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Trial record 25 of 32 for:    Stain | "Parkes Weber syndrome" OR "Vascular Malformations"

The Effects of Aldara as an Adjunct to Laser Treatment

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ClinicalTrials.gov Identifier: NCT00979550
Recruitment Status : Terminated (Failure to enroll enough participants)
First Posted : September 18, 2009
Results First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
Graceway Pharmaceuticals, LLC
Information provided by (Responsible Party):
Henry Vasconez, University of Kentucky

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Port Wine Stains
Interventions Drug: Imiquimod
Drug: non-medicated petroleum cream
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aldara Cream Non-medicated Petroleum Cream
Hide Arm/Group Description

The patients will be randomized and placed in the experimental or the control group. They will be given unlabeled sachets and instructed to apply the product each night to the right half of their treated lesion beginning the night after surgery for 4 weeks. Digital photographs of the Port Wine Stain will be taken prior to surgery and repeated at follow up appointments at 1 week, 1 month, 2 months, and 3 months after surgery. The photographs will be analyzed by blinded board certified plastic surgeons as well as a computer program.

Imiquimod (Aldara): .5 oz cream nightly to the affected area

The patients will be randomized and placed in the experimental or the control group. They will be given unlabeled sachets and instructed to apply the product each night to the right half of their treated lesion beginning the night after surgery for 4 weeks. Digital photographs of the Port Wine Stain will be taken prior to surgery and repeated at follow up appointments at 1 week, 1 month, 2 months, and 3 months after surgery. The photographs will be analyzed by blinded board certified plastic surgeons as well as a computer program.

non-medicated petroleum cream: .5 oz cream nightly to the affected area

Period Title: Overall Study
Started 4 3
Completed 4 3
Not Completed 0 0
Arm/Group Title Aldara Cream Non-medicated Petroleum Cream Total
Hide Arm/Group Description

The patients will be randomized and placed in the experimental or the control group. They will be given unlabeled sachets and instructed to apply the product each night to the right half of their treated lesion beginning the night after surgery for 4 weeks. Digital photographs of the Port Wine Stain will be taken prior to surgery and repeated at follow up appointments at 1 week, 1 month, 2 months, and 3 months after surgery. The photographs will be analyzed by blinded board certified plastic surgeons as well as a computer program.

Imiquimod (Aldara): .5 oz cream nightly to the affected area

The patients will be randomized and placed in the experimental or the control group. They will be given unlabeled sachets and instructed to apply the product each night to the right half of their treated lesion beginning the night after surgery for 4 weeks. Digital photographs of the Port Wine Stain will be taken prior to surgery and repeated at follow up appointments at 1 week, 1 month, 2 months, and 3 months after surgery. The photographs will be analyzed by blinded board certified plastic surgeons as well as a computer program.

non-medicated petroleum cream: .5 oz cream nightly to the affected area

Total of all reporting groups
Overall Number of Baseline Participants 4 3 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
<=18 years
4
 100.0%
3
 100.0%
7
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
Female
3
  75.0%
2
  66.7%
5
  71.4%
Male
1
  25.0%
1
  33.3%
2
  28.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 3 participants 7 participants
4 3 7
1.Primary Outcome
Title Effects of Aldera Cream on the Reduction of Port Wine Stain (Vascular Malformation)
Hide Description Lesions will be digitally photographed and its surface area measured by blinded observers using image analysis software
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aldara Cream Non-medicated Petroleum Cream
Hide Arm/Group Description:
Imiquimod (Aldara cream) will be applied nightly for four weeks after standard of care laser treatment for port wine stain.
Non-medicated petroleum cream will be applied nightly for four weeks after standard of care laser treatment for port wine stain.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aldara Cream Non-medicated Petroleum Cream
Hide Arm/Group Description Imiquimod (Aldara cream) will be applied nightly for four weeks after standard of care laser treatment for port wine stain. Non-medicated petroleum cream will be applied nightly for four weeks after standard of care laser treatment for port wine stain.
All-Cause Mortality
Aldara Cream Non-medicated Petroleum Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/3 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Aldara Cream Non-medicated Petroleum Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aldara Cream Non-medicated Petroleum Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/3 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Henry C. Vasconez, MD
Organization: University of Kentucky Healthcare
Phone: 8593236328
Responsible Party: Henry Vasconez, University of Kentucky
ClinicalTrials.gov Identifier: NCT00979550     History of Changes
Other Study ID Numbers: UK Aldara
First Submitted: September 17, 2009
First Posted: September 18, 2009
Results First Submitted: December 23, 2015
Results First Posted: March 22, 2018
Last Update Posted: March 22, 2018