Fractional Carbon Dioxide Laser Versus UVA 1 in Treatment of Localized Scleroderma

Localized Scleroderma Clinical Trial

Official title:

Fractional Carbon Dioxide Laser Versus UVA1 Phototherapy for Treatment of Localized Scleroderma: A Clinical & Immunohistochemical Comparative Study

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02002897
• Other study ID #: DDCU-24684
• Status: Unknown status
• Phase: N/A
• First received: September 5, 2013
• Last updated: September 9, 2014
• Start date: April 2013
• Est. completion date: December 2014

Study information

• Verified date: September 2014
• Source: Cairo University
• Contact: Suzan M Shalaby, Ass.lecturer
• Phone: 01224019459
• Email: suzanshalaby[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims at evaluating the efficacy of the fractional carbon dioxide laser as a new modality for treatment of localized scleroderma and to compare its results with the well established method of UVA 1 phototherapy.

Description:

The study includes 20 Cases presenting with one or more lesions of morphea (plaque, linear and atrophic). Each case will be subjected to:

1. -Informed consent. 2-Detailed history 3- Clinical examination to assess type, site, extent. 4-Clinical evaluation before treatment, in the follow up period and after treatment ( 24 sessions of UVA1) (one month after last CO2 laser session) using a scoring system:

• Skin thickness: 0-3, 0: normal; 1: thickened skin; 2: decreased ability to move the skin; 3: unable to pinch or move skin (according to the Modified Rodnan skin score)

• Dermal atrophy: 0-3, 0: none, 1: shiny, 2: visible vessels, 3: obvious atrophy

• Dyspigmentation (Hypo or hyper pigmentation): 0-3, 0: none, 1: mild, 2: moderate ,3: marked C- Digital Photography before, follow up and after treatment using the same digital camera , at fixed distance and constant settings for standardization .

5-Investigations: A- Punch biopsy: A punch biopsy will be taken before and after treatment to be stained with haematoxylin and eosin.

B-Immunohistochemical assessment of

• MMP1 (matrix metalloproteinase 1) in the pre and post treatment skin biopsies.

• TGFß ( transforming growth factor beta)in the pre and post treatment skin biopsies.

6-Treatment intervention: Two lesions with identical scoring will be chosen for the treatment interventions.

1. Lesion number (1) will be subjected to: localized UVA1 phototherapy (340-400 nm), low dose irradiation, at a rate of 3 sessions per week , total of 24 sessions with full clinical evaluation and investigations before and after treatment and clinical follow up one month after treatment.

2. Lesion number (2) will be subjected to: Fractional carbon dioxide laser (10,600 nm), a session once per month, total of 3 sessions with full clinical evaluation and investigations before and one month after the last session of treatment.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Types of morphea: plaque, linear and atrophic.

2. Patients are either new or discontinued systemic treatment for at least two months

Exclusion Criteria:

1. Morphea profunda and systemic scleroderma (diagnosed by: Rayaund's Phenomenon and sclerodactyly +/- internal organ affection)

2. Contraindications to phototherapy: eg: photosensitivity, systemic lupus, melanoma, skin cancer, or porphyria.

3. Contraindications to laser: Use of systemic retinoids in the last 6 months.

Related Conditions & MeSH terms

• Localized Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

Intervention

Device:
• Fractional carbon dioxide laser
Fractional carbon dioxide laser (10,600 nm), a session once per month, total of 3 sessions with full clinical evaluation and investigations before and one month after the last session of treatment.
• Ultraviolet A1 phototherapy (UVA1)
localized UVA1 phototherapy (340-400 nm), low dose irradiation, at a rate of 3 sessions per week , total of 24 sessions with full clinical evaluation and investigations before and after treatment and clinical follow up one month after treatment.

Locations

Country	Name	City	State
Egypt	Cairo University- Dermatology outpatient clinic	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Kineston D, Kwan JM, Uebelhoer NS, Shumaker PR. Use of a fractional ablative 10.6-µm carbon dioxide laser in the treatment of a morphea-related contracture. Arch Dermatol. 2011 Oct;147(10):1148-50. doi: 10.1001/archdermatol.2011.247. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessing the complications of each type of therapy	check list for each of common complications of Laser therapy & photo therapy is done for each patient.	4 months
Primary	Evaluation of the efficacy of fractional carbon dioxide laser as a new method for treatment of localized scleroderma	Efficacy will be evaluated by clinical assessment by blinded physician , biopsy before and after treatment for collagen assessment , Ultrasound bio-microscopy before and after treatment and patient satisfaction scores .	4 months
Secondary	Assessing the degree of improvement of cases of localized scleroderma using each method	Improvement will be evaluated by clinical assessment by blinded physician , biopsy before and after treatment for collagen assessment , Ultrasound bio-microscopy before and after treatment and patient satisfaction scores .	4 months