Safety and efficacy assessment of Product on skin

Completed

• Conditions: having 30 volunteers with oily skin, 10 volunteers with normal skin, 10 volunteers with sensitive skin (declaredthrough lactic acid sting test)

• Registration Number: CTRI/2023/03/050915
• Lead Sponsor: DPKA UNIVERSAL CONSUMER VENTURES PRIVATE LIMITED

Brief Summary

PRIMARY OBJECTIVE

To evaluate the in-vivo efficacy and safety of a skin careregime in terms of improvement in the Moisturisation, pH balance, radiance andskin smoothness, Reduction in sebum on healthy female subjects.

SECONDARY OBJECTIVE

To evaluate the efficacy and safety of a skin care regime interms of Improvement in skin brightness on healthy female subjects.

Test Product: Face Cleanser

ANCILLARY PRODUCT: STD MOISTURISER

The evaluation is performed using: 1) Subject SelfEvaluation 2)Dermatological Evaluation: safety 3) Dermatological Evaluation:Efficacy 4) Chromametry 5) Corneometry 6) Sebumetry 7) Skin PH metry 8) CLBT 9)IllustrativeImages of the whole face

Duration: 28 days following the first application of theproduct.

Kinetics: T0, T+30 minutes after Product application, T+1hour after Product application, T+4 hours after Product application, T+7 days,T+14 days, T+28 days

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-25
• Study Completion: 2023-05-30
• Last Update Posted: 2023-06-11

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 50

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)Between 18 and 50 years of age.
• 4)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 5)Having all skin type.30 oily skin ,10 normal skin , 10 subjects with sensitive skin (declared through lactic acid sting test).

Exclusion Criteria

• 1.Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2.Having refused to give her assent by signing the consent form 3.Taking part in another study liable to interfere with this study 4.Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area 5.Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 6.Having a progressive asthma (either under treatment or last fit in the last 2 years) 7.Being epileptic 8.Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 9Having cutaneous hypersensitivity 10.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex 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 undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 13.Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit 14.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). 15.Do not take part in any family planning activities leading to pregnancy and breastfeeding 16.Do not take part in another study liable to interfere with this study 17.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) 18.Do not change her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit 19.During the study: Do not use other cosmetic products than the tested products to the studied areas (only usual cleanser/soap is accepted) 20.The day of the measurements: No test product must be used (only face cleaned with water is accepted) 21.Having started, changed or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy) in the past 3 months. 22.Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months 23.Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months 24.Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta￾ carotene…) 25.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 26.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 27.Having applied products with a depigmenting action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study. 28.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 29.Having a suntanned skin on the studied areas which could interfere with the evaluations 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 take oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…).
• 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 action.
• 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 the	Baseline, 30 minutes, 1 hour, 4 hours, 7 days, 14 days, 28 days
Moisturization, pH balance, radiance and skin smoothness, Reduction in sebum	Baseline, 30 minutes, 1 hour, 4 hours, 7 days, 14 days, 28 days

Secondary Outcome Measures

Name	Time	Method
Improvement in skin brightness, product safety	Baseline, 30 minutes, 1 hour, 4 hours, 7 days, 14 days, 28 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