Trial Outcomes & Findings for Treatment of Acne Keloidalis Nuchae (Razor Bumps Behind the Neck) Using UV Light Therapy (NCT NCT01328080)
NCT ID: NCT01328080
Last Updated: 2017-03-29
Results Overview
To determine if treatment of AKN with targeted ultraviolet B radiation will improve the clinical appearance of lesions.
COMPLETED
NA
11 participants
Baseline to Week 16
2017-03-29
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
Baseline Characteristics
Treatment of Acne Keloidalis Nuchae (Razor Bumps Behind the Neck) Using UV Light Therapy
Baseline characteristics by cohort
| Measure |
Targeted UV-B
n=11 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
36.6 years
STANDARD_DEVIATION 6.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16To determine if treatment of AKN with targeted ultraviolet B radiation will improve the clinical appearance of lesions.
Outcome measures
| Measure |
Targeted UVB Phototherapy
n=6 Participants
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.
|
|---|---|
|
Percentage Change in Total AKN Lesions From Baseline to Week 16.
|
49 percentage of lesion count reduction
Interval 29.0 to 61.0
|
Adverse Events
Targeted UVB Phototherapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Targeted UVB Phototherapy
n=11 participants at risk
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.
|
|---|---|
|
Skin and subcutaneous tissue disorders
erythema
|
18.2%
2/11 • Number of events 2 • 16 weeks
|
Additional Information
Ginette Okoye, MD, Director of Ethnic Skin Program
Johns Hopkins Dermatology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place