NCT01892410

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 4, 2013

Completed
Last Updated

July 29, 2022

Status Verified

June 1, 2013

Enrollment Period

1 month

First QC Date

June 25, 2013

Last Update Submit

July 28, 2022

Conditions

Skin Irritation

Outcome Measures

Primary Outcomes (1)

  • Area of irritation measured to determine sensitivity

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

    3 weeks

Study Arms (1)

Cetaphil Restoraderm Skin Restoring Body Wash

EXPERIMENTAL

All subjects receive Cetaphil Daily Advance Ultra Hydrating Lotion

Other: Cetaphil Restoraderm Skin Restoring Body Wash

Interventions

Cetaphil Restoraderm Skin Restoring Body WashOTHER

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

Cetaphil Restoraderm Skin Restoring Body Wash

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AMA Laboratories, Inc.

New City, New York, 10956, United States

Location

Study Officials

  • Mayya Tastene, MD

    AMA Laboratories

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2013

First Posted

July 4, 2013

Study Start

December 1, 2012

Primary Completion

January 1, 2013

Last Updated

July 29, 2022

Record last verified: 2013-06

Locations

US(1)