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Repeat patch test on Humans with Normal Skin Type.

Evaluation of skin sensitization potential of investigational products by Human Repeat Insult Patch Test (HRIPT)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025777
Enrollment
100
Registered
2020-06-10
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

Sponsors

Dabur India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female subjects 18 to 65 years of age. 2. Subjects must be generally in good health as determined from a recent medical history which is on file with the investigator. 3. The ability of the subject to understand and sign a written informed consent form which must be obtained prior to treatment. 4. Willingness to avoid UV exposure (sun or artificial UV) on the test sites during the course of the study. 5. Subjects must have clear back. They should not have any infection or allergy on the tested area. They should have healthy skin on test area 6. Subjects should be cooperative, informed of the need and duration of the examination and ready to comply with the protocol procedures 7. Subjects having valid proof of identity and age. 8. Willingness to avoid excessive water contact (like swimming etc.) or activity which causes excessive sweating (like exercise, sauna, etc.) during the course of study 9. Subjects with skin photo type III to V

Exclusion criteria

Exclusion criteria: 1. Pregnant women/ Nursing mothers 2. Scars, excessive terminal hair, or tattoo on the studied area. 3. Dermatological infection/pathology 4. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material) 5. Any clinically significant systematic or cutaneous disease, which may interfere with study treatment or procedures 6. Chronic illness which may influence the outcome of the study. 7. Subject on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month) 8. Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial. 9. Subjects having mole or hair on the back which may influence the study results as per the investigator and study coordinator decision

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 with Normal skinTimepoint: Evaluation of Dermatological Safety of Investigational Products By 24 Hours Patch Test Under Complete Occlusion on Adult Healthy Human Subjects with Normal skin

Secondary

MeasureTime frame
NILTimepoint: NIL

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