Repeat patch test on Humans with Normal Skin Type.
- Registration Number
- CTRI/2020/06/025777
- Lead Sponsor
- Dabur India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of Dermatological Safety of <br/ ><br>Investigational Products By 24 Hours Patch Test <br/ ><br>Under Complete Occlusion on Adult Healthy <br/ ><br>Human Subjects with Normal skinTimepoint: Evaluation of Dermatological Safety of <br/ ><br>Investigational Products By 24 Hours Patch Test <br/ ><br>Under Complete Occlusion on Adult Healthy <br/ ><br>Human Subjects with Normal skin
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI