Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 29 of 142 for:    acne AND erythema

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

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.
ClinicalTrials.gov Identifier: NCT01328080
Recruitment Status : Completed
First Posted : April 4, 2011
Results First Posted : June 16, 2014
Last Update Posted : March 29, 2017
Sponsor:
Collaborator:
Skin of Color Society
Information provided by (Responsible Party):
Ginette Okoye, MD, Johns Hopkins University

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
Enrollment 11
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.
Arm/Group Title Targeted UVB Phototherapy
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 11 [1]
Completed 6
Not Completed 5
Reason Not Completed
Lost to Follow-up             5
[1]
11 subjects consented; 1 withdrew consent before first UVB treatment
Arm/Group Title Targeted UV-B
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
36.6  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
0
   0.0%
Male
11
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Percentage Change in Total AKN Lesions From Baseline to Week 16.
Hide Description To determine if treatment of AKN with targeted ultraviolet B radiation will improve the clinical appearance of lesions.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Targeted UVB Phototherapy
Hide Arm/Group Description:
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 Number of Participants Analyzed 6
Mean (Full Range)
Unit of Measure: percentage of lesion count reduction
49
(29 to 61)
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Targeted UVB Phototherapy
Hide Arm/Group Description 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.
All-Cause Mortality
Targeted UVB Phototherapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Targeted UVB Phototherapy
Affected / at Risk (%) # Events
Total   0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Targeted UVB Phototherapy
Affected / at Risk (%) # Events
Total   2/11 (18.18%)    
Skin and subcutaneous tissue disorders   
erythema * 1  2/11 (18.18%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, mild erythema
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
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