time	Method
1.Changes in total numbers of non-inflammatory acne lesions <br/ ><br>2.Changes in total lesion count (inflammatory and non-inflammatory) <br/ ><br>3.Difference in number of comedones (blackheads and whiteheads) <br/ ><br>4.Changes in severity of acne vulgaris <br/ ><br>5.Changes in signs and symptoms of acne vulgaris <br/ ><br>6.Changes in acne scarring <br/ ><br>7.Changes in skin lightening effect <br/ ><br>8.Changes in post acne dark spots <br/ ><br>9.Global assessment for overall change by participants and by physician <br/ ><br>10.Assessment of post treatment tolerability of study drug by participants and physician. <br/ ><br>11.Assessment of adverse events/adverse drug reactions including vitals <br/ ><br>Timepoint: Screening / Baseline visit (Day 0), visit 1 (Day 15), visit 2 (Day 30), visit 3 (Day 45)