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A randomized controlled study of low-dose UVA1, medium-dose UVA1, and narrowband UVB phototherapy in the treatment of localized scleroderma

https://doi.org/10.1016/j.jaad.2005.11.1063Get rights and content

Background

In previous trials, UV therapy has been demonstrated to be effective in the treatment of localized scleroderma (LS). To date, a randomized comparison study to evaluate the efficacy and safety of different, commonly used phototherapeutic modalities in LS is still outstanding.

Objective

The aim of this study was to compare the safety and efficacy of low-dose (LD) UVA1, medium-dose (MD) UVA1, and narrowband (NB) UVB phototherapy in the treatment of LS.

Methods

Sixty four patients with LS were consecutively included in a prospective, open, randomized controlled 3-arm study. Severity of LS was determined by means of a clinical score, and clinical improvement was also monitored by histopathologic analysis and 20-MHz ultrasound.

Results

A total of 27 patients were treated with LD UVA1 (20 J/cm2), 18 patients received MD UVA1 (50 J/cm2), and 19 patients were treated with NB UVB dependent on their skin type. Phototherapy was performed 5 times weekly for 8 weeks. Two of the 64 patients included in this trial discontinued therapy. Skin status significantly improved in all patients who finished the treatment protocol, resulting in a reduction of the clinical score in all groups (LD UVA1, 7.6-5.0 [P < .001, 95% confidence interval 1.6-3.4]; MD UVA1, 11.1-6.6 [P < .001, 95% confidence interval 2.5-6.2]; NB UVB, 7.3-4.9 [P < .001, 95% confidence interval 1.6-3.2]). The reduction of the score was accompanied by an improvement of the visual analog scale for itching and tightness, histologic score, and 20-MHz ultrasound. MD UVA1 was significantly more effective than NB UVB (P < .05). There were no significant differences between LD UVA1 and NB UVB and the former and MD UVA1 (P > .05).

Limitations

We had a relatively small study sample and nonblinded assessment of primary outcome.

Conclusion

Phototherapy, as previously reported in several noncontrolled trials, is an effective therapeutic option in LS, with a favorable risk/benefit ratio. UVA1 phototherapy should be considered among the first approaches in the management of LS.

Section snippets

Patients

This was a prospective randomized 3-arm comparison study including active controls. The setting was a university hospital. From 2004 to 2005, 64 consecutive patients with LS were included in the study after giving informed consent. All patients were recruited from dermatologic outpatient clinics. The study protocol was approved by the ethics review board. All included patients were white and had skin type II or III. For each patient, a complete disease history was obtained before starting

Results

In all, 64 patients were included in this trial, 27 in the LD UVA arm, 18 in the MD UVA arm, and 19 in the NB UVB arm. Patient mean age in the 3 subgroups was 36.2, 43.7, and 47.7 years, and mean duration of disease was 4.4, 4.9, and 7.9 years, respectively. Baseline demographics and disease characteristics were similar for the 3 treatment groups and are summarized in Table I. Two patients discontinued phototherapy before finishing the treatment protocol because of reasons independent to the

Discussion

UV therapy has once more demonstrated its high value in the poor therapeutic armamentarium of sclerotic skin diseases. The introduction of psoralen and UVA in 1994 was recognized as a cornerstone in the management of LS.2 However, disadvantages of psoralen and UVA such as possible gastrointestinal and carcinogenic effects have led to an intense search for alternatives. In this context, UVA1 can be considered as the most recent advance in phototherapy for LS. Three main pathways are considered

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    Funding sources: None.

    Conflicts of interest: None identified.

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    Copyright © 2006 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.