CTRI/2023/04/051261
Not yet recruiting
未知
Efficacy Evaluation of Cosmetic Formulation in Conferring Skin Tan Lightening Benefits in Healthy Human Participants.
ITC Life Sciences Technology Centre0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ITC Life Sciences Technology Centre
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Volunteer in the age group of 19 to 50 years
- •2· Volunteers with visible skin Tan on face, at least 2 shade darker than a Sun protected upper volar arm
- •3· Volunteers with a L value in the range of 40 to 60 on cheeks, and L value at least 3 units higher than cheeks on volar upper arm/ bicep area (C1\).
- •4· Participants with varied skin type i.e. normal, dry, oily, combination and sensitive skin in nearly equal ratio
- •5· At least 15 volunteers with few solar lentigines on face
- •6· At least 35 volunteers with Persistent Tan (atleast 4weeks old)
- •7· At least 35 volunteers with a recent tan (Developed on the day of baseline visit)
- •8· Persistent Tan since (at least 4weeks) and recent tan (Developed on the day of baseline visit) in each case
- •9· Volunteers willing to abide by the study protocol and refrain from using any product other than the provided Investigational product during the study course.
- •10· Volunteers willing to visit the site for periodic assessments on the scheduled dates.
Exclusion Criteria
- •1\. Pregnant or lactating women
- •2· Participants undergoing treatment for Seborrhoea, Acne, Dermatitis, skin lightening/ any other cosmetic/ dermatologic skin condition on face
- •3· Participants with pre\-existing systemic disease requiring long\-term medication (self\-declaration)
- •4· Participants with genetic and endocrinal disorders \[ self\-disclosure]
- •5· Participants with drug induced acne \[ self\-disclosure]
- •6· Participants with any other signs of significant local irritation or skin disease.
- •7· Participants on oral hormonal treatment or oral medications (e.g., steroids, anti\-oxidant) for eight weeks prior to the study which will compromise the study.
- •8· Participants who may change personal nutrition habits and other habits as per investigatorâ??s discretion.
- •9· Participants who have participated in a similar investigation or any other clinical product evaluation test in the past four weeks
- •10· Participants under the influence of alcohol and/or drugs as well as addiction.
Outcomes
Primary Outcomes
Not specified
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