To evaluate the efficacy of antiageing cream.
- Conditions
- Subjects in generally good health condition
- Registration Number
- CTRI/2017/12/011027
- Lead Sponsor
- Dabur India Ltd
- Brief Summary
Study was designed to test the safety & efficacy of topical antiageing product provided by Dabur India Limited on healthy human subjects. 35 subjects (17 male & 18 female) were enrolled in the study, and 32 subjects ( 14 male & 18 female) completed the study. The study was conducted over a period of approximately 84 days for each subject. the evaluation was done by dermatologist , subject evaluation and by instrument (cutometer, visiometer, corneometer, visioscan, mexameter, chromameter).
The product need to use on daily twice on clean face and observation taken by subject, dermatologist & instrument at all the visits.
The results of the study showed that the formulation has the antiageing potential, the product improves the skin elasticity , firmness and reduce the wrinkles on face and the test product was also found to be safe in all the subjects during the study period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 35
- 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.
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of the anti ageing cream in reducing skin wrinkles, hyperpigmentation and increasing skin firmness, smoothness and hydration n repetitive usage on healthy human subjects Day 1, Day 2, Week 2, Week 4, Week 8 and Week 12
- Secondary Outcome Measures
Name Time Method Safety of the subject throughout the study Day 1, Day 2, Week 2, Week 4, Week 8 and Week 12
Trial Locations
- Locations (1)
Kelkar Education Trust, Scientific Research Centre
🇮🇳Mumbai, MAHARASHTRA, India
Kelkar Education Trust, Scientific Research Centre🇮🇳Mumbai, MAHARASHTRA, IndiaUma AyachitPrincipal investigator022-25639644uma@kelkarcosmetology.com