None listed
Conditions
Interventions
Intervention1: Demelan Facewash: NOT APPLICABLE
Control Intervention1: Not applicable: Not applicable
Sponsors
Sami-Sabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Must provide a voluntarily signed written informed consent form and must be willing to follow the guidelines as mentioned in the protocol. 2. Healthy male and female volunteers aged 18 to 65 with no active dermatological conditions 3. Subjects should be in good general and mental health condition as per the assessment and opinion of the investigator or a medically qualified designee with no clinically significant abnormalities in medical history or upon physical examination 4. Subjects must have an intact skin on the proposed application site; (dorsum scapular region and the upper forearm region) 5. Skin type that belongs to Fitzpatrick photo type I to VI.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Women who are known to be pregnant or who intend to become pregnant during the study period. 2. Women who are breast-feeding 3. Any history of significant dermatological diseases or medical conditions known to alter skin appearance which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction. 4. Presence of any open sores, pimples, or cysts at the application site. 5. Active dermatosis (local or disseminated) that might interfere with the results of the study. 6. Considered immune compromised by the PI. 7. Medical history of any allergies or reactions triggered by exposure to sunlight or ultraviolet radiation. 8. Participants with dermatographism. 9. Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk. 10. Use of the following topical or systemic medications: immunosuppressants, antihistamines, nonhormonal anti-inflammatory drugs, and corticosteroids up to 2 weeks before screening visit. 11. Oral or topical treatment with retinoic acid and/or its derivatives up to 1 month before the screening visit 12. Intention of being vaccinated during the study period or vaccination within 3 weeks of the screening visit. 13. Currently receiving injections or medications to treat allergies. 14. Previous history of atopic dermatitis, allergic reactions, irritation or intense discomfort feelings on usage of topical products, cosmetics, or medications. 15. Known or suspected intolerance or hypersensitivity to any of the ingredients present in the investigational product. 16. History of sensitization in any of the patch tests conducted earlier. 17. Participation in another clinical study (including cosmetic studies) or receipt of an investigational product within 30days of the screening visit 18. Recent history (within the last 6 months) of alcohol or other substance abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary analysis for skin irritation will be based on the Draize scale score assigned by the primary investigator/dermatologist/designee. Timepoint: Day 2 & Day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability will be evaluated based on the incidence, frequency & the casual relationship between the AE/SAE and the investigational product. The AE/SAE data will be summarized by presenting the number and percentage of subjects having any AE/SAE. Timepoint: Day 2 & Day 3 | — |
Countries
India
Contacts
Public ContactDr Sushil Chaudhary
Skinovate Laser & Cosmetic Surgery Centre
Outcome results
None listed