MedPath

Safety and efficacy assessment of Product on ski

Not Applicable
Registration Number
CTRI/2024/03/063536
Lead Sponsor
DPKA Universal Consumer Ventures Private. Limited.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1) Indian / Asian female subjects

2) Healthy subjects

3) Having dull skin & having wheatish to dark skin.

4) 15 normal skin volunteers,35 dry skin volunteers

5) 10 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 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Improvement in skin brightening, skin hydration, skin smoothness, skin pH balance and skin water barrier functionTimepoint: Baseline, 30 minutes, 2 hour, 4 hour, 7 days, 14 days
Secondary Outcome Measures
NameTimeMethod
ilTimepoint: NA
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