None listed
Conditions
Interventions
Intervention1: Plastic ring (non-sterile): The plastic ring will be directly fixed in the patch set and will be applied on to the designated site for 48 or 72 hours.
Intervention2: Extractant of entir
Sponsors
Dermalogica, LLC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male & female participants in the age group 18 to 65 years (both ages inclusive). 2. Subjects in good health condition as per the health screening criteria with no disease state or physical condition that the Investigator believes could interfere with the interpretation of data. 3. Subjects who are able to understand and sign a written informed consent form. 4. Subjects willing to maintain the patch test in position for the required duration. 5. Subjects willing to come for regular follow-up visits. 6. Subjects with a broad upper back. 7. Subjects ready to follow instructions during the study period. 8. Subjects willing to avoid excessive water contact (like swimming etc.) or activity which causes excessive sweating (like exercise, sauna, etc.) during the course of study.
Exclusion criteria
Exclusion criteria: 1. Subjects with scars, infections, tattoos or wounds on the study area. 2. Subjects that have a known allergy to cosmetics, fragrances, skin care products, topical drugs, adhesive tapes and/or bandages/Band-aids®, or ingredients as related to the products being evaluated 3. Subjects with any clinically significant systemic or cutaneous disease (at the site of application), which may interfere with study treatment or procedures. 4. Subjects with chronic illness (such as bleeding or clotting disorders, hemophilia) which may influence the outcome of the study (self-declared). 5. Subjects who are immunosuppressed or immunodeficient due to medical condition or medication. 6. Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month) 7. Women who are pregnant, planning to become pregnant during the study, or breast-feeding. 8. Subjects who are on anticoagulant therapy (self-declared). 9. Subjects who are prone to actinic keratosis and keloid scars. 10. Subjects who have participated in a similar study within 1 month prior to the initiation of the study. 11. Subjects having moles or excessive hair on the back which may influence the study results as per the investigator and study coordinatorâ??s decision 12. Subjects affiliated with the Sponsor or lab conducting the study 13. Subjects with abnormal skin pigmentation at the test sites that could interfere with subsequent evaluations of dermal responsiveness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To determine the sensitization potential of test materials. 2. To determine the cumulative irritation potential of the test product by 10 occlusive applications.Timepoint: Induction phase : 10 multiple, 48 hours (72 hours on weekends) sets of patches at a single site on the upper back will be applied on Visits 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12. Rest phase for 21 days Challenge phase: Similarly, 2 sets of patches will be applied for 48 hours on Visits 13, 14, 15, 16. Visit 17- assessment 96 hours after patch removal. Rechallenge phase: in case of ambiguity on Visits 18, 19, 20, 21. | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactRadha S
MS Clinical Research Pvt. Ltd.
Outcome results
None listed