None listed
Conditions
Interventions
Intervention1: DRDC/2023/032: Filter papers dipped in diluted ‘DRDC/2023/032’ (to contain approximately
0.04 ml of solution), will be filled in well of patch chambers and will be applied occlusively o
Sponsors
Dabur Research and Development Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Voluntary men and 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. Willingness to discontinue the use of cleansing and/or cosmetic products in the application areas during the course of the trial. 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. Ready to wear loose cotton clothes. 11. Having valid proof of identity and age. 12. Subject having not participated in another similar cosmetic or therapeutic trial in the past one month.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of cutaneous tolerance by dermatological scoring.Timepoint: Visit 1: ICD and inclusion/ exclusion. Induction Phase: Patch application on Visit 1 (V1, V3,V5, V7, V9, V11, V13, V15, V17). Patch will be removed on Visit 2 (V2, V4, V6, V8, V10, V12,V14, V16, V18). Patch area will be clinically examined, graded and scored on Visit 3 (V3, V5, V7, V9, V11, V13, V15, V17, V19) Challenge Phase: Patch application will be on naïve sites on the 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 |
|---|---|
| NoneTimepoint: None | — |
Countries
India
Contacts
Public ContactDr Sasi Bhushan Vedula
C.L.A.I.M.S. Pvt. Ltd.
Outcome results
None listed