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Dermatological Safety Study on Healthy Human Subjects

Evaluation of dermatological safety of investigational products (Skin care formulations) by 24hrs patch test under complete occlusion on healthy human subjects.

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/08/007194
Enrollment
26
Registered
2016-08-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: 1.Nuface Ultra Sunscreen Gel 2. Femglo Skin Brightener Cream 3. Botanica Antiageing Gel 4.Botanica 3D Serum 5. Aloederm Aloe Hydro Gel 6. Uproot lotion.: Products were evaluated through

Sponsors

Dabur India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Both Female and male subjects in age group between 18 and 50 years (both the ages inclusive). 2.Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup) 3.Skin is healthy on the studied anatomic unit i.e. back of subject (free of eczema, wounds, inflammatory scarâ?¦.)

Exclusion criteria

Exclusion criteria: 1.For female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2.Subject not willing to give voluntary Consent. 3.Taking part in another study liable to interfere with this study 4.Any history of underlying uncontrolled medical illness including diabetes, Asthma, Liver disease or any other serious medical illness. 5.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). 6.Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin). 7.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 8.Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit. 9.Having eczema, psoriasis, lichen plan, vitiligo whatever the considered area 10.Having disorder of the healing (whatever the considered area) 11.Having a rhinitis, allergic conjunctivitis or rhino sinusitis 12.Having an allergy to perfumes and/or conservatives in cosmetic products 13.Having an allergy to plaster 14.Having a food allergy 15.Having a cardiovascular pathology (taking a beta blocker treatment) 16.Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc. 17.Taking a retinoid based treatment by general or oral route 18.Taking specific treatment on the back 19.Having miliaria (prickly heat) on the back. 20.Presenting too many naevus on the back 21.Having high pilosity on the back

Design outcomes

Primary

MeasureTime frame
Evaluation of dermatological safety of investigational products by 24 hours patch test under complete occlusion on healthy human subjects.Timepoint: 0 hr, 24 hr, 8 days (Post 1 week after 0 hours of patch removal)

Secondary

MeasureTime frame
Overall safety of SubjectsTimepoint: 0 hr, 24 hr, 8 days (Post 1 week after 0 hours of patch removal)

Countries

India

Contacts

Public ContactDr Arun Gupta

Dabur India Limited

arun.gupta@dabur.com01203378614

Outcome results

None listed

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