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

To evaluate the in vivo safety and efficacy of skin care formulation in terms of improvement in skin brightness on healthy human subjects - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/081363
Enrollment
36
Registered
2025-02-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

None listed

Interventions

Intervention1: Soulflower Sandalwood Soap: The Product is applied on whole face two times in a day for the period of 28 days. Control Intervention1: Nil: NA

Sponsors

PT Invent India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Indian male and female subjects. 2)Healthy subjects 3)Skin is healthy on the studied anatomic unit 4)Having wheatish to dark complexion.

Exclusion criteria

Exclusion criteria: 1. Being pregnant or breastfeeding or having stopped to breastfeed in the past three months. 2. 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. 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 or corticosteroid by any route (the only medication permitted is paracetamol) 10. Known case of 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 anaesthetic of more than one hour in the past 6 months.

Design outcomes

Primary

MeasureTime frame
Improvement in skin brightnessTimepoint: Baseline, Day 7, Day 14 and Day28

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