None listed
Conditions
Interventions
Intervention1: Photostable new formulation-
OCTCB: Approximately 0.04 g of test product will be filled in well of patch chamber and applied
occlusively on back of participant. Patches will be secured
Sponsors
Sun Pharmaceutical Industries Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Voluntary healthy men and women between 18 and 65 years. 2. Photo 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. Having signed a Consent Form. 7.Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study. 8. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, sauna etc), during the course of the study. 9. Should be able to read and write (in English, Hindi or local language). 10. Having valid proof of identity and age.
Exclusion criteria
Exclusion criteria: 1. Pregnancy (by UPT) and lactating women. 2. Scars, excessive terminal hair or tattoo on the studied area. 3. Dermatological infection/pathology on the level of studied area. 4. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye). 5. Any clinically significant systemic or cutaneous disease, which may interfere with study procedures. 6. Chronic illness which may influence the outcome of the study. 7. Participants on any medical treatment either systemic or topical which may interfere with the performance of the study (presently or in the past 1 month). 8. Participant in an exclusion period or participating in another food, cosmetic or therapeutic trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of cutaneous tolerance by dermatological scoring (Draize scale for Induction scoring and ICDRG scale for Challenge scoring).Timepoint: Induction Phase: - Patch application on Visit V1, V3, V5, V7, V9, V11, V13, V15 and V17. - Patch removal on Visit 2 (V2, V4, V6, V8, V10, V12, V14, V16 and V18). - Scoring on Visit 3 (V3, V5, V7, V9, V11, V13, V15, V17, V19) Rest Phase: 10 â?? 14 days Challenge Phase: Patch application will be on naïve sites on the arm/back on V20; patch will be removed at V21 (24 hours). Scoring on V22 (48 hours), V23 (72 hours). V24 (96 hours). | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Amit Thavkar
Sun Pharmaceutical Industries Ltd.
Outcome results
None listed