Repeat Insult Patch Test APPENDIX I to HRL Standard Protocol #100

Not Applicable

Completed

• Conditions: Allergic Sensitization
• Interventions: Device: Light Therapy Mask Cream

• Registration Number: NCT03450070
• Lead Sponsor: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

Brief Summary

Patch Testing for device cream on human subjects

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-15
• Primary Completion: 2017-12-22
• Study Completion: 2017-12-22
• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-03-01
• Results First Submitted: 2018-12-20
• Results First Submitted QC: 2019-03-13
• Results First Posted: 2019-04-03
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test Panel	Light Therapy Mask Cream	Light Therapy Mask Cream

Primary Outcome Measures

Name	Time	Method
Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation	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

Trial Locations

Locations (1)

Harrison Research Laboratories; 🇺🇸 Union, New Jersey, United States