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Study to assess safety and effectiveness products on human volunteers

To evaluate the in vivo safety and efficacy of the skin care formulation in terms of reduction in acne on healthy female subjects - Nil

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083220
Enrollment
30
Registered
2025-03-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Anti Acne Gel: The Product is applied on whole face once in a day for the period of 28 days Control Intervention1: Nil: NA

Sponsors

AU Naturel Beauty Pvt. Ltd (NEUDE).
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Indian subjects 2)Healthy subjects 3)Skin is healthy on the studied anatomic unit 4) Having mild to moderate acne. 5)Having mixed oily or oily skin on the face

Exclusion criteria

Exclusion criteria: 1. Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2. Having refused to give her/his 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, anti-histamines, 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 anesthetic of more than one hour in the past 6 months.

Design outcomes

Primary

MeasureTime frame
Reduction in acneTimepoint: Baseline, Day 7, Day 14 and Day 28

Secondary

MeasureTime frame
NilTimepoint: NA

Countries

India

Contacts

Public ContactDr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

poojayadav@mascotspincontrol.in02243349191

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026