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Clinical Trials/NCT01892410
NCT01892410CompletedNot Applicable

100 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Semi-Occlusive Patch)

Galderma R&D1 site in 1 country100 target enrollmentStarted: December 1, 2012Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Area of irritation measured to determine sensitivity
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Cetaphil Restoraderm Skin Restoring Body Wash

Experimental

All subjects receive Cetaphil Daily Advance Ultra Hydrating Lotion

Intervention: Cetaphil Restoraderm Skin Restoring Body Wash (Other)

Outcomes

Primary Outcomes

Area of irritation measured to determine sensitivity

Time Frame: 3 weeks

9 consecutive 24hr exposures for every Monday, Wednesday, and Friday for 3 consecutive weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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