NdYag Laser for Acne Keloidalis Nuchae - Full Text View

Sponsor:	Henry Ford Health System
Information provided by:	Henry Ford Health System
ClinicalTrials.gov Identifier:	NCT00757315

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:

MedlinePlus related topics: Acne

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide Corticosteroids

U.S. FDA Resources

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

Estimated Enrollment:	30
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2010
Estimated 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

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:

Henry Ford Dermatology Department Website This link exits the ClinicalTrials.gov site

Publications:

Battle EF Jr, Hobbs LM. Laser-assisted hair removal for darker skin types. Dermatol Ther. 2004;17(2):177-83. Review.

Shah GK. Efficacy of diode laser for treating acne keloidalis nuchae. Indian J Dermatol Venereol Leprol. 2005 Jan-Feb;71(1):31-4.

Responsible Party:	Iltefat H. Hamzavi MD, Henry Ford Hospital Department of Dermatology
ClinicalTrials.gov Identifier:	NCT00757315 History of Changes
Other Study ID Numbers:	5244
Study First Received:	September 22, 2008
Last Updated:	May 12, 2010
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 February 09, 2012