Safety and efficacy assessment of Product on skin

Not yet recruiting

• Conditions: having Fitz Patrick Skin type III-IV and some female subjects having visible Melasma and dark spot (acne PIH) on face (with at least one dark spot 4mm in diameter).

• Registration Number: CTRI/2022/09/045309
• Lead Sponsor: SkinQ

Brief Summary

Objective:

PRIMARY OBJECTIVE

To assess the in-vivo efficacy and safety of a skin care regime in terms improvement in skin brightness & luminosity on healthy female subjects.

SECONDARY OBJECTIVE

To assess the in-vivo efficacy and safety of a skin regime in terms improvement in skin even tone, skin smoothness & reduction in melanin content of pigmentary spots (Acne PIH &/or melasma) on healthy female subjects.

Duration of study: 28 days study

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

Population: 36 (Females) volunteers

The evaluation is performed using:

1       Subject’s Self Evaluation,

2       Dermatological Evaluation: Cosmetic Acceptability,

3       Dermatological Evaluation: Efficacy

4       Chromametry

5       Mexametry

6       CLBT

7       Illustrative Images of the whole face under diffuse light

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-02-09
• Study Start: 2022-12-09

Recruitment & Eligibility

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

Inclusion Criteria

• 1Indian female subjects.
• 2Healthy 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) 3Between 18 and 45 years of age.
• 4Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 5Having Fitz Patrick Skin type III-IV.
• 6Some subjects having visible melasma and some subjects having dark spot (acne PIH) on face (with at least one dark spot >4mm in diameter).

Exclusion Criteria

• 1For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months Having refused to give his/her assent by not signing the consent form Taking part in another study liable to interfere with this study Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) Having acne prone skin. Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products. 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). Having cutaneous hypersensitivity. Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit. 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) 2Refusing 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 his/her cosmetic habits apart from the p.articular conditions mentioned in the protocol, on the studied anatomic unit. Do not practice water activities (swimming pool, sauna, hammam, balneotherapy) During the study: Do not use other cosmetic products than the tested products to the studied areas. Do not use hair oil. The day of the measurements : No other cosmetic products must be used (only face cleaned with water is accepted) 3Having started, changed or stopped a Hormone Replacement Therapy in the past 6 months. 4Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months. 5Having taken a Dehydroepiandrosterone based treatment in the previous 6 months. 6Having 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. 7Having made injections of anti-wrinkle products (collagen, hyaluronic acid, botulinic toxin…) in the previous 12 months. 8Having undergone techniques with aesthetic aim (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp …) in the previous year. 9Having undergone surgery of the skin-muscular slackening on the face (lifting) in the previous 5 years. 10Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta carotene…) 11Having applied products with a depigmenting action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study. 12Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel …) in the previous 6 months. 13Having consumed caffeine-based products (coffee, cola, tea …), alcohol, and highly spiced foods and/or smoked in the two hours preceding the measurements. 14Having a suntanned skin on the studied areas which could interfere with the evaluations of the study. 15Having had beauty treatment (e.g. scrub, self-tanning product …) on the studied areas in the previous week. 16Having practiced sport, the day of start of the study. 17Having a suntanned skin on the studied areas which could interfere with the evaluations of the study 18Refusing 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 DHEA-based treatment.
• Do not use products or techniques or surgery with an anti eye bags and / or anti dark circle and / or anti wrinkle action.
• Do not expose himself/herself to the sun with the intention to sunbathe (activities outside which do not last too much time are authorized).
• 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 consume caffeine-based products (coffee, cola, tea …), alcohol, highly spiced foods nor smoke in the two hours preceding the measurements each day of study.
• Do not practice sport the days of study.
• Do not expose yourself to the sun by respecting a strict photo-protection.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
improvement in skin	Baseline, Day14, Day28
brightness & luminosity	Baseline, Day14, Day28

Secondary Outcome Measures

Name	Time	Method
improvement in skin even tone, skin smoothness & reduction in melanin content of pigmentary spots (Acne PIH &/or melasma)	Baseline, Day14, Day28

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