NdYag Laser for Acne Keloidalis Nuchae
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ClinicalTrials.gov Identifier: NCT00757315 |
Recruitment Status : Unknown
Verified March 2013 by Iltefat Hamzavi, Henry Ford Health System.
Recruitment status was: Active, not recruiting
First Posted : September 23, 2008
Last Update Posted : March 29, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
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 | Device: NdYag Laser(hair removal laser) plus topical corticosteroid Drug: Topical corticosteroid alone | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Prospective, Controlled Study of the Efficacy of NdYag for Acne Keloidalis Nuchae |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | September 2009 |
Estimated Study Completion Date : | December 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Device: NdYag Laser(hair removal laser) plus topical corticosteroid
NdYag laser and topical corticosteroid are applied to one half of the scalp.
Other Name: triamcinolone |
Active Comparator: 2 |
Drug: Topical corticosteroid alone
topical corticosteroid alone is applied to one half of the scalp
Other Name: Triamcinolone |
- 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. [ Time Frame: 6 months ]
- Treatment tolerability as measured by 0 to 10 pain scale [ Time Frame: 6 months ]
- treatment safety [ Time Frame: 6 months ]This will be assessed by the frequency of adverse events

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
For inclusion, the subject must:
- 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.
Exclusion Criteria:
-
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00757315
United States, Michigan | |
Henry Ford Medical Center, New Center One | |
Detroit, Michigan, United States, 48202 |
Principal Investigator: | Iltefat H Hamzavi, MD | Henry Ford Health Systems Dermatology Department |
Responsible Party: | Iltefat Hamzavi, Dermatologist, Henry Ford Health System |
ClinicalTrials.gov Identifier: | NCT00757315 |
Other Study ID Numbers: |
5244 |
First Posted: | September 23, 2008 Key Record Dates |
Last Update Posted: | March 29, 2013 |
Last Verified: | March 2013 |
acne keloidalis nuchae acne keloidalis acne keloid NdYag laser AKN AK dermatitis papillaris capillitii |
folliculitis keloidalis nuchae sycosis nuchae keloidal folliculitis lichen keloidalis nuchae folliculitis nuchae scleroticans sycosis framboesiformis |
Acne Vulgaris Acne Keloid Dermatitis Keloid Folliculitis Skin Diseases Acneiform Eruptions Sebaceous Gland Diseases Collagen Diseases Connective Tissue Diseases Cicatrix Fibrosis Pathologic Processes Hair Diseases |
Triamcinolone Triamcinolone Acetonide Triamcinolone hexacetonide Triamcinolone diacetate Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |