Safety & Efficacy assessment of skin care formulation

Completed

• Conditions: The subjects selected for this study are healthy females aged between 35 and 55 years, having crows feet wrinkles & fine lines of grade 2-4 and dark spots & loose on face, neck and upper arms

• Registration Number: CTRI/2022/12/048271
• Lead Sponsor: Transformative Learning Solution Pvt Ltd

Brief Summary

PRIMARY OBJECTIVE

The objectiveof this study will be to evaluate efficacy of skin careformulation in terms of reduction in appearance of fine lines andwrinkles, density of dark spots, improvement in skin moisturization, skinfirmness on healthy female subjects.

SECONDARY OBJECTIVE

Secondary objective is toevaluate the in-vivo safety & efficacy of a skin care formulation in termsof Safety and improvement in skin water barrier & reduction incircumference of upper arm.

Product : BALAAYAHBLACK GRAM BRIGHT BODY BOOSTER (T6-0422) : Product A

The evaluation is performedusing : Subject’s Self Evaluation, Dermatological Evaluation:Safety, Dermatological Evaluation: Efficacy, Measurement of circumference ofupper arm, Tewametry( skin water barrier), Cutometry (R0 parameter for skin firmness),Corneometry (Capacitance parameter Skin Moisturization), Illustrative Images ofthe whole face & ¾ th face under diffuse light

Total duration of thestudy: 60 days following the first application of product.

Kinetics: T0, T+15 days,T+28 days, T+45 days and T+60 days

Product application :Once in a day application on whole face, neck and upper arms for the period of60 days

Number ofvolunteers: 36 female subjects

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-20
• Last Update Posted: 2023-09-29
• Study Completion: 2023-10-03

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 36

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

• 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 lamp …) in the previous year.
• 23 Having undergone surgery of the skin-muscular slackening on the face (lifting) in the previous 5 years.
• 24 Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…) 25 Having applied products with a depigmenting action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.
• 26 Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel …) in the previous 6 months.
• 27 Having a suntanned skin on the studied areas which could interfere with the evaluations of the study.
• 29 Having practiced sport, the day of start of the study.
• 30 Refusing to follow the restrictions below during the study: Do not start, change or stop a hormonal treatment (hormonal contraception, Hormone Replacement Therapy),Do not start a medicinal treatment which could lead to hyper pigmentation, Do not use products or techniques or surgery with an anti-wrinkles/ anti ageing action /firming action and depigmenting/ whitening action, Do not start an oral or local retinoid-based treatment, Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) or apply self-tanning products, Do not practice water activities (swimming pool, sauna, hammam, balneotherapy.), Do not practice sport the days of study, Do not expose herself to the sun by respecting a strict photo-protection.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in appearance of fine lines & wrinkles, Deansity of dark spots, improvement in skin moisturization,Skin firmness	Baseline, 15 Days, 28 Days,45 Days, 60 Days

Secondary Outcome Measures

Name	Time	Method
Skin safety, Improvement in skin water barrier, reduction in circumference of upper arm	Baseline, 15 Days, 28 Days,45 Days, 60 Days

Trial Locations

Locations (1)

Mascot Spincontrol India Pvt. Ltd.; 🇮🇳 Mumbai, MAHARASHTRA, India

Mascot Spincontrol India Pvt. Ltd.

🇮🇳Mumbai, MAHARASHTRA, India

Dr Raji Patil

Principal investigator

02243349191

raji@mascotspincontrol.in