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Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks (Aldara)

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ClinicalTrials.gov Identifier: NCT00585247
Recruitment Status : Completed
First Posted : January 3, 2008
Results First Posted : April 4, 2018
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Port Wine Stain
Interventions: Drug: Imiquimod
Other: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Imiquimod

Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Imiquimod: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Healthy individuals with PWS (n = 14) were treated with PDL and then randomized to apply post treatment Imiquimod 5% cream for 8 weeks for 57 PWS sites (multiple sites per patient)

Placebo

Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Placebo: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Healthy individuals with PWS (n = 13) were treated with PDL and then randomized to apply post treatment placebo cream for 8 weeks for 57 PWS sites (multiple sites per patient)


Participant Flow:   Overall Study
    Imiquimod   Placebo
STARTED   14   13 
COMPLETED   14   13 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
27 subjects was enrolled to the study for 57 PWS sites (multiple sites per patient).

Reporting Groups
  Description
Imiquimod

Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Imiquimod: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks were treated with PDL and then randomized to apply post treatment imiquimod 5% cream for 8 weeks.

Placebo

Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Placebo: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks were treated with PDL and then randomized to apply post treatment placebo cream for 8 weeks.

Total Total of all reporting groups

Baseline Measures
   Imiquimod   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   13   27 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      4  28.6%      0   0.0%      4  14.8% 
Between 18 and 65 years      9  64.3%      13 100.0%      22  81.5% 
>=65 years      1   7.1%      0   0.0%      1   3.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7  50.0%      6  46.2%      13  48.1% 
Male      7  50.0%      7  53.8%      14  51.9% 
Region of Enrollment 
[Units: Participants]
     
United States   14   13   27 


  Outcome Measures

1.  Primary:   Change From Baseline in a* and E at 8 Weeks   [ Time Frame: 8 weeks baseline ]


  Serious Adverse Events


  Other Adverse Events


  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
Effects were evaluated after a single treatment and duration of effect is unknown


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Kristen Kelly
Organization: University of Ccalifornia, Irvine. Beckman Laser Institute
phone: 949.824.7997
e-mail: kmkelly@uci.edu


Publications of Results:

Responsible Party: Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00585247     History of Changes
Other Study ID Numbers: NIH-LAMMP-2006-4815
First Submitted: December 18, 2007
First Posted: January 3, 2008
Results First Submitted: August 25, 2015
Results First Posted: April 4, 2018
Last Update Posted: April 4, 2018