NdYag Laser for Acne Keloidalis Nuchae

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Controlled Study of the Efficacy of NdYag for Acne Keloidalis Nuchae

Conditions
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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

Intervention / Treatment
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* Device: NdYag Laser(hair removal laser) plus topical corticosteroid
* Drug: Topical corticosteroid alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For inclusion, the subject must: Be at least 18 years old Be otherwise healthy 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: Have AKN with a keloidal plaque >3 cm in length Be using any other medications or undergoing any other procedures for the treatment of AKN Have used any topical medications or undergone any procedures for the treatments of AKN within two weeks of study enrollment Have used any oral medications for AKN within 4 weeks of study enrollment: Have serious, uncontrolled medical conditions Be pregnant at any time during the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: NdYag Laser(hair removal laser) plus topical corticosteroid<br>* NdYag laser and topical corticosteroid are applied to one half of the scalp.<br>* Other names: triamcinolone;|
| Active Comparator: 2<br> | Drug: Topical corticosteroid alone<br>* topical corticosteroid alone is applied to one half of the scalp<br>* Other names: Triamcinolone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment tolerability as measured by 0 to 10 pain scale |  | 6 months | 
| treatment safety | This will be assessed by the frequency of adverse events | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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