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Trial record 13 of 14 for:    "Keratosis seborrheic"

Electrocautery vs Q-switch for Seborrheic Keratosis

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ClinicalTrials.gov Identifier: NCT02366559
Recruitment Status : Withdrawn
First Posted : February 19, 2015
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

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
Keratosis, Seborrheic Device: Hyfrecator Device: 532 nm Q-switched Nd:YAG laser Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : August 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

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



Primary Outcome Measures :
  1. Change in Pigmentation from baseline to week 18 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02366559


Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Murad Alam, MD Northwestern University

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Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT02366559     History of Changes
Other Study ID Numbers: STU105340
First Posted: February 19, 2015    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
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Keratosis
Keratosis, Actinic
Keratosis, Seborrheic
Skin Diseases
Precancerous Conditions
Neoplasms