A Randomized, Double-blinded, Placebo Controlled, Monocentric Study to Evaluate the Anti-ageing and Skin Brightening Benefit of the Test Product in Healthy Female Subjects

Launched by RATAN K. CHAUDHURI · Feb 17, 2020

Keywords

ClinConnect Summary

Every day the cells of the outer layer of skin die off, shed, and regenerate. When young, skin cells turn over quickly, but that turnover rate begins to slow with age, beginning as early as twenties. As a result, skin loses its luster and begins to look dull. Aging caused by the genes is inherited and is called intrinsic (internal) aging. The other type of aging is known as extrinsic (external) aging and is caused by environmental factors, such as exposure to the sun's rays.

Skin ageing is mainly characterized by -

1. Decrease in thickness, firmness \& elasticity of skin which results in ...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female adult subjects in general good health as determined from a recent medical history, general physical examination, dermatological assessment.
• • Subjects in the age group of 35-50 years (both ages inclusive).
• • Subject with Fitzpatrick skin types III to V (ITA to be recorded at forehead and flexor forearm)
• • Subjects with chronic pollution exposure in past 5 years based on pollution questionnaire (Refer annexure 1)
• • Subjects with normal to dry skin type (corneometer reading upto 35)
• • Subjects with mild to moderate fine lines and wrinkles in periorbital area (Crow's feet-under eye) \& forehead (Refer annexure 3 for photonumerical scale)
• • Subjects with minimum one spot with width ≥3 mm
• • Subjects with chronic pollution exposure in past 5 years based on pollution questionnaire (Refer annexure 1)
• • Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.
• • Subject who agrees not to use any other product/treatment/home remedy/ except the provided product on their face during the study period other than the test product.
• • Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period.
• • Subjects who agree not to expose to excessive sun light. (Sun exposure not more than half an hour daily and during that time use of umbrella to cover face).
• • Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
• • Subjects willing to abide by and comply with the study protocol.
• Exclusion Criteria:
• • Subject with any other signs of significant local irritation or skin disease.
• • Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data.
• • Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year.
• • Subjects who do not agree to remove all jewellery on/around face (e.g., necklace, earrings, if possible nose ring), during VISIA imaging.
• • Subjects having hair style which covers almost the entire forehead
• • Subjects undergoing any treatment of any skin condition on their face/forearm.
• • Subjects not willing to discontinue other topical facial products.
• • Subject allergic or sensitive to bar cleansing products, cosmetics, creams/lotions, artificial jewellery or anything else.
• • Pregnant women (as confirmed by UPT) and lactating women
• • Subjects on any medical treatment either systemic/topical in the past 1 month or currently taking medication including food supplements.
• • Subjects with skin allergy history or atopic dermatitis or psoriasis
• • Subjects who have participated in any other clinical trial in the last 3 months.
• • Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study
• • Subjects that was treated with Botox/filler /bio stimulatory molecules injection