Safety & Efficacy assessment of skin care regime

Not yet recruiting

• Conditions: Having all skin type(oily skin, normal skin, sensitive skin (declared through lactic acid sting test)).

• Registration Number: CTRI/2023/06/054039
• Lead Sponsor: DPKA UNIVERSAL CONSUMER VENTURES PRIVATE LIMITED

Brief Summary

OBJECTIVE

PRIMARY OBJECTIVE: The objective of this studywill be to evaluate the in-vivo efficacy and safetyof a skin care regime in terms of improvement in the Moisturisation, and skinsmoothness on healthy female subjects having varied skin type.

SECONDARYOBJECTIVE : Theobjective of this study will be toevaluate the efficacy and safety of a skin care Regime in terms of Improvementin Skin Brightness, Sebum reduction on healthy female subjects having variedskin type.

coded:

Gel Moisturizer: Product A

STD FACEWASH: Product B

 The evaluation is performed using:

-SubjectSelf Evaluation

-DermatologicalEvaluation: safety

-DermatologicalEvaluation: Efficacy

-Chromametry

-Corneometry

-Sebumetry

-IllustrativeImages of the whole face

The study lasts 28 days following the first applicationof the product on the whole face.

 POPULATION

56 female subjects *are selected for the study.*

The subjects selected for this study are healthy femalesubjects, aged between 21 to 50 years, having32 subjects with oily skin + 12 subjects with normal skin + 12 subjects withsensitive skin (declared through lactic acid sting test)].

Kinetics

T0, T+30 minutes after product application, T+4 Hours,T+6 Hours  T+7 days, T+14 days & T+28 days

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-06-13
• Study Start: 2023-06-22

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

• Indian / Asian 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 21 and 50 years of age 4.
• Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 5.Specific criteria 5.1 Having all skin type.
• 5.2 32 oily skin +12 normal skin + 12 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 his/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) 9.Having 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.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 his/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 than the tested products to the studied areas (Standard facewash provided by sponsor should only be used) -The day of the measurements: No test product must be used (only face cleaned with water is accepted). 16. Specific criteria – -Having started, changed, or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy) in the past 3 months. -Having started, changed, or stopped his/her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months -Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months -Taking oral supplements with major or minor effect on whitening of skin (e.g., vitamin C, beta carotene…) -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 -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 -Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements -Having applied products with a depigmenting action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study. -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 -Having a suntanned skin on the studied areas which could interfere with the evaluations of the study 17. 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 consume caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements.
• 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 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
Efficacy & safety of a skin care regime in terms of improvement in the	Baseline, 30 minutes,4 Hours,6 Hours,7 days,14 days & 28 days
Moisturisation, & skin smoothness	Baseline, 30 minutes,4 Hours,6 Hours,7 days,14 days & 28 days

Secondary Outcome Measures

Name	Time	Method
Efficacy & safety of a skin care Regime in terms of improvement in Skin	Brightness & Sebum reduction

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