Patch Test Skin Irritation/Sensitization of Cetaphil Restoraderm Skin Restoring Body Wash

NCT ID: NCT01892410

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Brief Summary

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Determine if Cetaphil Restoraderm Skin Restoring Body Wash proves to be a contact sensitizer or irritant in certain individuals.

Detailed Description

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Conditions

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Skin Irritation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cetaphil Restoraderm Skin Restoring Body Wash

All subjects receive Cetaphil Daily Advance Ultra Hydrating Lotion

Group Type EXPERIMENTAL

Cetaphil Restoraderm Skin Restoring Body Wash

Intervention Type OTHER

Diluted (10%) 0.2ml or 0.2g of Cetaphil on semi-occlusive, hypoallergenic patch applied to skin for 24 hrs 9 times on Monday, Wednesday, and Friday for 3 weeks

Interventions

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Cetaphil Restoraderm Skin Restoring Body Wash

Diluted (10%) 0.2ml or 0.2g of Cetaphil on semi-occlusive, hypoallergenic patch applied to skin for 24 hrs 9 times on Monday, Wednesday, and Friday for 3 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Not currently under a doctor's care
* Free of dermatological or systemic disorder which would interfere with the results
* Free of any acute or chronic disease
* Will complete a preliminary medical history form and are in general good health
* Can read, understand, and sign informed consent

Exclusion Criteria

* Under 18 years old
* Currently under doctor's care
* Currently taking any medication
* History of acute or chronic disease
* Diagnosed with chronic skin allergies
* Pregnant or lactating
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mayya Tastene, MD

Role: PRINCIPAL_INVESTIGATOR

AMA Laboratories

Locations

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AMA Laboratories, Inc.

New City, New York, United States

Site Status

Countries

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United States

Other Identifiers

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GLI.04.SRE.US10235

Identifier Type: -

Identifier Source: org_study_id

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