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

Repeat Insult Patch Testing (RIPT) APPENDIX I to HRL Standard Protocol #100

Patch Testing for device cream on human subjects

Study Overview

• Status: Completed
• Conditions: Allergic Sensitization
• Intervention / Treatment: Device: Light Therapy Mask Cream

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Union, New Jersey, United States, 07083
      • Harrison Research Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Panel; Light Therapy Mask Cream	Device: Light Therapy Mask Cream; test panel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation	"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; = Erythema; = Intense erythema; = Intense erythema, induration, vesicles; = 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	approximately 6 weeks

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Actual): December 22, 2017
• Study Completion (Actual): December 22, 2017

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CO- 171028001439-SACT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No