Safety and efficacy assessment of Product on skin

Not yet recruiting

• Conditions: Volunteers with dull skin, pigmentary spots, crow’s feet wrinkles, uneven skin tone & visible under eye dark circle and presenting Fitzpatrick skin type III to V

• Registration Number: CTRI/2022/12/047808
• Lead Sponsor: Kama Ayurveda Pvt Ltd

Brief Summary

Objective:

PRIMARY OBJECTIVE To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of even skin tone, reduction in pigmentation (dark spot), radiant skin and skin brightness on healthy male & female subjects.

SECONDARY OBJECTIVE To evaluate the in-vivo efficacy of a skin care formulation in terms signs of ageing: minimize fine lines, smooth skin texture, reducing dark

Duration of study: 28 days study

Kinetics: T0, T+14 days and T+28 days

Population: 36 (18 Females & 18 Males) volunteers

The evaluation is performed using:

1. Subject’s Self Evaluation,

2. Dermatological Evaluation: Cosmetic Acceptability,

3. Dermatological Evaluation: Efficacy

4. Chromametry

5. Corneometry

6. CLBT (Color, Luminosity, Brightness, Transparency)

7. Cutometry

8. Tewametry

9. Sebumetry

10.  Mexametry

11.  Illustrative photographs of whole face & ¾ th face under diffused light

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-12

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• 1.Indian male and 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.Between 35 and 55 years of age.
• 4.Skin is healthy on the studied anatomic unit 5.Presenting Fitzpatrick skin type III to V, with chromameter (ITA value) reading between -30 & 41 on cheek bones.
• 6.Having dull skin and uneven skin tone 7.Having pigmentary spot on the face of grade 2 to grade 6 according to the Bazins atlas.
• 8.Having Crows feet wrinkle of grade 2 and above according to the Bazins atlas.
• 9.Having visible under eye dark circle.

Exclusion Criteria

• 1.For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2.Having refused to give his/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 acne prone skin.
• 6.Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 7.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
• 8.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).
• 9.Having cutaneous hypersensitivity.
• 10.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
• 11.Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
• 12.Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted) 13.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 change their cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit,-Do not have acne prone skin., During the study: Do not use other cosmetic products than the tested products to the studied areas., The day of the measurements: No test product must be used (only face cleaned with water is accepted) 14.Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months 15.Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months 16.Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements 17.Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months 18.Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…) 19.Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) or having applied self-tanning products in the week preceding the start of the study 20.Having applied products with anti-wrinkle action (Retinoic acid, retinol, retinaldehyde, isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study 21.Having applied products with a depigmenting/ whitening action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.
• 22.Having a suntanned skin on the studied areas which could interfere with the evaluations of the study 23.For males, having not shaved their beard 24 hours prior to the day of measurement.
• 24.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 take oral supplements with major or minor effheect on whitening of skin (e.g. vitamin C, beta-carotene…) -Do not consume caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements -Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) or apply self-tanning products -Do not use products or techniques or surgery with a depigmenting / whitening action -Do not expose herself to the sun by respecting a strict photo-protection.
• For males, having not shaved their beard 24 hours prior to the day of measurement.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Even skin tone,	Baseline, 14 days and 28 days
reduction in pigmentation (dark spot), radiant skin and skin brightness	Baseline, 14 days and 28 days

Secondary Outcome Measures

Name	Time	Method
ageing: minimize fine	lines, smooth skin texture, reducing dark circles and improvement in skin hydration

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