Safety and Efficacy assessment of Product on ski

Not Applicable

• Registration Number: CTRI/2022/05/042840
• Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 35 years of age.

4Skin is healthy on the studied anatomic unit (e.g. free of eczema, wounds, inflammatory scar)

5Having oily or mixed oily skin type on the face (Visual assessment by dermatologist)

Exclusion Criteria

1Being pregnant or breastfeeding or having stopped to breastfeed in the past three months

2Having refused to give her assent by not 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)

5Having a progressive asthma (either under treatment or last fit in the last 2 years)

6Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)

7Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)

8Being epileptic.

9Following 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)

10Having cutaneous hypersensitivity.

11Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.

12Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.

13Having 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.

14Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted)

15Having applied hair oil during the entire duration of the study.

16In 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

17In 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

18In 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

19In 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 stud

Study & Design

• Study Type: Interventional
• Study Design: Not specified