Fractional Laser Assisted Steroid Therapy vs Intralesional Steroids in the Treatment of Keloids
Keloid
About this trial
This is an interventional treatment trial for Keloid
Eligibility Criteria
Inclusion Criteria:
- Male or female older than 17 at the screening visit;
- The subject is healthy, as determined by the investigator based on a medical evaluation including medical history;
- The subject has at least two keloids of comparative size and texture located on the same general anatomic location (trunk or back);
- The subject is willing and able to comply with the requirements of the protocol. In particular, subject must adhere to the visits schedule and concomitant therapy. The subject is willing to comply with the 4 week washout period;
- The subject has understood and signed an Informed Consent Form approved by the Institutional Review Board (IRB) prior to any investigational procedure
Exclusion Criteria:
Any subject who is meeting one or more of the following exclusion criteria at the screening visit and/or at the baseline visit will not be included in this study:
- The subject has an underlying known disease, a surgical or medical condition that in the opinion of the investigator might put the subject at risk
- The subject is pregnant or breastfeeding at the time of enrollment or is planning to become pregnant at any point during the study period
- The subject has a past history of coagulopathy
- The subject has an underlying dermatological disease that in the opinion of the investigator could interfere with the study evaluations
- The subject has used prohibited topical or systemic treatments without sufficient protocol-defined wash-out period prior to Baseline (checked at Screening and Baseline) or is unwilling to refrain from use during the study
- The subject is treated with anticoagulants or antiplatelet therapies
- The subject has a known allergy or sensitivity to any local anesthetic drug (e.g. EMLA or tetracaine 7%/lidocaine 23%) or a local antiseptic planned to be used for the laser.
- The subject is in an exclusion period from a previous study or is participating in another clinical trial
- The subject is an adult under guardianship or is hospitalized in a public or private institution, or is deprived of freedom
- The subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function
Sites / Locations
- Johns Hopkins School of Medicine, Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
CO2 ablative laser plus intralesional triamcinolone acetonide
Intralesional triamcinolone acetonide alone
A topical eutectic mixture of local anesthetics (EMLA) cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide. One lesion would be treated with fractional CO2 ablative laser followed with intralesional triamcinolone acetonide at 4 weeks intervals
A topical EMLA cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide. The other chosen lesion would be treated with intralesional triamcinolone acetonide alone at 4 week intervals.