Safety study of Acne Recovery Lotion

Completed

• Conditions: No disease, healthy, skin type III to V.

• Registration Number: CTRI/2021/04/032787
• Lead Sponsor: NIKKOL GROUP COSMOS TECHNICAL CENTER CO LTD

Brief Summary

The aim of the study is to assess the irritancy of cosmetic products on human skin.



The protocol of this study is as per BIS guidelines, IS 4011 : 2018 , where 24 adult volunteers ( 12 male and 12 female ) participate in the study after meeting the Inclusion and Exclusion criteria.



Require quantity of Investigational Products along with positive & negative control taken on Finn chambers and same will apply on the upper back of volunteers.

For Soaps, the patch type is occluded and for Deodorants, patch type is Semi-occluded.



Finn chambers will be removed after 24 hours of patch application and reading will be taken after 24 hours of patch removal.



As per BIS directives, readings in term of erythema and oedema noted by PI in accordance with Draize scale.



The combined mean score upto 2.0 / 8.0 will mean that product is non-irritating.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-15
• Study Completion: 2021-05-31
• Last Update Posted: 2021-06-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Phototype III to V.
• Healthy skin on test area.
• having signed a consent form able to read and write valid id prrof.
• urine test negative for women.

Exclusion Criteria

• 1.Pregnant/nursing mothers.
• Scars, excessive terminal hair or tattoo on the studied area.
• Henna tattoo anywhere on the body (in case of studies involving hair dyes).
• Dermatological infection/pathology on the level of studied area.
• Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye).
• Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
• Chronic illness which may influence the outcome of the study.
• Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
• Subjects in an exclusion period or participating in another food or cosmetic or therapeutic trial.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of skin irritation potential ( Occurence of Erythema and Oedema ) w.r.t. Investigational Products at 4th day.	4th day

Secondary Outcome Measures

Name	Time	Method
To Check Contact Hypersensitivity as per BIS 4011 : 2018 directives	at 4th day

Trial Locations

Locations (1)

Dr. Joshis Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Dr. Joshis Clinic

🇮🇳Mumbai, MAHARASHTRA, India

Dr Sudhir Medhekar

Principal investigator

9820321430

sudhir.medhekar@gmail.com