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Tolerability Comparison of Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT01046396
First received: January 8, 2010
Last updated: September 21, 2012
Last verified: September 2012
History of Changes
Results First Received: February 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Skin Manifestations
Interventions: Drug: adapalene cream 0.1% and adapalene lotion 0.1%
Drug: adapalene lotion 0.1%

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Dates of recruitment period: First subject was enrolled on January 11, 2010 and the last subject was enrolled on January 13, 2010.

Types of location: Investigative site was located at a research center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Wash-out period up to baseline for topical treatment on the treated area was less than 1 week for corticosteroids and/or 4 weeks for retinoids; for systemic treatment, it was less than 1 week for medications that may have increased photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids.

Reporting Groups
  Description
Differin® Cream 0.1% and Differin® Lotion 0.1% Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks; Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks

Participant Flow:   Overall Study
    Differin® Cream 0.1% and Differin® Lotion 0.1%  
STARTED     69  
COMPLETED     64  
NOT COMPLETED     5  
Withdrawal by Subject                 5  



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3.   [ Time Frame: baseline to week 3 ]
  Show Outcome Measure 1

2.  Secondary:   6 Question Subject Cosmetic Acceptability Questionnaire at Week 3   [ Time Frame: week 3 ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Ronald W. Gottschalk, MD / Medical Director
Organization: Galderma Laboratories, L.P.
phone: 817-961-5358
e-mail: ron.gottschalk@galderma.com


No publications provided


Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT01046396     History of Changes
Other Study ID Numbers: US10149
Study First Received: January 8, 2010
Results First Received: February 28, 2011
Last Updated: September 21, 2012
Health Authority: United States: Food and Drug Administration