Repeat Insult Patch Testing (RIPT) APPENDIX I to HRL Standard Protocol #100
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation
Study Overview
Brief Summary
Patch Testing for device cream on human subjects
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or Female
- •18+ years
- •Good health
- •Signed and datad Informed Consent
- •Signed and dated HIPAA
Exclusion Criteria
- •On test at any other research lab or clinic
- •Known allergy or sensitivity to cosmetics or toiletries
- •Pre-existing other medical conditions
- •Treatment with antibiotics, antihistamines, or corticosteroids within 2 weeks of the test
- •Chronic medication which could affect the outcome of the study
- •Known pregnant or nursing women
- •Cancer diagnosis within the past 5 years
Arms & Interventions
Test Panel
Light Therapy Mask Cream
Intervention: Light Therapy Mask Cream (Device)
Outcomes
Primary Outcomes
Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation
Time Frame: approximately 6 weeks
"Clinically Significant Dermal Irritation" refers to an overall outcome measure in which, after 6 weeks of the test (patching the skin (3 weeks) \& then challenging the skin (at week 6)), the test product caused a clinically significant dermal reaction (scores of 2 or greater). Participant scores less than 2 are not considered to be Clinically significant. Scoring System: 0 = No visible reaction ± = Faint, minimal erythema 1. = Erythema 2. = Intense erythema 3. = Intense erythema, induration, vesicles 4. = Severe reaction with erythema, induration, vesicles, pustules (may be weeping) E = Edema DR = Dryness P = Peeling S = Staining * = Hyperpigmentation / Hypopigmentation C = Change of test site N9R = No 9th reading * = No patch application and / or reading TR = Tape Reaction
Secondary Outcomes
No secondary outcomes reported