NdYag Laser for Acne Keloidalis Nuchae

NCT ID: NCT00757315

Last Updated: 2013-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acne 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 Framboesiformis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

NdYag Laser(hair removal laser) plus topical corticosteroid

Intervention Type DEVICE

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

2

Group Type ACTIVE_COMPARATOR

Topical corticosteroid alone

Intervention Type DRUG

topical corticosteroid alone is applied to one half of the scalp

Interventions

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NdYag Laser(hair removal laser) plus topical corticosteroid

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

Intervention Type DEVICE

Topical corticosteroid alone

topical corticosteroid alone is applied to one half of the scalp

Intervention Type DRUG

Other Intervention Names

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triamcinolone Triamcinolone

Eligibility Criteria

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Inclusion Criteria

* For inclusion, the subject must:

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

Exclusion Criteria

* Subject must not:

1. Have AKN with a keloidal plaque \>3 cm in length
2. Be using any other medications or undergoing any other procedures for the treatment of AKN
3. Have used any topical medications or undergone any procedures for the treatments of AKN within two weeks of study enrollment
4. Have used any oral medications for AKN within 4 weeks of study enrollment:
5. Have serious, uncontrolled medical conditions
6. Be pregnant at any time during the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Iltefat Hamzavi

Dermatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iltefat H Hamzavi, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health Systems Dermatology Department

Locations

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Henry Ford Medical Center, New Center One

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15113285 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16394358 (View on PubMed)

Other Identifiers

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5244

Identifier Type: -

Identifier Source: org_study_id

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