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Treatment of Acne Keloidalis Nuchae (Razor Bumps Behind the Neck) Using UV Light Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01328080
First Posted: April 4, 2011
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Skin of Color Society
Information provided by (Responsible Party):
Ginette Okoye, MD, Johns Hopkins University
Results First Submitted: April 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Acne Keloidalis Nuchae
Intervention: Radiation: Targeted UV-B

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Targeted UVB Phototherapy
STARTED   11 [1] 
COMPLETED   6 
NOT COMPLETED   5 
Lost to Follow-up                5 
[1] 11 subjects consented; 1 withdrew consent before first UVB treatment



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Targeted UV-B No text entered.

Baseline Measures
   Targeted UV-B 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      11 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.6  (6.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      11 100.0% 
Region of Enrollment 
[Units: Participants]
 
United States   11 


  Outcome Measures

1.  Primary:   Percentage Change in Total AKN Lesions From Baseline to Week 16.   [ Time Frame: Baseline to Week 16 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ginette Okoye, MD, Director of Ethnic Skin Program
Organization: Johns Hopkins Dermatology
phone: 410-502-7546
e-mail: ctrep@jhmi.edu



Responsible Party: Ginette Okoye, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01328080     History of Changes
Other Study ID Numbers: NA_00035842
First Submitted: March 31, 2011
First Posted: April 4, 2011
Results First Submitted: April 21, 2014
Results First Posted: June 16, 2014
Last Update Posted: March 29, 2017