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| Name | Class |
|---|---|
| Skin of Color Society | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted UV-B (Left) | Experimental | Targeted UV-B on left side of the scalp. |
|
| Targeted UV-B (Right) | Experimental | Targeted UV-B on right side of the scalp. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted UV-B | Radiation | Daavlin Lumera phototherapy device (290-320 nm), dosed by patients' individual minimal erythema dose (MED) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Dept. of Dermatology | Baltimore | Maryland | 21287 | United States |
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| Label | URL |
|---|---|
| Skin of Color Society (sponsor) | View source |
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Targeted UVB Phototherapy | All patients were randomly assigned to receive targeted UVB phototherapy 3 times a week for 16 weeks to either the right or the left side of the scalp. The untreated side served as an internal control until the end of week 8, after which both sides of the scalp were treated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Targeted UV-B |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | percentage of lesion count reduction | Baseline to Week 16 |
|
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Targeted UVB Phototherapy | All patients were randomly assigned to receive targeted UVB phototherapy 3 times a week for 16 weeks to either the right or the left side of the scalp. The untreated side served as an internal control until the end of week 8, after which both sides of the scalp were treated. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| erythema | Skin and subcutaneous tissue disorders | mild erythema | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ginette Okoye, MD, Director of Ethnic Skin Program | Johns Hopkins Dermatology | 410-502-7546 | ctrep@jhmi.edu |
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| ID | Term |
|---|---|
| D000153 | Acne Keloid |
| ID | Term |
|---|---|
| D007627 | Keloid |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 11 |
| 2 |
| 11 |
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| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D005499 | Folliculitis |
| D006201 | Hair Diseases |