BACKGROUND: Treatments currently used in acrosclerosis for patients with systemic sclerosis (SS) are not very efficient and are associated with adverse effects. Several reports concern the efficacy of ultraviolet A1 (UVA1) phototherapy for localized scleroderma. Recent studies appear to indicate the interest of UVA1 in acrosclerosis for patients with SS. However, these studies are uncontrolled. OBJECTIVE: To determine whether UVA1 phototherapy is effective for acrosclerosis in SS with a randomized, investigator-blinded, controlled study. METHODS:Nine patients with SS completed the study. The duration of disease ranged from 6 to 21 years. None of them had received glucocorticoids or immunosuppressive agents. Low-dose UVA1 phototherapy (40 J/cm(2)) of the randomized hand was performed three times weekly over a period of 14 weeks. The other hand served as control. The clinical evaluation used a modified semiquantitative skin scoring system, the index flexion and extension, and a visual analog scale (VAS) was performed at baseline and after treatment. RESULTS: The mean of skin score and VAS improved significantly (P<0.05), but this improvement does not appear to be different between the treated or the untreated hands. There was no modification of the index flexion or extension. Two patients noticeably improved the functions of the treated hand. No side effects were observed. CONCLUSIONS: These results suggest that UVA1 phototherapy does not improve cutaneous thickness in acrosclerosis even if few functional improvements, and some ulcerations healings can be occasionally observed. However, a larger scale trial is necessary to confirm this inefficiency.
RCT Entities:
BACKGROUND: Treatments currently used in acrosclerosis for patients with systemic sclerosis (SS) are not very efficient and are associated with adverse effects. Several reports concern the efficacy of ultraviolet A1 (UVA1) phototherapy for localized scleroderma. Recent studies appear to indicate the interest of UVA1 in acrosclerosis for patients with SS. However, these studies are uncontrolled. OBJECTIVE: To determine whether UVA1 phototherapy is effective for acrosclerosis in SS with a randomized, investigator-blinded, controlled study. METHODS: Nine patients with SS completed the study. The duration of disease ranged from 6 to 21 years. None of them had received glucocorticoids or immunosuppressive agents. Low-dose UVA1 phototherapy (40 J/cm(2)) of the randomized hand was performed three times weekly over a period of 14 weeks. The other hand served as control. The clinical evaluation used a modified semiquantitative skin scoring system, the index flexion and extension, and a visual analog scale (VAS) was performed at baseline and after treatment. RESULTS: The mean of skin score and VAS improved significantly (P<0.05), but this improvement does not appear to be different between the treated or the untreated hands. There was no modification of the index flexion or extension. Two patients noticeably improved the functions of the treated hand. No side effects were observed. CONCLUSIONS: These results suggest that UVA1 phototherapy does not improve cutaneous thickness in acrosclerosis even if few functional improvements, and some ulcerations healings can be occasionally observed. However, a larger scale trial is necessary to confirm this inefficiency.