Safety and Efficacy assessment of Product on skin

Not yet recruiting

• Conditions: having oily or mixed oily skin on the face

• Registration Number: CTRI/2022/10/046399
• Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief Summary

Objective:

The objective of this study is to evaluate the comedogenic effect of skin care formulation CebhydraMoisturizing Cream on healthy human female subjects

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

Population: 36 Females volunteers

The evaluation is performed using:

1     Dermatologist Evaluation: Counting of comedones

2     Sebumetry

3     Subject Self Evaluation (SSE) Questionnaire (Comedogenic Effect & Safety)

4     Subject Self Evaluation (SSE) Questionnaire (Cosmetic Appeal)

5     Dermatological Evaluation: Safety

Duration: 28 days following the first application of the product.

**Study Duration**(Screening period to Last-Patient-Out) (A+B+D)**:**40 days

**Study Duration**(First Patient-In to Last-Patient-Out) (B+D)**:**28 days

***A = Screening period****(Period for identification of eligible 36 subjects): 12 days*

***B = Enrollment period****(Period for conducting baseline visits of 36 subjects): 0 day*

***C = Run-in period:****Not applicable*

***D = Treatment period per patient:****28 days*

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-16

Recruitment & Eligibility

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

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 35 years of age.
• 4 Skin is healthy on the studied anatomic unit (e.g. free of eczema, wounds, inflammatory scar) 5 Having oily or mixed oily skin type on the face (Visual assessment by dermatologist).

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 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 a progressive asthma (either under treatment or last fit in the last 2 years) 6 Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 7 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8 Being epileptic.
• 9 Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 10 Having cutaneous hypersensitivity.
• 11 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
• 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 except those required by the protocol 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 Having applied hair oil during the entire duration of the study.
• 16 In the previous 6 months -Having started, changed or stopped a hormonal treatment (e.g. hormonal contraception, cyproterone acetate) -Having taken an oral retinoid-based treatment -Having undergone a physical (e.g., phototherapy, laser) or chemical (peeling) treatment for acne 17 In the previous 1 month -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 (zinc gluconate) or spironolactone 18 In the previous 2 weeks -Having applied cosmetic products with anti-seborrheic aims or cosmetics for oily skin -Having had oral or local antibiotic treatment for acne 19 In the previous 1 week -Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask) -Having a suntanned skin on the studied areas which could interfere with the evaluations of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent reduction in total number of comedones	14days, 28days

Secondary Outcome Measures

Name	Time	Method
Percent reduction in sebum, safety of Product	14days, 28days

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