Irritation Potential of Meela Hair care Herbal Oil

Phase 2/3

Completed

Brief Summary: 24 adult healthy subjects will be selected for the study. The subjects selected for this study will be healthy females and males, aged between 18 and 55 years old. in which 12 will be female and 12 will be male subjects.The entire study procedure, patch application, patch reading and grading is detailed in the protocol and followed as per protocol. The patch applied to contain Finn’s chamber within which 2 drops of the test product will be filled in separate’s chambers.The patch is applied on the back or shoulder area of the subjects and will be in contact with the skin for 24 hours. If the subject experiences any allergic reactions, the patch can be removed within 24 hours and reported to Investigator immediately. The mean scores of erythema/dryness, wrinkles, oedema mean irritation index will be calculated on day 1,2,3 and 8.

Recruitment & Eligibility

Inclusion Criteria

Healthy subjects with healthy skin on the studied anatomic unit (free of eczema, wounds & any other inflammatory scar) 2.
Age group of 18 to 55 years, 12 male and 12 female subjects.
Compliance with the study procedures involved.

Exclusion Criteria

Exclusion criteria: 1.
Pregnant and lactating women 2.
Subjects with any other skin disorders.
Use of any other topical agents for any skin related conditions (at the site of application of patch) during the past 30 days.

Primary Outcome Measures

Name	Time	Method
Evaluation of mean scores of	Day 1,2,3 and 8
Erythema/dryness/wrinkles, Oedema and Mean irritation index	Day 1,2,3 and 8
Irritation Index	Day 1,2,3 and 8

Secondary Outcome Measures

Name	Time	Method
occurrence of any adverse effects	Day 1,2,3 and 8

Locations (1): Thirumalai Clinic and Raghavendra Diagnostic Centr
🇮🇳
Pondicherry, PONDICHERRY, India
Thirumalai Clinic and Raghavendra Diagnostic Centr
🇮🇳Pondicherry, PONDICHERRY, India
Dr Sakthi Balan
Principal investigator
9443627722
saheerose@gmail.com