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

N/ACompletedNCT03450070

Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.121 enrolled

Overview

Patch Testing for device cream on human subjects

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

121

Conditions

Allergic Sensitization

Interventions

Light Therapy Mask CreamDEVICE

test panel

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Harrison Research Laboratories

Union, New Jersey, United States

Outcomes

Primary Outcomes

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 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

Time frame: approximately 6 weeks

Data from ClinicalTrials.gov

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