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Skin Safety study on Healthy Human Subjects of all types Skin

To Evaluate Dermatological Safety of Investigational Products In Single Open Application Test on Adult Healthy Human Subjects of All Skin Types

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/05/019100
Enrollment
48
Registered
2019-05-14
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.Fem Fairness Naturals Herbal Creme Bleach 2.Fem Fairness Naturals Fruit Creme Bleach 3.Fem Fairness Ayurvedic Care Creme Bleach 4.Fem Fairness Naturals De tan creme bleach 5.Fem Fairn

Sponsors

Dabur India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy female subjects in the age group of 18-65 years (both age inclusive). 2.Subjects with normal, dry, oily, combination and sensitive skin (preferably in equal ratio). 3.Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumannâ??s skin type questionnaire to qualify as sensitive skin. 4.Subjects with normal Fitzpatrick skin type III to V. 5.Subjects free from excessive hair, cuts, wounds, irritation symptoms, abrasion or any other skin condition which may interfere in the study results. 6.Subjects willing to give a voluntary written informed consent. 7.Subjects willing to maintain the patch test in position for 24 hours. 8.Subject having not participated in a similar investigation in the past two weeks. 9.Subjects willing to come for regular follow up visits. • Subjects ready to follow instructions during the study period

Exclusion criteria

Exclusion criteria: 1.Infection, allergy on the tested area. 2.Skin allergy antecedents or atopic subjects. 3.Subjects with known hypersensitivity to any of the study products or constituents. 4.Subjects with any significant skin pathology in the investigational area 5.Athletes and subjects with history of excessive sweating. 6.Cutaneous disease which may influence the study result. 7.Subjects using any topical or systemic treatment that could interfere with the study treatments/assessments within the last 4 weeks prior to participation in the study and during the study. 8.Subjects on oral corticosteroid. 9.Subjects participating in any other cosmetic or therapeutic study. 10.Female subjects who are pregnant or lactating. 11.Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness

Design outcomes

Primary

MeasureTime frame
Evaluation of Dermatological Safety of Investigational Products By 24 Hours Patch Test Under Complete Occlusion on Adult Healthy Human Subjects of all Skin typeTimepoint: 0 hr, 24 hr, 48 hr & 7 days

Secondary

MeasureTime frame
Overall Safety of the SubjectsTimepoint: 0 hr, 24 hr, 48 hr & 7 days

Countries

India

Contacts

Public ContactRitambhara

Dabur India Limited

arun.gupta@dabur.com01203378614

Outcome results

None listed

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