Sator 2009.

Methods	This was a prospective, randomised, within‐patient, 3‐arm comparison trial conducted in Austria. The aim of this study was to evaluate the relative efficacy of low‐ versus medium‐dose UVA‐1 phototherapy for plaque‐type morphea, with a control plaque that remained unirradiated. The study extended during a follow‐up period of 1 year after treatment to assess the duration of the therapeutic response.
Participants	Inclusion criteria: presence of active plaque‐type morphea with at least 3 lesions of comparable localization and evolution. Exclusion criteria: other types of morphea or systemic scleroderma, pregnancy or lactation, age younger than 14 years, severe cardiac insufficiency, systemic or local corticosteroids or any other disease‐related therapies within 4 weeks before study entry, abnormal photosensitivity, or intake of photosensitising drugs. Number of participants: 16 Number of lesions randomised: 48 (16 group 1 + 16 group 2 + 16 group 3) Number of lesions analysed: 42 (14 group 1 + 14 group 2 + 14 group 3) Women: 10 Men: 4 Age: 15 to 69 years old (median 49 years) Ethnicity: Caucasian, 3 participants had skin type II and 11 participants had skin type III. Morphea type: plaque Length of illness: between 4 months and 10 years (median 30 months). Participant's prior treatments: all participants had been unresponsive to previous treatment with topical corticosteroids.
Interventions	Lesion 1: a. Therapy and dosage: the participant's whole body (including a selected target plaque) was treated with medium‐dose UVA‐1 (70 J/cm²), 4 times a week for 5 weeks and 2 times a week for another 5 weeks (30 UVA‐1 exposures totalising 2100 J/cm²). b. Administration: topical c. Duration of treatment: 10 weeks d. Follow‐up after treatment: 12 months Lesion 2: a. Therapy and dosage: a second plaque only received 20 J/cm² (low‐dose UVA‐1), 4 times a week for 5 weeks and 2 times a week for another 5 weeks (30 UVA‐1 exposures totalising 600 J/cm²). b. Administration: topical c. Duration of treatment: 10 weeks d. Follow‐up after treatment: 12 months Lesion 3: a. Therapy and dosage: a third plaque was always shielded from irradiation (unirradiated control). b. Administration: topical c. Duration of treatment: 10 weeks d. Follow‐up after treatment: 12 months Additional therapy for all lesions was restricted to the use of emollients that were applied once every evening.
Outcomes	Primary outcome: mean decrease in skin thickness at the end of the treatment as assessed by high‐frequency ultrasound. Secondary outcomes: mean decrease in skin thickness during the follow‐up period and the mean decrease in the clinical scleroderma score. Authors used a numeric scleroderma scoring systema according to a modified score of Hulshof and colleagues and Rodnan and colleagues. For each plaque, a sum score for the intensity of erythema and induration were each assessed on a 4‐point ordinal scale between 0 (absent) and 3 (maximum intensity). Atrophy was assessed as 0 (absent) or 1 (present). Assessments: the participants were examined by the same investigator at baseline, at the end of phototherapy, and 3, 6 and 12 months after treatment. The mean value of 3 ultrasound measurements was taken. All side effects of treatment were recorded during the study
Notes	Intervention product information/details: 24‐kW dermalight ultrA1 unit (Dr Sellmeier, Gevelsberg, Germany) with an emission spectrum between 340 and 440 nm. The irradiance at skin level was measured with a double monochromator (Bentham DM 150, Bentham Instruments Ltd, Reading, Berkshire, UK) and ranged between 70 and 75 mW/cm². Outcome measurement product information/details: high‐frequency ultrasound system (Dermascan C, Cortex Technology, Hadsund, Denmark) with a long‐focusing transducer. The probe had a frequency of 20 MHz. The total thickness of epidermis and dermis was measured. The gain compensation curve was adjusted in the oblique position at 20 to 45 dB. Trial registration: authors did not mention a registered protocol. Ethics committee approval: Medical University of Vienna. Funding sources: authors declared no funding. Declarations of interest: authors declared no conflicts of interested.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Allocation to treatment with 70 J/cm², 20 J/cm², or no irradiation was done by using a computer‐generated randomisation list". Comment: The method used to generate the random sequence was adequate to produce comparable groups.
Allocation concealment (selection bias)	Unclear risk	Authors did not provide enough information to judge if the intervention allocation could be foreseen before or during the recruitment of participants.
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Quote: "Each time, the patient’s whole body (including a selected target plaque) was treated with medium‐dose UVA1 (70 J/cm²) with the exception of a second plaque that only received 20 J/cm² (low‐dose UVA1) and a third plaque that was always shielded from irradiation to rule out spontaneous remission (unirradiated control)." Comment: each participant had 1 lesion treated differently from the whole body, and 1 untreated lesion. Thus, participants and personnel had knowledge of the treatment. The outcome is likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "The patients were always examined by the same unblinded investigator. A blinded assessment was not performed because UVA1‐induced pigmentation in the periphery of the target lesions would have immediately allowed the investigator to distinguish between irradiated and control plaques". Comment: The outcome assessor was unblinded from knowledge of which intervention a participant received. The outcome is likely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "Two patients were withdrawn from evaluation because of irregular attendance to treatment". Comment: authors excluded these 2 participants from the statistical evaluation, performing 'as treated' analysis. ITT analysis includes data from all randomised participants, regardless of study completion.
Selective reporting (reporting bias)	High risk	Authors reported only median or mean value (without standard deviation) for outcomes results.
Other bias	Unclear risk	The clinical tool used assessed individual lesions instead of all the lesions of the individual, which could affect the result