NdYag Laser for Acne Keloidalis Nuchae | NCT00757315

Studies
NdYag Laser for Acne Keloidalis Nuchae

NCT00757315

Sponsor

Henry Ford Health System

Status

Unknown status

Last Update Posted

Mar 29, 2013Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

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

Interventions

NdYag Laser(hair removal laser) plus topical corticosteroid
Topical corticosteroid alone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Dec 2013Estimated

First Submitted Date

Sep 22, 2008

First Submission Date that Met QC Criteria

Sep 22, 2008

First Posted Date

Sep 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2013

Last Update Posted Date

Mar 29, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Conditions Module

Conditions

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

Keywords

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Device: NdYag Laser(hair removal laser) plus topical corticosteroid
2	Active Comparator		Drug: Topical corticosteroid alone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NdYag Laser(hair removal laser) plus topical corticosteroid	Device	NdYag laser and topical corticosteroid are applied to one half of the scalp.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Treatment tolerability as measured by 0 to 10 pain scale		6 months
treatment safety	This will be assessed by the frequency of adverse events	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Iltefat H Hamzavi, MD	Henry Ford Health Systems Dermatology Department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Henry Ford Medical Center, New Center One		Detroit	Michigan	48202	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15113285	Background	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.
16394358	Background	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.

Type	Date	Date Unknown
Release	Feb 15, 2022
Reset	Mar 9, 2022
Release	Jun 14, 2023

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 15, 2022			Mar 9, 2022
Jun 14, 2023			Jun 30, 2023
Oct 7, 2024			Oct 28, 2024
Nov 14, 2024			Dec 9, 2024
Feb 13, 2025			Feb 27, 2025
Mar 5, 2026			Mar 24, 2026
May 12, 2026			Jun 4, 2026

ID	Term
D007627	Keloid
D003095	Collagen Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D017486	Acneiform Eruptions
D012871	Skin Diseases
D005499	Folliculitis
D006201	Hair Diseases

ID	Term
D000305	Adrenal Cortex Hormones
D014221	Triamcinolone

ID	Term
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated