NCT02996097.

Study name	Fractional laser assisted steroid therapy versus intralesional steroids in the treatment of keloids
Methods	Study design: randomised controlled trial Duration of the study: 16 weeks Details of trial registration: NCT02996097 Funding sources: none declared
Participants	Number of participants assigned: 30 participants/lesions. 2 keloids on each participant will be selected as treatment sites Inclusion criteria: Males or females older than 17 at the screening visit with keloid scars; Healthy, as determined by the investigator based on a medical evaluation including medical history; Has at least 2 keloids of comparative size and texture located on the same general anatomic location (trunk or back); Is willing and able to comply with the requirements of the protocol. In particular, participant must adhere to the visits schedule and concomitant therapy; The participant is willing to comply with the 4‐week washout period. Exclusion criteria: The participant has an underlying known disease, a surgical or medical condition that in the opinion of the investigator might put the subject at risk; The participant is pregnant or breastfeeding at the time of enrolment or is planning to become pregnant at any point during the study period; The participant has a past history of coagulopathy; The participant has an underlying dermatological disease that in the opinion of the investigator could interfere with the study evaluations; The participant 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 participant is treated with anticoagulants or antiplatelet therapies; The participant has a known allergy or sensitivity to any local anaesthetic drug (e.g. EMLA or tetracaine 7 % / lidocaine 23 %) or a local antiseptic planned to be used for the laser; The participant is in an exclusion period from a previous study or is participating in another clinical trial; The participant is an adult under guardianship or is hospitalised in a public or private institution, or is deprived of freedom; The participant is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function. Age: > 18 years old Gender: 15 female and 15 male
Interventions	Intervention 1: CO2 ablative laser plus intralesional triamcinolone acetonide: a topical eutectic mixture of local aesthetics (EMLA) cream or tetracaine 7% / lidocaine 23% will be applied to the both treatment sites and after sufficient anaesthesia is attained, 1 keloid will be treated with the fractional CO2 laser using standard protocol as practised 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. Intervention 2: intralesional triamcinolone acetonide alone: a topical EMLA cream or tetracaine 7% / lidocaine 23% will be applied to the both treatment sites and after sufficient anaesthesia is attained, 1 keloid will be treated with the fractional CO2 laser using standard protocol as practised in our clinics followed by intralesional triamcinolone acetonide. The other chosen lesion would be treated with intralesional triamcinolone acetonide alone at 4‐week intervals.
Outcomes	Primary outcomes: mean change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS) and mean change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS)
Starting date	Not reported
Contact information	Dr. Ginette Okoye: ginette.okoye@howard.edu
Notes	Although the authors report the results in clinicaltrials.gov, no information on the time points and details of the assessments are available. We have contacted study authors, but did not have any response.