A comparative clinical study to evaluate the efficacy of Nixiyax on mental wellbeing in subjects with acne problems

Not Applicable

• Registration Number: CTRI/2019/01/017172
• Lead Sponsor: Curatio Healthcare I Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Must have mild to severe acne Vulgaris

2. Must be willing and able to give informed Consent.

3.Female subjects Non Pregnant and Non lactating

Exclusion Criteria

1Known conditions that may interfere with the evaluation of acne vulgaris. Such conditions include but are not limited to the following: rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne or folliculitis; carcinoid syndrome; squamous cell carcinoma; mastocytosis; acneiform eruptions caused by make-up or medication; bacterial folliculitis; facial psoriasis; and facial eczema.

2Subjects allergic to herbal products or any component of the study product

3Subjects who have been treated topical or oral corticosteroids within 14 days prior to baseline

4History of uncontrolled disease or immune deficient disorder

5Any feature in the test areas (face) that according to the investigator may influence the results, for example, but not limited to moles, tattoos, scars, irritated skin, scratches, cuts and excess hair

6Known HIV or Hepatitis B positive or any other immuno-compromised state

7Female subjects who are pregnant, nursing or planning to become pregnant during study participation

8Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study

9Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. changes in stress assessment questionnaire scores <br/ ><br>2. Changes in Serum Cortisol LevelTimepoint: Day 0, Day 42, Day 84

Secondary Outcome Measures

Name	Time	Method
changes in <br/ ><br>1. Acne lesion count <br/ ><br>2. IGA acne severity <br/ ><br>3. Dermatology Life Quality Index (DLQI) scoresTimepoint: Day 0. Day 42, Day 84