None listed
Conditions
Interventions
Intervention1: Positive Control: 1. SKINOVATE Non-Hydroquinone night cream- repeated occlusive Patches to
be applied on back of subject
skin during induction phase &
challenge phase.
2. SKINOVATE HA F
Sponsors
Skinovate Laser & Cosmetic Surgery center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male and female volunteers aged 18 to 65 with no active dermatological conditions 2. Good general and mental health with, in the opinion of the investigator or medically qualified designee with no clinically significant and relevant abnormalities in medical history or upon physical examination 3. Subjects who have intact skin on the proposed application site; dorsum (scapular region) 4. Fitzpatrick photo type I to IV skin type 5. Willingness to participate as evidenced by voluntary written informed consent
Exclusion criteria
Exclusion criteria: 1. Women who are known to be pregnant or who are intending to become pregnant over the duration of the study 2. Women who are breast-feeding 3. Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) 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 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. 7. History of diseases aggravated or triggered by 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 vitamin A 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 allergy injections, or due to receive an injection within 7 days prior to Visit1, or expects to begin injections during study participation 14. Previous history of atop, allergic reactions, irritation or intense discomfort feelings to topical use products, cosmetics, or medication 15. Known or suspected intolerance or hypersensitivity to any of the study materials (or closely related compounds) or any of their stated ingredient including any component of the patches 16. History of sensitization in a previous patch study 17. Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30days of the screening visit 18. Recent history (within the last years) of alcohol or other substance abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To ascertain the irritation potential of 3 investigational products after removal of occlusive patch after every 24 (±2) hours in sequential manner for 37 days which includes 18 days of Induction phase, 14 days Resting phase & 5 days of Challenge phase to the skin of healthy volunteers.Timepoint: D1 to D18, 18 days of Induction phase D19 to D32, 14 days of resting phase D33 to D36, 5 days of Challenge Phase | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the general safety of 3 investigational products. Timepoint: Assessed during, D1 to D18, 18 days of Induction phase D19 to D32, 14 days of resting phase D33 to D36, 5 days of Challenge Phase | — |
Countries
India
Contacts
Public ContactDr Sunil Chaudhary
Lifepoint Multispecialty Hospital
Outcome results
None listed