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Electrocautery vs Q-switch for Seborrheic Keratosis

Sponsor
Northwestern University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02366559
Collaborator
(none)
0
Enrollment
2
Arms
16
Duration (Months)

Study Details

Study Description

Brief Summary

The primary objective of this study is to compare the efficacy and risk of adverse events of electrocautery versus 532 nm Q-switched neodymium-doped yttrium aluminium garnet (Nd:YAG) laser for the treatment of flat seborrheic keratoses.

This study is a pilot study designed to determine feasibility of these procedures.

Condition or Disease Intervention/Treatment Phase
  • Device: Hyfrecator
  • Device: 532 nm Q-switched Nd:YAG laser
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparing the Efficacy and Risk of Adverse Events of Electrocautery Versus 532 nm Qswitched Neodymium-doped Yttrium Aluminium Garnet Laser for the Treatment of Flat Seborrheic Keratoses: A Randomized Control Trial
Study Start Date :
Aug 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: electrocautery

Blocks of subjects' lesions will be randomized 1:1 to receive electrocautery or 532 nm Nd:YAG laser. Prior to treatment with either electrocautery or 532nm Q-switched Nd:YAG laser, a topical EMLA cream will be applied to the lesions for at least 60 minutes under occlusion at the area of treatment.

Device: Hyfrecator
Active Comparator: 532 nm Nd:YAG laser

Blocks of subjects' lesions will be randomized 1:1 to receive electrocautery or 532 nm Nd:YAG laser. Prior to treatment with either electrocautery or 532nm Q-switched Nd:YAG laser, a topical EMLA cream will be applied to the lesions for at least 60 minutes under occlusion at the area of treatment.

Device: 532 nm Q-switched Nd:YAG laser

Outcome Measures

Primary Outcome Measures

  1. Change in Pigmentation from baseline to week 18 [Baseline and 18 weeks]

    Blinded photo raters will the lesion pigmentation on a scale of -50 (most hypopigmented relative to baseline) to +50 (most hyperpigmented relative to baseline) for both treatments.

  2. Change in lesion texture from baseline to week 18 [Baseline and 18 weeks]

    Blinded photo raters will the lesion texture on a scale of -50 (most worsening relative to baseline) to +50 (most improvement relative to baseline) for both treatments.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Subjects are Caucasian or Asian.

  2. Subjects who are between 18-65 year olds.

  3. Subjects have flat or macular seborrheic keratosis on dorsum of the hands and wrists, extensor surfaces of the forearms. The diagnosis of flat seborrheic keratosis is confirmed by two clinical dermatologists using routine clinical examination and dermoscopy.

  4. Subjects have Fitzpatrick skin type I-III.

  5. Subjects are in good health.

  6. Subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.

Exclusion Criteria:

  1. History of keloids or hypertrophic scars.

  2. Pregnant or lactating or intends to become pregnant in the next 3 months.

  3. Active skin disease or skin infection in the treatment area.

  4. Previous history of lidocaine allergy.

  5. History of methemoglobinemia

  6. Unable to understand the protocol or to give informed consent.

  7. Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical study or would pose as an unacceptable risk to subject.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Northwestern University

Investigators

  • Principal Investigator: Murad Alam, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Murad Alam, Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University
ClinicalTrials.gov Identifier:
NCT02366559
Other Study ID Numbers:
  • STU105340
First Posted:
Feb 19, 2015
Last Update Posted:
Dec 6, 2021
Last Verified:
Dec 1, 2021
Additional relevant MeSH terms:
Keratosis, Actinic
Keratosis
Keratosis, Seborrheic

Study Results

No Results Posted as of Dec 6, 2021