NdYag Laser for Acne Keloidalis Nuchae - Full Text View

Sponsored by:	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

MedlinePlus related topics: Acne

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospective, Controlled Study of the Efficacy of NdYag for Acne Keloidalis Nuchae

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 tolerabilty [ Time Frame: 6 months ] [ Designated as safety issue: No ]
treatment safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Device: NdYag Laser(hair removal laser) plus topical corticosteroid NdYag laser and topical corticosteroid are applied to one half of the scalp.
2: Active Comparator	Drug: Topical corticosteroid alone topical corticosteroid alone is applied to one half of the scalp

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

Contacts

Contact: Richard H Huggins, MD

313-916-6964

rhuggin1@hfhs.org

Locations

United States, Michigan
Henry Ford Medical Center, New Center One	Recruiting
Detroit, Michigan, United States, 48202
Contact: Richard H Huggins, MD 313-916-6964 rhuggin1@hfhs.org
Principal Investigator: Iltefat H Hamzavi, MD
Sub-Investigator: Richard H Huggins, MD
Sub-Investigator: Bassel H Mahmoud, MD, PhD
Sub-Investigator: Dakara Wright, MD
Sub-Investigator: Denise Woo, MD

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:	Henry Ford Hospital Department of Dermatology ( Iltefat H. Hamzavi MD )
Study ID Numbers:	5244
Study First Received:	September 22, 2008
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00757315 History of Changes
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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Facial Dermatoses
Skin Diseases
Facies
Collagen Diseases
Keloid
Hormone Antagonists
Acne Keloid
Hormones, Hormone Substitutes, and Hormone Antagonists
Triamcinolone diacetate
Sebaceous Gland Diseases

Hormones
Glucocorticoids
Acne Vulgaris
Triamcinolone hexacetonide
Exanthema
Triamcinolone Acetonide
Triamcinolone
Connective Tissue Diseases
Folliculitis
Dermatitis
Cicatrix

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Hair Diseases
Facial Dermatoses
Skin Diseases
Collagen Diseases
Keloid
Acne Keloid
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Sebaceous Gland Diseases
Hormones

Glucocorticoids
Pharmacologic Actions
Acne Vulgaris
Acneiform Eruptions
Therapeutic Uses
Triamcinolone
Connective Tissue Diseases
Folliculitis
Dermatitis
Cicatrix

ClinicalTrials.gov processed this record on May 07, 2009