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

To evaluate the in vivo safety and efficacy of a skin care formulation in terms of Skin Brightening, skin even tone, skin smoothness, softness and reduction in intensity of acne PIH on healthy human subjects - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093104
Enrollment
36
Registered
2025-08-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

None listed

Interventions

Intervention1: Serum: The product is applied on the whole face two times in a day for the period of 28 days Control Intervention1: Nil: NA

Sponsors

Multani Pharmaceuticals Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Indian or Asian female subjects 2.Healthy subjects 3.Skin is healthy on the studied anatomic unit 4.Having wheatish to dark complexion. 5.Having acne PIH at least one spot of 3mm or more

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
Skin Brightening, skin even tone, skin smoothness, softness and reduction in intensity of acne PIHTimepoint: Baseline, 30 minutes, 7 days,14 days, 28 days—

Secondary

MeasureTime frame
NilTimepoint: NA—

Countries

India

Contacts

Public ContactDr. Ruchi Srivastava

MASCOT-SPINCONTROL India Pvt. Ltd.

poojayadav@mascotspincontrol.in02243349191

Outcome results

None listed

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