NdYag Laser for Acne Keloidalis Nuchae

Not Applicable

• Conditions: NdYag Laser; Acne Keloidalis Nuchae; Dermatitis Papillaris Capillitii; Folliculitis Keloidalis Nuchae; AKN; AK; Acne Keloid; Keloidal Folliculitis; Acne Keloidalis; Lichen Keloidalis Nuchae
• Interventions: Drug: Topical corticosteroid alone; Device: NdYag Laser(hair removal laser) plus topical corticosteroid

• Registration Number: NCT00757315
• Lead Sponsor: Henry Ford Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-22
• Study First Submitted QC: 2008-09-22
• Study First Posted: 2008-09-23
• Primary Completion: 2009-09
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-27
• Last Update Posted: 2013-03-29
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Topical corticosteroid alone	-
1	NdYag Laser(hair removal laser) plus topical corticosteroid	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
treatment safety	6 months	This will be assessed by the frequency of adverse events
Treatment tolerability as measured by 0 to 10 pain scale	6 months

Trial Locations

Locations (1)

Henry Ford Medical Center, New Center One; 🇺🇸 Detroit, Michigan, United States