To study the irritant and allergic potential of test products in Men and Women.
- Registration Number
- CTRI/2024/07/070626
- Lead Sponsor
- Dr. Reddys Laboratories Ltd.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Voluntary men and/or women between 18 and 65 years with 50 participants having
sensitive skin as determined by lactic acid sting test @ .
2. Fitzpatrick skin type III to V.
3. Having apparently healthy skin on test area.
4. For whom the Investigator considers that the compliance will be correct.
5. Cooperating, informed of the need and duration of the examinations, and ready to comply
with protocol procedures.
6. Willing to give written informed consent to participate in the trial after informing all
information concerning the trial procedures and trial objectives.
7. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the
course of the trial.
8. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.:
exercise, sauna…), during the course of the trial.
9. Should be able to read and write (in English, Hindi, or local language).
10. Having valid proof of identity and age.
1. Pregnancy (by UPT) and lactating women.
2. Scars, excessive terminal hair, or tattoo on the studied area.
3. A participant who the Investigator feels will not be compliant with trial requirements
4. Dermatological infection/pathology on the level of studied area.
5. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye).
6. Any clinically significant systemic or cutaneous disease, which may interfere with trial
procedures.
7. Chronic illness which may influence the outcome of the trial.
8. Participants on any medical treatment either systemic or topical which may interfere with
the performance of the trial (presently or in the past 1 month).
9. Participant in an exclusion period or participating in another food, cosmetic or therapeutic
trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method