- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01328080
Treatment of Acne Keloidalis Nuchae (Razor Bumps Behind the Neck) Using UV Light Therapy
February 28, 2017 updated by: Ginette Okoye, MD, Johns Hopkins University
Improving Acne Keloidalis Nuchae by Inducing Matrix Metalloproteinases in Vivo Using Targeted Ultraviolet-B Irradiation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Dept. of Dermatology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Targeted UV-B (Left)
Targeted UV-B on left side of the scalp.
|
Daavlin Lumera phototherapy device (290-320 nm), dosed by patients' individual minimal erythema dose (MED)
|
Experimental: Targeted UV-B (Right)
Targeted UV-B on right side of the scalp.
|
Daavlin Lumera phototherapy device (290-320 nm), dosed by patients' individual minimal erythema dose (MED)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage Change in Total AKN Lesions From Baseline to Week 16.
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
March 31, 2011
First Submitted That Met QC Criteria
April 1, 2011
First Posted (Estimate)
April 4, 2011
Study Record Updates
Last Update Posted (Actual)
March 29, 2017
Last Update Submitted That Met QC Criteria
February 28, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00035842
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acne Keloidalis Nuchae
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Henry Ford Health SystemUnknownAcne Keloidalis Nuchae | NdYag Laser | AKN | Acne Keloidalis | AK | Dermatitis Papillaris Capillitii | Folliculitis Keloidalis Nuchae | Sycosis Nuchae | Acne Keloid | Keloidal Folliculitis | Lichen Keloidalis Nuchae | Folliculitis Nuchae Scleroticans | Sycosis FramboesiformisUnited States
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Cairo UniversityCompleted
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Icahn School of Medicine at Mount SinaiBausch Health Americas, Inc.Recruiting
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Erasmus Medical CenterCompletedAcne Keloidalis Nuchae | TattooNetherlands
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University of MichiganTerminatedScars | Keloid | Scleroderma | Granuloma Annulare | Acne Keloidalis NuchaeUnited States
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ProgenaBiomeRecruitingAcne Vulgaris | Acne | Acne Rosacea | Acne Inversa | Acne Keloidalis | Acne Keloid | Acne Conglobata | Acne Cystic | Acne Pomade | Acne Indurata | Acne Papular | Acne Tropica | Acne Urticata | Acne Fulminans | Acne Follicular | Acne Tropicalis | Acne Detergicans | Acne Iodide | Acne VarioliformisUnited States
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University of MichiganCompletedScleroderma, Localized | Scars | Keloid | Granuloma Annulare | Acne KeloidalisUnited States
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Technische Universität DresdenUnknown
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Chulalongkorn UniversityCompletedPost - Adolescence AcneThailand
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National Yang Ming UniversityTaipei City HospitalUnknown
Clinical Trials on Targeted UV-B
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University of MichiganArchimedes Innovations, PbcActive, not recruitingHealthy VolunteersUnited States
-
The Catholic University of KoreaUnknownVitiligo | Phototherapy | Maintenance Therapy | Narrow-band UV-BKorea, Republic of
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National Institute of Arthritis and Musculoskeletal...Completed
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Spirig Pharma Ltd.CompletedCutaneous Lupus ErythematosusGermany
-
Temple UniversityNational Institute of Allergy and Infectious Diseases (NIAID)RecruitingDiarrhea | Respiratory Viral Infection | Gastrointestinal Infection | Waterborne DiseasesUnited States
-
University of MinnesotaCompletedProteomicsUnited States
-
Emergent BioSolutionsQuintiles, Inc.; Unither VirologyCompleted
-
University of Colorado, DenverCompletedNevi and MelanomasUnited States
-
Denver Health and Hospital AuthorityJohns Hopkins University; University of Cincinnati; Alameda County Medical CenterCompletedRapid HIV ScreeningUnited States
-
University of Colorado, DenverWithdrawn