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A Clinical Study to Evaluate the Tolerability of a Topical Antibiotic and Retinoid Used in a Combined Regimen With a BPO Wash

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00891982
First received: April 29, 2009
Last updated: June 23, 2011
Last verified: June 2011
History of Changes
Results First Received: October 6, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: CTGel/ BPO Wash
Drug: Soap Free Cleanser and CTGel

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
CTGel Plus BPO Wash BPO Wash in the morning and CTGel in the evening
CTGel Soap Free Cleanser in the morning and CTGel in the evening
Total Total of all reporting groups

Baseline Measures
    CTGel Plus BPO Wash     CTGel     Total  
Number of Participants  
[units: participants]
 		  30     31     61  
Age  
[units: participants]
 		     
<18 years     16     14     30  
Between 18 and 45 years     14     17     31  
Gender  
[units: participants]
 		     
Female     18     20     38  
Male     12     11     23  
Ethnicity (NIH/OMB)  
[units: participants]
 		     
Hispanic or Latino     6     5     11  
Not Hispanic or Latino     24     26     50  
Race (NIH/OMB)  
[units: Participants]
 		     
Black or African American     2     3     5  
White     24     28     52  
More than one race     4     0     4  
Region of Enrollment  
[units: participants]
 		     
United States     30     31     61  
ISGA [1]
[units: participants]
 		     
Grade 2     9     11     20  
Grade 3     18     15     33  
Grade 4     3     5     8  
[1] Investigator's Static Global Assessment measured on a 6 point scale where 0=normal, clear skin; 1 = skin almost clear; 2 = Some noninflammatory lesions are present, with few inflammatory lesions; 3 = Noninflammatory lesions predominate, with multiple inflammatory lesions evident; 4 = Inflammatory lesions are more apparent: many comedones and papules/pustules,there may or may not be a few nodulocystic lesions; and 5=highly inflammatory lesions predominate.



  Outcome Measures
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1.  Primary:   Local Tolerability - Skin Dryness   [ Time Frame: Screening/baseline ]
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2.  Primary:   Local Tolerability - Skin Dryness   [ Time Frame: Week 1 ]
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3.  Primary:   Local Tolerability - Skin Dryness   [ Time Frame: Week 2 ]
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4.  Primary:   Local Tolerability - Skin Dryness   [ Time Frame: Week 4 ]
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5.  Primary:   Local Tolerability - Skin Scaling   [ Time Frame: Screening/baseline ]
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6.  Primary:   Local Tolerability - Skin Scaling   [ Time Frame: Week 1 ]
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7.  Primary:   Local Tolerability - Skin Scaling   [ Time Frame: Week 2 ]
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8.  Primary:   Local Tolerability - Skin Scaling   [ Time Frame: Week 4 ]
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9.  Primary:   Local Tolerability - Erythema (Redness)   [ Time Frame: Screening/baseline ]
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10.  Primary:   Local Tolerability - Erythema (Redness)   [ Time Frame: Week 1 ]
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11.  Primary:   Local Tolerability - Erythema (Redness)   [ Time Frame: Week 2 ]
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12.  Primary:   Local Tolerability - Erythema (Redness)   [ Time Frame: Week 4 ]
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13.  Secondary:   Subject Assessment of Burning/Stinging   [ Time Frame: Screening/baseline ]
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14.  Secondary:   Subject Assessment of Burning/Stinging   [ Time Frame: Week 1 ]
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15.  Secondary:   Subject Assessment of Burning/Stinging   [ Time Frame: Week 2 ]
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16.  Secondary:   Subject Assessment of Burning/Stinging   [ Time Frame: Week 4 ]
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17.  Secondary:   Subject Assessment of Itching   [ Time Frame: Screening/Baseline ]
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18.  Secondary:   Subject Assessment of Itching   [ Time Frame: Week 1 ]
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19.  Secondary:   Subject Assessment of Itching   [ Time Frame: Week 2 ]
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20.  Secondary:   Subject Assessment of Itching   [ Time Frame: Week 4 ]
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  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: Alessandra Alio
Organization: Stiefel, a GSK company
phone: 1 919 990-6122
e-mail: alessandra.b.alio@stiefel.com


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00891982     History of Changes
Other Study ID Numbers: 114679, W0265-306
Study First Received: April 29, 2009
Results First Received: October 6, 2010
Last Updated: June 23, 2011
Health Authority: United States: Food and Drug Administration