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

NCT ID: NCT02996097

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-06-15

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.

Conditions

Keloid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CO2 ablative laser plus intralesional triamcinolone acetonide

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

Group Type: EXPERIMENTAL

The Lutronic electronic carbon dioxide (eCO2) Plus laser system

Intervention Type: DEVICE

CO2 ablative laser plus intralesional triamcinolone acetonide 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. One lesion would be treated with fractional CO2 ablative laser followed with intralesional triamcinolone acetonide at 4 weeks intervals

Intralesional Triamcinolone Acetonide

Intervention Type: DRUG

Intralesional triamcinolone acetonide alone

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.

Group Type: ACTIVE_COMPARATOR

Intralesional Triamcinolone Acetonide

Intervention Type: DRUG

Interventions

The Lutronic electronic carbon dioxide (eCO2) Plus laser system

CO2 ablative laser plus intralesional triamcinolone acetonide 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. One lesion would be treated with fractional CO2 ablative laser followed with intralesional triamcinolone acetonide at 4 weeks intervals

Intervention Type: DEVICE

Intralesional Triamcinolone Acetonide

Intervention Type: DRUG

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ginette Okoye, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins School of Medicine, Department of Dermatology

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IRB00082453

Identifier Type: -

Identifier Source: org_study_id