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NdYag Laser for Acne Keloidalis Nuchae

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Drug: Topical corticosteroid alone Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Controlled Study of the Efficacy of NdYag for Acne Keloidalis Nuchae
Study Start Date : September 2008
Actual Primary Completion Date : September 2009
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arms and Interventions
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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 Name: triamcinolone
Active Comparator: 2 Drug: Topical corticosteroid alone
topical corticosteroid alone is applied to one half of the scalp
Other Name: Triamcinolone


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Treatment tolerability as measured by 0 to 10 pain scale [ Time Frame: 6 months ]
  2. treatment safety [ Time Frame: 6 months ]
    This will be assessed by the frequency of adverse events


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT00757315


Locations
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United States, Michigan
Henry Ford Medical Center, New Center One
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Investigators
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Principal Investigator: Iltefat H Hamzavi, MD Henry Ford Health Systems Dermatology Department
More Information
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Publications:

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Responsible Party: Iltefat Hamzavi, Dermatologist, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00757315    
Other Study ID Numbers: 5244
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: March 29, 2013
Last Verified: March 2013
Keywords provided by Iltefat Hamzavi, Henry Ford Health System:
acne keloidalis nuchae
acne keloidalis
acne keloid
NdYag laser
AKN
AK
dermatitis papillaris capillitii
 folliculitis keloidalis nuchae
sycosis nuchae
keloidal folliculitis
lichen keloidalis nuchae
folliculitis nuchae scleroticans
sycosis framboesiformis
Additional relevant MeSH terms:
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Acne Vulgaris
Acne Keloid
Dermatitis
Keloid
Folliculitis
Skin Diseases
Acneiform Eruptions
Sebaceous Gland Diseases
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes
Hair Diseases
 Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action