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

NCT ID: NCT03450070

Last Updated: 2019-05-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-15

Study Completion Date

2017-12-22

Brief Summary

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Patch Testing for device cream on human subjects

Detailed Description

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Conditions

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Allergic Sensitization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Test Panel

Light Therapy Mask Cream

Group Type EXPERIMENTAL

Light Therapy Mask Cream

Intervention Type DEVICE

test panel

Interventions

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Light Therapy Mask Cream

test panel

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Harrison Research Laboratories

Union, New Jersey, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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CO- 171028001439-SACT

Identifier Type: -

Identifier Source: org_study_id

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