Excimer Laser, Serum Markers & Psoriasis

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala

Ingia / Ingia

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HaliImekamilika

Wadhamini

University Hospitals Cleveland Medical Center

Washirika

Photomedex

JARIBIO LA KLINIKI: NCT02165657

BioSeek: nct02165657

Maneno muhimu

Kikemikali

The overall aims for this study are to determine whether UVB excimer laser treatment of psoriasis affects serum inflammatory markers, and to assess hyperpigmentation and erythema with excimer laser treatment.

The investigators hypothesize that treatment of psoriasis with UVB delivered via 308 nm excimer laser will decrease the levels of serum inflammatory markers. The investigators hypothesize that treatment will decrease plaque erythema and will result in minimal hyperpigmentation.

Maelezo

Subjects will undergo Excimer treatment twice a week until they reach a PASI 75 improvement, or until they reach the maximum of 20 total treatments. A blood draw to assess serum inflammatory markers will be performed at the screening visit and final visit. Chromameter assessment, photographs, PASI and PGA (Physician Global Assessment) will be performed throughout the study to monitor psoriasis improvement, hyperpigmentation and erythema.

Tarehe

Imethibitishwa Mwisho:	04/30/2017
Iliyowasilishwa Kwanza:	06/12/2014
Uandikishaji uliokadiriwa Uliwasilishwa:	06/15/2014
Iliyotumwa Kwanza:	06/16/2014
Sasisho la Mwisho Liliwasilishwa:	05/11/2017
Sasisho la Mwisho Lilichapishwa:	05/14/2017
Tarehe halisi ya kuanza kwa masomo:	08/31/2013
Tarehe ya Kukamilisha Msingi iliyokadiriwa:	02/28/2017
Tarehe ya Kukamilisha Utafiti:	02/28/2017

Hali au ugonjwa

Psoriasis

Uingiliaji / matibabu

Device: Excimer laser

Awamu

Vikundi vya Arm

Mkono	Uingiliaji / matibabu
Experimental: Excimer laser Excimer laser treatment	Device: Excimer laser Excimer laser irradiation twice a week for up to 20 treatments.

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza	18 Years Kwa 18 Years
Jinsia Inastahiki Kujifunza	All
Hupokea Wajitolea wa Afya	Ndio
Vigezo	Inclusion Criteria: - Age 18 years and older - Male or female with diagnosis of psoriasis - Psoriasis involvement of 5-15% BSA - Has been off systemic psoriasis therapies (e.g. retinoids, methotrexate, biologic agents, etc) for at least 4 weeks - Has been off topical therapies (e.g. calcipotriene, topical steroids) for at least 2 weeks - Fitzpatrick Skin Types I-VI Exclusion Criteria: - Active history of photosensitivity (e.g. xeroderma pigmentosum, lupus erythematosus, porphyria, severe polymorphous light eruption, solar urticaria) - Any suspicion that the psoriasis is of the photosensitive variant. - Any medical condition that could be aggravated or may cause extreme discomfort during the study period.

Matokeo

Hatua za Matokeo ya Msingi

1. Change in serum inflammatory markers [23 visits (~12 weeks)]

Change in CRP, MPO, S100 and Resistin levels from screening to final visit.

Hatua za Matokeo ya Sekondari

1. Objective measure of hyperpigmentation [23 visits (~12 weeks)]

Chromameter Assessment to measure hyperpigmentation. L* values are measured with a chromameter. A lower L* means more hyperpigmentation.

2. Objective measure of erythema [23 visits (~12 weeks)]

Chromameter Assessment to measure erythema. a* values are measured with a chromameter. A higher a* means more erythema.

3. Improvement in Psoriasis based on PASI assessment [23 visits (~12 weeks)]

PASI will be performed throughout the study to assess response to treatment.

4. Improvement in psoriasis based on PGA [23 visits (~12 weeks)]

PGA (Physician Global Assessment) will be performed throughout the study to assess response to treatment.

Excimer Laser, Serum Markers & Psoriasis

Maneno muhimu

inflammation

erythema

hyperpigmentation

psoriasis