CTRI/2017/12/011027
Completed
Phase 2
To evaluate the efficacy of the cream formulation in reducing skin wrinkles, increasing skin firmness, smoothness and hydration.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dabur India Ltd
- Enrollment
- 32
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.subjects in generally good health
- •2\.Subjects in the age group of 30\-50 years.
- •3\.Subjects should have minimum number of fine lines, mild to moderate.
- •4\.Subjects having a wrinkle and five volunteers with deep wrinkles will be selected for visiometer.
- •5\.Must have at least 2 hyperpigmentation lesions (freckles, lentigen, periorbital melanosis) each at least 3mm on the face. Subjects who exhibit moderate hyperpigmentation with a score of 3 but no greater than 4 (see scale in section 7\.3\.D.1\).
- •6\.Subject has not participated in a similar investigation in the past four weeks.
- •7\.Subjects have not used a similar product for the last four weeks.
- •8\.Subjects willing to give a written informed consent and come for regular follow.
Exclusion Criteria
- •1\.Subjects with known allergies or sensitivities to cosmetic products, toiletries or its components like fragrances, preservatives, hydroquinone, vitamin C, Niacin amide, retinol, soy etc.
- •2\.Currently or has been using topical retinoids, alpha\-hydroxy and/or beta\-hydroxy acids, hydroquinone or any whitening/Fairness preparation in any form (cleanser, toner, facial lotion, cream or soaps) within the last 1 month.
- •3\. Currently or has been undergoing dermatologist facial treatments or procedures within the last 1 month.
- •4\.Currently or has been involved in another facial skin care clinical investigation within the last 3 months.
- •5\.Subjects who have pre\-existing or dormant facial dermatologic conditions (e.g., psoriasis, rosacea, rashes, eczema, many and/or severe excoriations etc.) that could interfere with the outcome of the study as determined by the investigator.
- •6\.Subjects with excessive facial hair or scars (including acne scars), which could interfere with expert grader and/or instrumental evaluations.
- •7\.Subjects having melasma and severe photo damage.
- •8\.Subjects who are nursing as determined by the investigator interview during screening or pregnant as determined by the Urine pregnancy testing after screening.
- •9\.Subjects viewed by the investigator as not being able to complete the study.
Outcomes
Primary Outcomes
Not specified
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