Port Wine StainsPhase 2NCT00979550
The Effects of Aldara as an Adjunct to Laser Treatment
A Phase 2 study testing Imiquimod and non-medicated petroleum cream in people with Port Wine Stains, run by Henry Vasconez at 1 site in United States.
Trial summary
The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser treatment of vascular malformations. Read more about this study
- Who is it for?
- Ages 2 to 60 years
- Conditions the study is for
- Port Wine Stains
- What is being tested?
- Imiquimod and non-medicated petroleum cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Aug 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female patient between the ages of 2 and 60 years with a vascular malformation that is seeking cosmetic treatment.
- All races will be included as well as male and female.
- Clinical data on the usage of Aldara below the age of 2 years is limited and therefore all patients in the study will have to be at least 2 years of age.
- The majority of port wine stains are initially treated during childhood
- In order to determine the effectiveness of Aldara as an adjunct to laser therapy of Port Wine Stains, some of the patients in the study need to have lesions that have not undergone previous treatment.
Who cannot join
- Patients under the age of 2 or over the age of 60.
- Patients that have serious medical problems that would put them at risk of the anesthesia.
- Patients that have sensitivity reactions to the ingredients in the product including imiquimod, isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl alcohol, methylparaben, and propylparaben.
- Patients who are pregnant or have significant immunodeficiency or autoimmune diseases.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Division of Plastic Surgery
Lexington, Kentucky, 40536-0284
About this study
Official title: The Effects of Aldara as an Adjunct to Laser Treatment of Port Wine Stains
The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser treatment of vascular malformations.
Read the detailed description
This is a randomized, controlled, double-blinded study. Volunteers who are scheduled for laser treatment of Port Wine Stains will be screened and eligible subjects will be asked to participate. 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.
- Conditions
- Port Wine Stains
- Being tested
- Imiquimod, non-medicated petroleum cream
- Keywords
- laser, pediatric, skin pigmentation
- Medical subject headings
- Hemangioma, Capillary, Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImiquimodDrug
Also called Aldara
commercially available topical antiviral drug
non-medicated petroleum creamDrug
Over the counter topical cream used to aid the healing process in skin lesions
| Study group | Role | What they receive |
|---|---|---|
| Aldara cream | Experimental | Imiquimod (Aldara cream) will be applied nightly for four weeks after standard of care laser treatment for port wine stain. Receives: Drug: Imiquimod |
| non-medicated petroleum cream | Placebo comparator | Non-medicated petroleum cream will be applied nightly for four weeks after standard of care laser treatment for port wine stain. Receives: Drug: non-medicated petroleum cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Aldera Cream on the Reduction of Port Wine Stain (Vascular Malformation)
Lesions will be digitally photographed and its surface area measured by blinded observers using image analysis software
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startOct 2008
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: Failure to enroll enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Port Wine StainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Vasconez
- Sponsor type
- University, hospital or other
- Collaborators
- Graceway Pharmaceuticals, LLC
- Responsible party
- Sponsor-investigator, Henry Vasconez, University of Kentucky
- Investigators
- Henry C. Vasconez, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979550
- Sponsor's protocol ID
- UK Aldara
- Status last verified
- Mar 2018
- First submitted
- 17 Sep 2009
- Last updated
- 22 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Aldara as an Adjunct to Laser Treatment of Port Wine Stains
- ClinicalTrials.gov ID
- NCT00979550
- Acronym / sponsor ID
- UK Aldara
- Conditions
- Port Wine Stains
- Keywords
- laser, pediatric, skin pigmentation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to enroll enough participants
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Henry VasconezUniversity, hospital or other
- Collaborators
- Graceway Pharmaceuticals, LLC
- Study start
- Oct 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 18 Sep 2009 (estimated)
- Results
- Posted 22 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser treatment of vascular malformations.
Detailed description
This is a randomized, controlled, double-blinded study. Volunteers who are scheduled for laser treatment of Port Wine Stains will be screened and eligible subjects will be asked to participate. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aldara cream | Experimental | Drug: ImiquimodImiquimod (Aldara cream) will be applied nightly for four weeks after standard of care laser treatment for port wine stain. |
| non-medicated petroleum cream | Placebo comparator | Drug: non-medicated petroleum creamNon-medicated petroleum cream will be applied nightly for four weeks after standard of care laser treatment for port wine stain. |
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male or female patient between the ages of 2 and 60 years with a vascular malformation that is seeking cosmetic treatment.
- All races will be included as well as male and female.
- Clinical data on the usage of Aldara below the age of 2 years is limited and therefore all patients in the study will have to be at least 2 years of age.
- The majority of port wine stains are initially treated during childhood
- In order to determine the effectiveness of Aldara as an adjunct to laser therapy of Port Wine Stains, some of the patients in the study need to have lesions that have not undergone previous treatment.
Key exclusion criteria (4 listed)
- Patients under the age of 2 or over the age of 60.
- Patients that have serious medical problems that would put them at risk of the anesthesia.
- Patients that have sensitivity reactions to the ingredients in the product including imiquimod, isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl alcohol, methylparaben, and propylparaben.
- Patients who are pregnant or have significant immunodeficiency or autoimmune diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImiquimodAlso: Aldaracommercially available topical antiviral drug | Drug | Aldara cream |
| non-medicated petroleum creamOver the counter topical cream used to aid the healing process in skin lesions | Drug | non-medicated petroleum cream |
Primary outcome
Effects of Aldera Cream on the Reduction of Port Wine Stain (Vascular Malformation)
Time frame: 3 months
Lesions will be digitally photographed and its surface area measured by blinded observers using image analysis software
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry C. Vasconez, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imiquimod and non-medicated petroleum cream in people with Port Wine Stains, run by Henry Vasconez at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of Aldera Cream on the Reduction of Port Wine Stain (Vascular Malformation) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.