Acne Keloidalis NuchaeNCT01328080
Treatment of Acne Keloidalis Nuchae (Razor Bumps Behind the Neck) Using UV Light Therapy
A study testing Targeted UV-B in people with Acne Keloidalis Nuchae, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Acne Keloidalis Nuchae
- What is being tested?
- Targeted UV-B
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 or over
- male gender
- African-American or other black ethnicity
- current diagnosis of acne keloidalis nuchae (razor bumps on back of neck)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Dept. of Dermatology
Baltimore, Maryland, 21287
About this study
Official title: 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.
- Conditions
- Acne Keloidalis Nuchae
- Being tested
- Targeted UV-B
- Medical subject headings
- Acne Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted UV-BRadiation
Daavlin Lumera phototherapy device (290-320 nm), dosed by patients' individual minimal erythema dose (MED)
| Study group | Role | What they receive |
|---|---|---|
| Targeted UV-B (Left) | Experimental | Targeted UV-B on left side of the scalp. Receives: Radiation: Targeted UV-B |
| Targeted UV-B (Right) | Experimental | Targeted UV-B on right side of the scalp. Receives: Radiation: Targeted UV-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acne Keloidalis NuchaeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Skin of Color Society
- Responsible party
- Principal investigator, Ginette Okoye, MD, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328080
- Sponsor's protocol ID
- NA_00035842
- Status last verified
- Feb 2017
- First submitted
- 31 Mar 2011
- Last updated
- 29 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Acne Keloidalis Nuchae by Inducing Matrix Metalloproteinases in Vivo Using Targeted Ultraviolet-B Irradiation
- ClinicalTrials.gov ID
- NCT01328080
- Acronym / sponsor ID
- NA_00035842
- Conditions
- Acne Keloidalis Nuchae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Skin of Color Society
- Study start
- Feb 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 4 Apr 2011 (estimated)
- Results
- Posted 16 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted UV-B (Left) | Experimental | Radiation: Targeted UV-BTargeted UV-B on left side of the scalp. |
| Targeted UV-B (Right) | Experimental | Radiation: Targeted UV-BTargeted UV-B on right side of the scalp. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 or over
- male gender
- African-American or other black ethnicity
- current diagnosis of acne keloidalis nuchae (razor bumps on back of neck)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted UV-BDaavlin Lumera phototherapy device (290-320 nm), dosed by patients' individual minimal erythema dose (MED) | Radiation | Targeted UV-B (Left), Targeted UV-B (Right) |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Skin of Color Society (sponsor)Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted UV-B in people with Acne Keloidalis Nuchae, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Total AKN Lesions From Baseline to Week 16. (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.