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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01328080
Other study ID # NA_00035842
Secondary ID
Status Completed
Phase N/A
First received March 31, 2011
Last updated May 19, 2014
Start date February 2011
Est. completion date August 2012

Study information

Verified date May 2014
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Johns Hopkins Dept. of Dermatology Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University Skin of Color Society

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT00757315 - NdYag Laser for Acne Keloidalis Nuchae N/A
Recruiting NCT05608499 - Duobrii Treatment of Acne Keloidalis Nuchae (AKN) Phase 3
Completed NCT02372786 - 7% Lidocaine/7% Tetracaine Cream Versus 2,5% Lidocaine / 2,5% Prilocaine Cream Phase 4
Completed NCT01548898 - The Efficacy of Laser Assisted Hair Removal in the Treatment of Acne Keloidalis Nuchae; a Pilot Study Phase 4
Terminated NCT00476697 - UVA1 Light for Scleroderma and Similar Conditions N/A