NCT01328080

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 4, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

June 16, 2014

Completed
Last Updated

March 29, 2017

Status Verified

February 1, 2017

Enrollment Period

1.5 years

First QC Date

March 31, 2011

Results QC Date

April 21, 2014

Last Update Submit

February 28, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to Week 16

Study Arms (2)

Targeted UV-B (Left)

EXPERIMENTAL

Targeted UV-B on left side of the scalp.

Radiation: Targeted UV-B

Targeted UV-B (Right)

EXPERIMENTAL

Targeted UV-B on right side of the scalp.

Radiation: Targeted UV-B

Interventions

Targeted UV-BRADIATION

Daavlin Lumera phototherapy device (290-320 nm), dosed by patients' individual minimal erythema dose (MED)

Targeted UV-B (Left)Targeted UV-B (Right)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 or over
  • male gender
  • African-American or other black ethnicity
  • current diagnosis of acne keloidalis nuchae (razor bumps on back of neck)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Dept. of Dermatology

Baltimore, Maryland, 21287, United States

Location

Related Links

MeSH Terms

Conditions

Acne Keloid

Condition Hierarchy (Ancestors)

KeloidCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAcneiform EruptionsSkin DiseasesFolliculitisHair Diseases

Results Point of Contact

Title
Ginette Okoye, MD, Director of Ethnic Skin Program
Organization
Johns Hopkins Dermatology

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 31, 2011

First Posted

April 4, 2011

Study Start

February 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

March 29, 2017

Results First Posted

June 16, 2014

Record last verified: 2017-02

Locations