Overview

This trial is active, not recruiting.

Conditions 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
Treatments ndyag laser(hair removal laser) plus topical corticosteroid, topical corticosteroid alone
Sponsor Henry Ford Health System
Start date September 2008
End date September 2009
Trial size 20 participants
Trial identifier NCT00757315, 5244

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
ndyag laser(hair removal laser) plus topical corticosteroid triamcinolone
NdYag laser and topical corticosteroid are applied to one half of the scalp.
(Active Comparator)
topical corticosteroid alone Triamcinolone
topical corticosteroid alone is applied to one half of the scalp

Primary Outcomes

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

Secondary Outcomes

Measure
Treatment tolerability as measured by 0 to 10 pain scale
time frame: 6 months
treatment safety
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Prospective, Controlled Study of the Efficacy of NdYag for Acne Keloidalis Nuchae
Principal investigator Iltefat H Hamzavi, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Henry Ford Health System.