Fractional Laser Assisted Steroid Therapy vs Intralesional Steroids in the Treatment of Keloids

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.

Inclusion Criteria:

- Male or female older than 18 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