Acne Keloidalis Nuchae
Conditions
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.
Interventions
RADIATIONTargeted UV-B
Daavlin Lumera phototherapy device (290-320 nm), dosed by patients' individual minimal erythema dose (MED)
Sponsors
Skin of Color Society
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from patient populations evaluated by the Johns Hopkins Department of Dermatology located at the Johns Hopkins Outpatient Center between April 2011 through April 2012. Participants were also be recruited from other patient populations at the Johns Hopkins Hospital through the use of advertisements.
Pre-assignment details
Prior to UVB treatment,each subject's Minimal Erythema dose (MED) was determined. Exclusion criteria: photosensitive disorders,skin cancer,previous radiation therapy,use of photosensitizing drugs,lidocaine allergy,bleeding disorders,pregnancy,and lactation. Wash out: 4 weeks for antibiotics/corticosteroids, 6 months for oral isotretinoin.
Participants by arm
| Arm | Count |
|---|---|
| Targeted UV-B | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
Baseline characteristics
| Characteristic | Targeted UV-B |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 36.6 years STANDARD_DEVIATION 6.6 |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
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.
Time frame: Baseline to Week 16
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Targeted UVB Phototherapy | Percentage Change in Total AKN Lesions From Baseline to Week 16. | 49 percentage of lesion count reduction |