Clinical trial NCT02996097: Fractional Laser Assisted Steroid Therapy vs Intralesional Steroids in the Treatment of Keloids
Official title: Fractional Laser Assisted Steroid Therapy vs Intralesional Steroids in the Treatment of Keloids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keloid
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of fractional carbon dioxide (CO2) laser therapy immediately followed by intralesional steroid therapy against intralesional steroid therapy alone for the treatment of keloids.

Detailed description: Intralesional corticosteroids remain the gold standard treatment for keloids. However, more effective therapies are desperately desired. Ablative fractional laser (AFL) treatment facilitates delivery of intralesional steroid more deeply and uniformly into the skin by creating vertical channels. Recent studies have showed that fractional laser assisted steroid therapy can be effective in the treatment of keloids. However the studies are lacking in comparing this treatment modality to the gold standard of intralesional steroids.

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

Primary outcomes:
measure: Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: Once every 4 weeks for 16 weeks
measure: Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: Once every 4 weeks for 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine, Department of Dermatology
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Ginette Okoye, MD
role: PRINCIPAL_INVESTIGATOR
References: