NdYag Laser for Acne Keloidalis Nuchae

Acne Keloidalis Nuchae Clinical Trial

Official title:

Prospective, Controlled Study of the Efficacy of NdYag for Acne Keloidalis Nuchae

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00757315
• Other study ID #: 5244
• Status: Active, not recruiting
• Phase: N/A
• First received: September 22, 2008
• Last updated: March 27, 2013
• Start date: September 2008
• Est. completion date: December 2013

Study information

• Verified date: March 2013
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Keloid
• Acne Keloidalis
• Acne Keloidalis Nuchae
• Acne Vulgaris
• AK
• AKN
• Dermatitis
• Dermatitis Papillaris Capillitii
• Folliculitis
• Folliculitis Keloidalis Nuchae
• Folliculitis Nuchae Scleroticans
• Keloidal Folliculitis
• Lichen Keloidalis Nuchae
• NdYag Laser
• Sycosis Framboesiformis
• Sycosis Nuchae

Intervention

Device:
• NdYag Laser(hair removal laser) plus topical corticosteroid
NdYag laser and topical corticosteroid are applied to one half of the scalp.

Drug:
• Topical corticosteroid alone
topical corticosteroid alone is applied to one half of the scalp

Locations

Country	Name	City	State
United States	Henry Ford Medical Center, New Center One	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

References & Publications (2)

Battle EF Jr, Hobbs LM. Laser-assisted hair removal for darker skin types. Dermatol Ther. 2004;17(2):177-83. Review. — View Citation

Shah GK. Efficacy of diode laser for treating acne keloidalis nuchae. Indian J Dermatol Venereol Leprol. 2005 Jan-Feb;71(1):31-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Treatment tolerability as measured by 0 to 10 pain scale		6 months	No
Secondary	treatment safety	This will be assessed by the frequency of adverse events	6 months	Yes