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Safety & Efficacy assessment of skin care formulation

The objective of this study will be to evaluate efficacy of skin care formulation in terms of reduction in appearance of fine lines and wrinkles, density of dark spots, improvement in skin moisturization, skin firmness on healthy female subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048271
Enrollment
36
Registered
2022-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: BALAAYAH BLACK GRAM BRIGHT BODY BOOSTER(T6-0422):Product A: Product will be applied on the whole face, neck and upper arms, once in a day in morning for the period of 60 days Control In

Sponsors

Transformative Learning Solution Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Indian Female subjects 2)Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup) 3)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) 4)Having crows feet wrinkles, fine lines of grade 2 - 4 & Dark spots 5)Having loose skin(face, Neck and upper arms)

Exclusion criteria

Exclusion criteria: 1 Female subjects who are pregnant (determined by Urine pregnancy test) or breastfeeding or having stopped to breastfeed in the past three months 2 Having refused to give her assent by not signing the consent form 3 Taking part in another study liable to interfere with this study 4 Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 5 Having a progressive asthma (either under treatment or last fit in the last 2 years) 6 Being epileptic. 7 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8 Having cutaneous hypersensitivity 9 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 10 Having known allergy to any of the Ingredient of the Test Product 11 Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 12 Having consumed caffeine-based products (coffee, cola, tea …), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements 13 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 14 Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit 15 Having applied a cosmetic product (included make-up) or skin care product on the studied areas on the day of the study (only face cleaned with water is accepted) 16 Refusing to follow the restrictions below during the study:Do not take part in any family planning activities leading to pregnancy and breastfeeding, Do not take part in another study liable to interfere with this study, Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol), Do not consume any caffeine-based products (coffee, cola, tea …), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements, Do not change her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit, During the study: Do not use other cosmetic products or skin care products other than the tested products to the studied areas. (only usual cleanser/soap is accepted), The day of the measurements : No test product must be used (only test site cleaned with water is accepted) 17 Having started, changed or stopped a Hormone Replacement Therapy in the past 6 months. 18 Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months. 19 Having taken a Dehydroepiandrosterone based treatment in the previous 6 months. 20 Having applied products with an anti-wrinkle action particularly firming products (Retinoic acid, retinol, retinaldehyde, Alpha Hydroxy Acid….) in the 2 weeks preceding the start of the study. 21 Having made injections of anti-wrinkle products (collagen, hyaluronic acid, botulinic toxin…) in the previous 12 months. 22 Having undergone techniques with aesthetic aim (chemical peel, mechanical dermabrasion, laser, pulsed flash

Design outcomes

Primary

MeasureTime frame
Reduction in appearance of fine lines & wrinkles, Deansity of dark spots, improvement in skin moisturization,Skin firmnessTimepoint: Baseline, 15 Days, 28 Days,45 Days, 60 Days

Secondary

MeasureTime frame
Skin safety, Improvement in skin water barrier, reduction in circumference of upper armTimepoint: Baseline, 15 Days, 28 Days,45 Days, 60 Days

Countries

India

Contacts

Public ContactDr Mohit Lalvani

Transformative Learning Solution Pvt. Ltd.

satyendra.kumar@transformative.in9891253516

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026