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Repeat patch test on Humans with Normal Skin Type.

Not Applicable
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
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

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
NameTimeMethod
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
NameTimeMethod
ILTimepoint: NI
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