Back to resultsNdYag Laser for Acne Keloidalis Nuchae
Primary Purpose
Acne Keloidalis Nuchae, NdYag Laser, AKN
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NdYag Laser(hair removal laser) plus topical corticosteroid
Topical corticosteroid alone
Sponsored by
About this trial
This is an interventional treatment trial for Acne Keloidalis Nuchae focused on measuring 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
Eligibility Criteria
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.
Sites / Locations
- Henry Ford Medical Center, New Center One
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
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.
Secondary Outcome Measures
Treatment tolerability as measured by 0 to 10 pain scale
treatment safety
This will be assessed by the frequency of adverse events
Full Information
NCT ID
NCT00757315
First Posted
September 22, 2008
Last Updated
March 27, 2013
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT00757315
Brief Title
NdYag Laser for Acne Keloidalis Nuchae
Official Title
Prospective, Controlled Study of the Efficacy of NdYag for Acne Keloidalis Nuchae
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
NdYag Laser(hair removal laser) plus topical corticosteroid
Other Intervention Name(s)
triamcinolone
Intervention Description
NdYag laser and topical corticosteroid are applied to one half of the scalp.
Intervention Type
Drug
Intervention Name(s)
Topical corticosteroid alone
Other Intervention Name(s)
Triamcinolone
Intervention Description
topical corticosteroid alone is applied to one half of the scalp
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Treatment tolerability as measured by 0 to 10 pain scale
Time Frame
6 months
Title
treatment safety
Description
This will be assessed by the frequency of adverse events
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iltefat H Hamzavi, MD
Organizational Affiliation
Henry Ford Health Systems Dermatology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Medical Center, New Center One
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15113285
Citation
Battle EF Jr, Hobbs LM. Laser-assisted hair removal for darker skin types. Dermatol Ther. 2004;17(2):177-83. doi: 10.1111/j.1396-0296.2004.04018.x.
Results Reference
background
PubMed Identifier
16394358
Citation
Shah GK. Efficacy of diode laser for treating acne keloidalis nuchae. Indian J Dermatol Venereol Leprol. 2005 Jan-Feb;71(1):31-4. doi: 10.4103/0378-6323.13783.
Results Reference
background
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NdYag Laser for Acne Keloidalis Nuchae
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