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NdYag Laser for Acne Keloidalis Nuchae

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00757315
Recruitment Status : Unknown
Verified March 2013 by Iltefat Hamzavi, Henry Ford Health System.
Recruitment status was:  Active, not recruiting
First Posted : September 23, 2008
Last Update Posted : March 29, 2013
Sponsor:
Information provided by (Responsible Party):
Iltefat Hamzavi, Henry Ford Health System

Tracking Information
First Submitted Date  ICMJE September 22, 2008
First Posted Date  ICMJE September 23, 2008
Last Update Posted Date March 29, 2013
Study Start Date  ICMJE September 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2010)
  • Treatment tolerability as measured by 0 to 10 pain scale [ Time Frame: 6 months ]
  • treatment safety [ Time Frame: 6 months ]
    This will be assessed by the frequency of adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2008)
  • treatment tolerabilty [ Time Frame: 6 months ]
  • treatment safety [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NdYag Laser for Acne Keloidalis Nuchae
Official Title  ICMJE Prospective, Controlled Study of the Efficacy of NdYag for Acne Keloidalis Nuchae
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acne Keloidalis Nuchae
  • NdYag Laser
  • AKN
  • Acne Keloidalis
  • AK
  • Dermatitis Papillaris Capillitii
  • Folliculitis Keloidalis Nuchae
  • Sycosis Nuchae
  • Acne Keloid
  • Keloidal Folliculitis
  • Lichen Keloidalis Nuchae
  • Folliculitis Nuchae Scleroticans
  • Sycosis Framboesiformis
Intervention  ICMJE
  • Device: NdYag Laser(hair removal laser) plus topical corticosteroid
    NdYag laser and topical corticosteroid are applied to one half of the scalp.
    Other Name: triamcinolone
  • Drug: Topical corticosteroid alone
    topical corticosteroid alone is applied to one half of the scalp
    Other Name: Triamcinolone
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Device: NdYag Laser(hair removal laser) plus topical corticosteroid
  • Active Comparator: 2
    Intervention: Drug: Topical corticosteroid alone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: September 4, 2012)
20
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2008)
30
Estimated Study Completion Date  ICMJE December 2013
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00757315
Other Study ID Numbers  ICMJE 5244
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Iltefat Hamzavi, Henry Ford Health System
Study Sponsor  ICMJE Henry Ford Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Iltefat H Hamzavi, MD Henry Ford Health Systems Dermatology Department
PRS Account Henry Ford Health System
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP