The Study to assess safety and effectiveness of product on human volunteers

Not yet recruiting

Conditions: having normal skin type with visible Acne PIH(L81.0 - Post-inflammatory hyperpigmentation)

Registration Number: CTRI/2025/04/085889

Lead Sponsor: Satiya Nutraceuticals Private Limited

Brief Summary: OBJECTIVE - To evaluate the in-vivo efficacy andsafety of a skin care regime in terms of reduction in hyperpigmentation (AcnePIH), improvement in Skin brightness, skin tone evenness and skin texture onhealthy female subjects for product coded:

The evaluation will be performed using, SubjectSelf Evaluation, Dermatological Evaluation: Cosmetic Acceptability, DermatologicalEvaluation: Efficacy, Mexametry, Chromametry, Corneometry

POPULATION-72 (36 for test regime and 36 forplacebo regime) Female subjects will be selected for the study.

The subjects selected for this study are healthyfemales, aged between 18 and 40 years old, having normal skin type with visibleAcne PIH (at least one spot of 3mm or more) and dull skin.

STUDY DURATION- 28 days following the firstapplication of the test product.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 72

Inclusion Criteria

1)Indian Female subjects 2)Healthy subjects 3)Skin is healthy on the studied anatomic unit 4)Having normal skin type 5)Having visible Acne PIH 6)Having dull skin.

Exclusion Criteria

Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
Having refused to give his/her assent by not signing the consent form and Informed consent form 3.
Taking part in another study liable to interfere with this study 4.
Being known diabetic case 5.
Known asthma case 6.
Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 7.
Being known thyroid case 8.
Being epileptic.
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 or corticosteroid by any route (the only medication permitted is paracetamol) 10.
Known case of hypersensitivity.
Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in hyperpigmentation (Acne PIH), improvement in Skin brightness, skin tone evenness and skin texture	Baseline, Day 14 and Day 28

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Mascot Spincontrol India Pvt. Ltd.
🇮🇳
Mumbai, MAHARASHTRA, India
Mascot Spincontrol India Pvt. Ltd.
🇮🇳Mumbai, MAHARASHTRA, India
Dr Pooja Yadav
Principal investigator
02243349191
poojayadav@mascotspincontrol.in