Evaluation of Safety and Efficacy of Product

Not yet recruiting

Conditions: Having oily & mixed oily skin (having acne prone skin) and combination skin type with acne lesions, blackhead, whiteheads & visible pores.

Registration Number: CTRI/2022/05/042724

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 reduction in acne & acne PIH, improvement in skin texture (i.e., softness & smoothness), reduction in pore size, reduction in sebum content, improvement in skin brightenesss on healthy male & female subjects.

SECONDARY OBJECTIVE To evaluate the in-vivo efficacy of a skin care formulation in terms of balancing skin pH and improvement in skin plumpness on healthy male & female subjects.

Duration of study: 28 days study

Kinetics: T0, T+15 minutes after product application and T+28 days

Population: 36 (18 Females & 18 Males) volunteers

The evaluation isperformed using:

1      Subject Self Evaluation

2      Dermatological Evaluation: CosmeticAcceptability

3      Dermatological Evaluation: Efficacy

4      Sebumetry â–ª Chromametry

5      Skin pH metry

6      Illustrative Images of the whole &3/4th face under diffuse light

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 36

Inclusion Criteria

1Indian male and 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) 3Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) Specific criteria 4Having oily & mixed oily skin (having acne prone skin) and combination skin type with acne lesions, blackhead, whiteheads & visible pores.

Exclusion Criteria

1For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2Having refused to give her/his assent by signing the consent form 3Taking part in another study liable to interfere with this study 4Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 5Being asthmatic.
6Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex 7Following 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).
8Having cutaneous hypersensitivity.
9Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
10Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
11Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
12Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted) 13Refusing to follow the restrictions below during the study: For Females: 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, Do not use hair oil ,The day of the measurements : No other cosmetic products must be used (only face cleaned with water is accepted) 14In the 6 previous months ,Having started, changed or stopped a hormonal treatment (hormonal contraception, cyproterone acetate â€¦), Having taken an oral retinoid-based treatment 15In the previous month, Having undergone a physical (phototherapy, laser ..) or chemical (peeling) treatment for acne, Having had a local benzoyl-peroxide-based treatment or a local retinoid-based treatment,Having had an oral treatment with a base of cimetidine, zinc (gluconate of zinc) or spironolactone 16In the 2 previous weeks, Having applied cosmetic products with anti-seborrheic aims or cosmetics for oily skin, Having had oral or local antibiotic treatment for acne, Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask â€¦), Having a suntanned skin on the studied areas which could interfere with the evaluations of the study 17Refusing to follow the restrictions below during the study: Do not apply cosmetic products with anti-seborrheic aims or cosmetics for oily skin, Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask â€¦), Do not start, change or stop a hormonal treatment (hormonal contraception, cyproterone acetate â€¦), Do not start a local or general treatment acting on seborrhoea , Do not expose himself/herself to the sun, Strictly avoid sun exposure.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
acne PIH, improvement in skin texture (i.e., softness & smoothness), reduction in pore size, reduction	15 minutes, 28 days
Reduction in acne &	15 minutes, 28 days
in sebum content, improvement in skin brightenesss	15 minutes, 28 days

Secondary Outcome Measures

Name	Time	Method
Balancing skin pH and	improvement in skin plumpness

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