Safety and efficacy assessment of Product on ski
- Conditions
- Health Condition 1: L700- Acne vulgaris
- Registration Number
- CTRI/2022/09/045184
- Lead Sponsor
- SkinQ
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
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)
3Between 18 and 30 years of age.
4Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ?¦.)
5Having mild to moderate acne and oily to mixed oily skin type & visible pores.
1For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2Having refused to give his/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 acne prone skin.
6Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
7Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
8Following 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).
9Having cutaneous hypersensitivity.
10Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
11Having changed 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: 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 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). For Males: Shaving should be done before one day of T0 visit and 3 hrs before the night application on T+2 days
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 -Having allergy to asprin / sulpha (salicylic acid).
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 (hormona
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method reduction in acne, <br/ ><br>reduction in sebum, reduction in pore size and improvement in skin brighteningTimepoint: baseline, 15 minute, 1 day, 3 days
- Secondary Outcome Measures
Name Time Method improvement in skin even toneTimepoint: baseline, 15 minute, 1 day, 3 days