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

NCT02996097 | Completed Results

• 1 other identifier: IRB00082453
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Keloid

Outcome Measures

Primary Outcomes (2)

• Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS)

  Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score.

  Once every 4 weeks for 16 weeks

• Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS)

  Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score.

  Once every 4 weeks for 16 weeks

Study Arms (2)

CO2 ablative laser plus intralesional triamcinolone acetonide

EXPERIMENTAL

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

Device: The Lutronic electronic carbon dioxide (eCO2) Plus laser system; Drug: Intralesional Triamcinolone Acetonide

Intralesional triamcinolone acetonide alone

ACTIVE COMPARATOR

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.

Drug: Intralesional Triamcinolone Acetonide

Interventions

The Lutronic electronic carbon dioxide (eCO2) Plus laser system 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

CO2 ablative laser plus intralesional triamcinolone acetonide

Intralesional Triamcinolone Acetonide DRUG

CO2 ablative laser plus intralesional triamcinolone acetonide; Intralesional triamcinolone acetonide alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins School of Medicine, Department of Dermatology

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Keloid

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Ginette Okoye
• Organization: Johns Hopkins School of Medicine

ginette.okoye@howard.edu

9142158980

Study Officials

• Ginette Okoye, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 19, 2016
• Study Start: April 1, 2016
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: December 17, 2020
• Results First Posted: April 25, 2019

Record last verified: 2020-12

Locations

US (1)