None listed
Conditions
Interventions
Intervention1: Finn chamber: Each patch contains 40 micrograms/microliter of 1.MBG-179 2. MBG-180 3. Negative control0.9% NaCl, 4. Positive Control- 1% SLS Route of Administration: Topical Frequency:
Sponsors
Jolune
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female, between 18 and 65 years of age, inclusive. 2. In good general health as determined by medical history and physical examination. 3. Willing and able to provide written informed consent prior to any study-related procedures. 4. Willing and able to comply with all study procedures and visit schedules. 5. Skin on the upper back must be free of acne, sunburn, scars, tattoos, moles, or any other condition that could interfere with patch application or skin evaluation. 6. Females of childbearing potential (FOCP) must have a negative urine pregnancy test at screening and agree to use a medically acceptable method of contraception throughout the study.
Exclusion criteria
Exclusion criteria: 1. History of or active dermatological condition (e.g., eczema, psoriasis, dermatitis) on the back or that could be exacerbated by the study. 2. Known allergy or sensitivity to cosmetics, topical drugs, medical adhesives (tapes), or any of the test material components, including SLS. 3. Use of systemic or topical corticosteroids, retinoids, or immunosuppressants within 4 weeks prior to Day 0. 4. Application of any topical product (including moisturizers) to the back within 24 hours prior to Day 0. 5. Excessive sun exposure or use of tanning beds on the back within 2 weeks prior to Day 0. 6. Currently pregnant, planning to become pregnant, or breastfeeding. 7. Participation in any other clinical trial involving an investigational drug or device within 30 days prior to Day 0. 8. Any condition which, in the opinion of the Principal Investigator, would place the subject at undue risk or interfere with the interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Skin Irritation Score-erythema & oedemaTimepoint: Day1, Day3, Day5, Day8, Day10 and Day12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactPuneet Mittal
CCFT Laboratories
Outcome results
None listed