NdYag Laser for Acne Keloidalis Nuchae

March 27, 2013 updated by: Iltefat Hamzavi, Henry Ford Health System

Prospective, Controlled Study of the Efficacy of NdYag for Acne Keloidalis Nuchae

Acne Keloidalis Nuchae (AKN) is a long standing hair follicle disease with bumps and scars on the skin of the back of the head and neck. The purpose of this new study is to determine how well a hair removal laser (NdYag Laser) works in treating AKN.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Medical Center, New Center One

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • For inclusion, the subject must:

    1. Be at least 18 years old
    2. Be otherwise healthy
    3. Have a diagnosis of AKN with at least 10 papules/pustules and/or a non-keloidal plaque > 7 cm2 in area.

Exclusion Criteria:

  • Subject must not:

    1. Have AKN with a keloidal plaque >3 cm in length
    2. Be using any other medications or undergoing any other procedures for the treatment of AKN
    3. Have used any topical medications or undergone any procedures for the treatments of AKN within two weeks of study enrollment
    4. Have used any oral medications for AKN within 4 weeks of study enrollment:
    5. Have serious, uncontrolled medical conditions
    6. Be pregnant at any time during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Device: NdYag Laser(hair removal laser) plus topical corticosteroid
NdYag laser and topical corticosteroid are applied to one half of the scalp.
Other Names:
  • triamcinolone
Active Comparator: 2
Drug: Topical corticosteroid alone
topical corticosteroid alone is applied to one half of the scalp
Other Names:
  • Triamcinolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
reduction in severity of AKN as measured by a novel AKN severity scoring system which incorporates number of lesions, size of lesions, type of lesions and associated inflammation.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment tolerability as measured by 0 to 10 pain scale
Time Frame: 6 months
6 months
treatment safety
Time Frame: 6 months
This will be assessed by the frequency of adverse events
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Investigators

  • Principal Investigator: Iltefat H Hamzavi, MD, Henry Ford Health Systems Dermatology Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

September 22, 2008

First Submitted That Met QC Criteria

September 22, 2008

First Posted (Estimate)

September 23, 2008

Study Record Updates

Last Update Posted (Estimate)

March 29, 2013

Last Update Submitted That Met QC Criteria

March 27, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5244

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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