None listed
Conditions
Interventions
Intervention1: Bodywise 1% Ketoconazole Shampoo: Filter papers dipped in 8% w/w solution of the shampoo prepared in distilled water (to contain approximately 0.04 ml of solutions) will be filled in di
Sponsors
Mosaic Wellness Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Voluntary men and women (preferably equal number of males and females) between 18 and 65 years. 2. Fitzpatrick skin type III to IV. 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 (swimming) or activity which cause sweating (exercise, sauna�), during the course of the trial. 9. Should be able to read and write (in English, Hindi, or local language).
Exclusion criteria
Exclusion criteria: 1.Pregnancy (by history) 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 of skin reactions (erythema, oedema, dryness, scaling wrinkling), using Draize scale.Timepoint: 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactMr Abhinav Gupta
Mosaic Wellness Private Limited
Outcome results
None listed