Text Size

NdYag Laser for Acne Keloidalis Nuchae

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Iltefat Hamzavi, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT00757315
First received: September 22, 2008
Last updated: March 27, 2013
Last verified: March 2013
History of Changes

September 22, 2008
March 27, 2013
September 2008
September 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00757315 on ClinicalTrials.gov Archive Site
  • Treatment tolerability as measured by 0 to 10 pain scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • treatment safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    This will be assessed by the frequency of adverse events
  • treatment tolerabilty [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • treatment safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
NdYag Laser for Acne Keloidalis Nuchae
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • 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
  • 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
  • Experimental: 1
    Intervention: Device: NdYag Laser(hair removal laser) plus topical corticosteroid
  • Active Comparator: 2
    Intervention: Drug: Topical corticosteroid alone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
December 2013
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00757315
5244
No
Iltefat Hamzavi, Henry Ford Health System
Henry Ford Health System
Not Provided
Principal Investigator: Iltefat H Hamzavi, MD Henry Ford Health Systems Dermatology Department
Henry Ford Health System
March 2013

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