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
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Controlled Study of the Efficacy of NdYag for Acne Keloidalis Nuchae

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: September 2008
Estimated Study Completion Date: December 2013
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757315

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

Additional Information:
Publications:
Responsible Party: Iltefat Hamzavi, Dermatologist, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00757315     History of Changes
Other Study ID Numbers: 5244
Study First Received: September 22, 2008
Last Updated: March 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Henry Ford Health System:
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

Additional relevant MeSH terms:
Acne Vulgaris
Acne Keloid
Dermatitis
Folliculitis
Keloid
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Collagen Diseases
Connective Tissue Diseases
Hair Diseases
Cicatrix
Fibrosis
Pathologic Processes
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014