Back to resultsTreatment of Acne Keloidalis Nuchae (Razor Bumps Behind the Neck) Using UV Light Therapy
Primary Purpose
Acne Keloidalis Nuchae
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted UV-B
Sponsored by
About this trial
This is an interventional treatment trial for Acne Keloidalis Nuchae
Eligibility Criteria
Inclusion Criteria:
- age 18 or over
- male gender
- African-American or other black ethnicity
- current diagnosis of acne keloidalis nuchae (razor bumps on back of neck)
Exclusion Criteria:
- allergy to lidocaine or numbing medicine
- history of increased sensitivity to sunlight, lupus, or porphyria
- current use of a drug that increases sensitivity to sunlight
Sites / Locations
- Johns Hopkins Dept. of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Targeted UV-B (Left)
Targeted UV-B (Right)
Arm Description
Targeted UV-B on left side of the scalp.
Targeted UV-B on right side of the scalp.
Outcomes
Primary Outcome Measures
Percentage Change in Total AKN Lesions From Baseline to Week 16.
To determine if treatment of AKN with targeted ultraviolet B radiation will improve the clinical appearance of lesions.
Secondary Outcome Measures
Full Information
NCT ID
NCT01328080
First Posted
March 31, 2011
Last Updated
February 28, 2017
Sponsor
Johns Hopkins University
Collaborators
Skin of Color Society
1. Study Identification
Unique Protocol Identification Number
NCT01328080
Brief Title
Treatment of Acne Keloidalis Nuchae (Razor Bumps Behind the Neck) Using UV Light Therapy
Official Title
Improving Acne Keloidalis Nuchae by Inducing Matrix Metalloproteinases in Vivo Using Targeted Ultraviolet-B Irradiation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
Skin of Color Society
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is being done to evaluate the effect of targeted UV-B (a component of sunlight) on the treatment of acne keloidalis nuchae (AKN, or razor bumps on the back of the neck). The investigators believe targeted UV-B is a safe and effective way to reduce the appearance of AKN.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Keloidalis Nuchae
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Targeted UV-B (Left)
Arm Type
Experimental
Arm Description
Targeted UV-B on left side of the scalp.
Arm Title
Targeted UV-B (Right)
Arm Type
Experimental
Arm Description
Targeted UV-B on right side of the scalp.
Intervention Type
Radiation
Intervention Name(s)
Targeted UV-B
Intervention Description
Daavlin Lumera phototherapy device (290-320 nm), dosed by patients' individual minimal erythema dose (MED)
Primary Outcome Measure Information:
Title
Percentage Change in Total AKN Lesions From Baseline to Week 16.
Description
To determine if treatment of AKN with targeted ultraviolet B radiation will improve the clinical appearance of lesions.
Time Frame
Baseline to Week 16
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18 or over
male gender
African-American or other black ethnicity
current diagnosis of acne keloidalis nuchae (razor bumps on back of neck)
Exclusion Criteria:
allergy to lidocaine or numbing medicine
history of increased sensitivity to sunlight, lupus, or porphyria
current use of a drug that increases sensitivity to sunlight
Facility Information:
Facility Name
Johns Hopkins Dept. of Dermatology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.skinofcolorsociety.org/
Description
Skin of Color Society (sponsor)
Learn more about this trial
Treatment of Acne Keloidalis Nuchae (Razor Bumps Behind the Neck) Using UV Light Therapy
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