Improving Acne Keloidalis Nuchae by Inducing Matrix Metalloproteinases in Vivo Using Targeted Ultraviolet-B Irradiation
| Registry | NCT01328080 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, single group, masking: single, treatment |
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| Enrollment | 11 (Actual) |
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| Sponsor | Johns Hopkins University (Other); collaborators: Skin of Color Society |
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| Conditions | Acne Keloidalis Nuchae |
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| Interventions | Targeted UV-B (Radiation) |
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| Dates | start 2011-02-01, primary completion 2012-08-01, completion 2012-08-01, first posted 2011-04-04, last updated 2017-03-29 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Acne Keloidalis Nuchae All trials of Targeted UV-B
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Targeted UV-B (Left) | Experimental | Radiation: Targeted UV-B | Targeted UV-B on left side of the scalp. |
| Targeted UV-B (Right) | Experimental | Radiation: Targeted UV-B | Targeted UV-B on right side of the scalp. |
- Targeted UV-B (Radiation): Daavlin Lumera phototherapy device (290-320 nm), dosed by patients' individual minimal erythema dose (MED)
+Outcome measures
Primary outcomes
- Percentage Change in Total AKN Lesions From Baseline to Week 16. [Baseline to Week 16]: To determine if treatment of AKN with targeted ultraviolet B radiation will improve the clinical appearance of lesions.
+Eligibility
Sex: Male, ages: 18 Years to any
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
+Posted results
Participant flow
| Milestone | Targeted UVB Phototherapy |
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| Started | 11 |
| Completed | 6 |
| Not completed | 5 |
Outcome results
- Percentage Change in Total AKN Lesions From Baseline to Week 16. (Primary), Mean, percentage of lesion count reduction: Targeted UVB Phototherapy 49 (29 to 61)
Adverse events
Time frame: 16 weeks
| Arm | Deaths | Serious adverse events | Other adverse events |
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| Targeted UVB Phototherapy | 0 | 0/11 (0.0%) | 2/11 (18.2%) |
Other adverse events by term
| Term | Organ system | Targeted UVB Phototherapy |
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| erythema | Skin and subcutaneous tissue disorders | 2/11 |
+Locations (1)
| Facility | City | Country | Status |
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| Johns Hopkins Dept. of Dermatology | Baltimore, Maryland | United States | |