NCT00757315

Brief Summary

Acne Keloidalis Nuchae (AKN) is a long standing hair follicle disease with bumps and scars on the skin of the back of the head and neck. The purpose of this new study is to determine how well a hair removal laser (NdYag Laser) works in treating AKN.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

1 year

First QC Date

September 22, 2008

Last Update Submit

March 27, 2013

Conditions

Acne Keloidalis NuchaeNdYag LaserAKNAcne KeloidalisAKDermatitis Papillaris CapillitiiFolliculitis Keloidalis NuchaeSycosis NuchaeAcne KeloidKeloidal FolliculitisLichen Keloidalis NuchaeFolliculitis Nuchae ScleroticansSycosis Framboesiformis

Keywords

acne keloidalis nuchaeNdYag laserAKNacne keloidalisAKdermatitis papillaris capillitiifolliculitis keloidalis nuchaesycosis nuchaeacne keloidkeloidal folliculitislichen keloidalis nuchaefolliculitis nuchae scleroticanssycosis framboesiformis

Outcome Measures

Primary Outcomes (1)

  • reduction in severity of AKN as measured by a novel AKN severity scoring system which incorporates number of lesions, size of lesions, type of lesions and associated inflammation.

    6 months

Secondary Outcomes (2)

  • Treatment tolerability as measured by 0 to 10 pain scale

    6 months

  • treatment safety

    6 months

Study Arms (2)

1

EXPERIMENTAL
Device: NdYag Laser(hair removal laser) plus topical corticosteroid

2

ACTIVE COMPARATOR
Drug: Topical corticosteroid alone

Interventions

NdYag Laser(hair removal laser) plus topical corticosteroidDEVICE

NdYag laser and topical corticosteroid are applied to one half of the scalp.

Also known as: triamcinolone
1
Topical corticosteroid aloneDRUG

topical corticosteroid alone is applied to one half of the scalp

Also known as: Triamcinolone
2

Eligibility Criteria

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

You may qualify if:

  • Be at least 18 years old
  • Be otherwise healthy
  • Have a diagnosis of AKN with at least 10 papules/pustules and/or a non-keloidal plaque \> 7 cm2 in area.

You may not qualify if:

  • Subject must not:
  • Have AKN with a keloidal plaque \>3 cm in length
  • Be using any other medications or undergoing any other procedures for the treatment of AKN
  • Have used any topical medications or undergone any procedures for the treatments of AKN within two weeks of study enrollment
  • Have used any oral medications for AKN within 4 weeks of study enrollment:
  • Have serious, uncontrolled medical conditions
  • Be pregnant at any time during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Medical Center, New Center One

Detroit, Michigan, 48202, United States

Location

Related Publications (2)

  • Battle EF Jr, Hobbs LM. Laser-assisted hair removal for darker skin types. Dermatol Ther. 2004;17(2):177-83. doi: 10.1111/j.1396-0296.2004.04018.x.

    PMID: 15113285BACKGROUND

  • Shah GK. Efficacy of diode laser for treating acne keloidalis nuchae. Indian J Dermatol Venereol Leprol. 2005 Jan-Feb;71(1):31-4. doi: 10.4103/0378-6323.13783.

    PMID: 16394358BACKGROUND

MeSH Terms

Conditions

Acne Keloid

Interventions

Adrenal Cortex HormonesTriamcinolone

Condition Hierarchy (Ancestors)

KeloidCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAcneiform EruptionsSkin DiseasesFolliculitisHair Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone AntagonistsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Iltefat H Hamzavi, MD

    Henry Ford Health Systems Dermatology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dermatologist

Study Record Dates

First Submitted

September 22, 2008

First Posted

September 23, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2009

Study Completion

December 1, 2013

Last Updated

March 29, 2013

Record last verified: 2013-03

Locations

US(1)