Clinical trial · Interventional
The Effects of Aldara as an Adjunct to Laser Treatment
The Effects of Aldara as an Adjunct to Laser Treatment of Port Wine Stains
NCT00979550CI-TRIAL-00032207terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Failure to enroll enough participants
Summary
Brief summary (as posted)
The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser treatment of vascular malformations.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Port Wine Stains | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imiquimod | Drug | Imiquimod | ALIAS |
| non-medicated petroleum cream | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Aldara cream
- description
- Imiquimod (Aldara cream) will be applied nightly for four weeks after standard of care laser treatment for port wine stain.
- interventionNames
- Drug: Imiquimod
- type
- PLACEBO_COMPARATOR
- label
- non-medicated petroleum cream
- description
- Non-medicated petroleum cream will be applied nightly for four weeks after standard of care laser treatment for port wine stain.
- interventionNames
- Drug: non-medicated petroleum cream
Primary outcomes (1)
- measure
- Effects of Aldera Cream on the Reduction of Port Wine Stain (Vascular Malformation)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.