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

Not yet recruiting

• Conditions: Having Acne Vulgaris

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

Brief Summary

Thisis an open label, randomized, multicentre, parallel group, two arminvestigator-initiated study. Subjects suffering from mild to severe acne andmeeting all inclusion and no exclusion criteria after signing a writteninformed consent will be enrolled in the study. After passing the eligibilitycriteria, subjects will be randomized into 2 treatment arms (50:50) to receiveeither Nixiyax plus standard of care or standard of care alone.

Thesubject will arrive at the study site in a fasted state and blood samples willbe collected for laboratory assessment (cortisol level and safety assessment).Post blood sample collection, acne severity will be assessed by theInvestigators Global Assessment (IGA) scoring and lesion count. Photograph ofthe lesion areas on the face will be taken for documentation.

Stress assessment will be performed by administering different questionnaires.Theimpact of stress and acne on the quality of life of the subjects will beassessed with Dermatology Life Quality Index (DLQI) questionnaire.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-01-17
• Study Start: 2019-01-21

Recruitment & Eligibility

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

Inclusion Criteria

• 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
2. Changes in Serum Cortisol Level	Day 0, Day 42, Day 84
1. changes in stress assessment questionnaire scores	Day 0, Day 42, Day 84

Secondary Outcome Measures

Name	Time	Method
changes in	1. Acne lesion count

Trial Locations

Locations (2)

Dr. Amit Kerure Skin Clinic; 🇮🇳 Thane, MAHARASHTRA, India

Sparkle Skin and Aesthetic Center; 🇮🇳 Thane, MAHARASHTRA, India

Dr. Amit Kerure Skin Clinic

🇮🇳Thane, MAHARASHTRA, India

Dr Amit Shivaji Kerure

Principal investigator

9619766139

amitkerure@gmail.com