Acne Keloid, Acne Keloidalis, Acne Keloidalis Nuchae, AK, AKN, Dermatitis Papillaris Capillitii, Folliculitis Keloidalis Nuchae, Folliculitis Nuchae Scleroticans, Keloidal Folliculitis, Lichen Keloidalis Nuchae, NdYag Laser, Sycosis Framboesiformis, Sycosis Nuchae
Conditions
Keywords
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
Brief 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.
Interventions
DEVICENdYag Laser(hair removal laser) plus topical corticosteroid
NdYag laser and topical corticosteroid are applied to one half of the scalp.
DRUGTopical corticosteroid alone
topical corticosteroid alone is applied to one half of the scalp
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Treatment tolerability as measured by 0 to 10 pain scale | 6 months | — |
| treatment safety | 6 months | This will be assessed by the frequency of adverse events |
Countries
United States
Outcome results
None listed