NCT01548898

Brief Summary

Laser causes elimination and miniaturization of hair shafts that are the principal contributor to inflammation in Acne Keloidalis Nuchae (AKN).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2008

Typical duration for phase_4

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

January 1, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

Enrollment Period

2.3 years

First QC Date

February 29, 2012

Last Update Submit

March 6, 2012

Conditions

Acne Keloidalis Nuchae

Outcome Measures

Primary Outcomes (1)

  • Global response to treatment

    6 months

Secondary Outcomes (1)

  • Patient satisfaction

    6 months

Interventions

Nd-YAG laserDEVICE

All patients received 5 sessions (4 weeks apart) of long pulsed nd-YAG laser assisted hair removal on the affected area, emitting 1064 nm, with a fluence of 35-45 J/cm2 and pulse duration 10-30 msec adjusted to skin type and hair thickness. Laser was applied to all papules and plaques.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients suffering from AKN

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acne Keloid

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

KeloidCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAcneiform EruptionsSkin DiseasesFolliculitisHair Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Dermatology

Study Record Dates

First Submitted

February 29, 2012

First Posted

March 8, 2012

Study Start

January 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

March 8, 2012

Record last verified: 2012-03