El‐Mofty 2004.

Methods	This was a prospective, randomised, 3‐arm active comparison trial, conducted in Egypt. The aim of this study was to define the lowest effective broadband UVA dose in the treatment of morphea and SSc.
Participants	Inclusion criteria: individuals complaining of cutaneous sclerosis. Exclusion criteria: authors did not report this information. Number of participants randomised: 67 participants with morphea. This study also included 17 individuals with systemic scleroderma (their abbreviation = SS), who were randomised separately from the morphea group. Number of participants analysed: 63 participants with morphea (16 group 1 + 21 group 2 + 26 group 3) Women: 43 (6 group 1 + 16 group 2 + 21 group 3) Men: 20 (10 group 1 + 5 group 2 + 5 group 3) Age: mean age in group 1 was 17.88 ± 13.00 years (3 to 47), 22.14 ± 12.90 years (6 to 51) in group 2 and 20.85 ± 14.75 years (6 to 66) in group 3. Ethnicity: 9 participants were skin type III, 37 participants were skin type IV and 17 participants were skin type V, according to Fitzpatrick’s classification. Morphea Type: 27 participants presented with circumscribed morphea (7 group 1 + 12 group 2 + 8 group 3), 12 participants presented with linear scleroderma (3 group 1 + 1 group 2 + 8 group 3) and 24 participants presented with generalised morphea (6 group 1 + 8 group 2 + 10 group 3). Length of illness: between 1 and 10 years; 20.28 ± 22.69 months (2 to 8) in group 1, 25.48 ± 33.12 months (1 to 120) in group 2 and 23.54 ± 24.46 months (1 to 120) in group 3.
Interventions	Total body irradiation with different low doses of UVA (320 nm to 400 nm; broadband light source with a spectrum of 315 nm to 400 nm and a maximum at 365 nm). During therapy patients wore protective goggles and covered the genitals. Group 1: a. Therapy and dosage: 5 J/cm²/session, 3 times a week for 20 sessions. b. Administration: topical c. Duration of treatment: 7 weeks d. Follow‐up after treatment: none Group 2: a. Therapy and dosage: 10 J/cm²/session, 3 times a week for 20 sessions. b. Administration: topical c. Duration of treatment: 7 weeks d. Follow‐up after treatment: none Group 3: a. Therapy and dosage: 20 J/cm²/session, 3 times a week for 20 sessions. b. Administration: topical c. Duration of treatment: 7 weeks d. Follow‐up after treatment: none
Outcomes	Inspection of the skin lesions as regards site, colour (hypo‐ or hyperpigmented), pattern of lesions (circumscribed, linear or disseminated) and palpation of the lesions for skin thickening, induration, atrophy and sclerosis were performed. The clinical response was assessed subjectively by palpation of the skin lesions for skin softening, graded as very good response (marked skin softening, almost normal skin texture), good response (moderate softening), fair response (mild softening) and poor response (no change in skin texture). Investigators assessed clinically other associated manifestations such as trophic changes, grip strength, flexion deformity, joint mobility, by evaluating each point as present (+) or absent (−) before treatment. After treatment, the criteria with (+) or present, were evaluated for an improvement, without scaling for the degree of change, and recorded as such. Participants and physicians also assessed subjectively these other manifestations. Pre‐ and post‐treatment skin specimens were obtained from some morphea participants (4 from group I; 5 from group II; and 7 from group III) from the same plaque, and stained (haematoxylin and eosin) for routine histopathologic examination. Assessments: before starting UVA therapy, every week and at the end of the study period (20 sessions).
Notes	Intervention product information/details: source of UVA was a Waldmann Medizin technik UVA cabin 7001 equipped with 40 UVA lamps and PUVA 1000 cabin containing 26 lamps of Waldmann type F 85/100 W‐PUVA. Trial registration: authors did not register a protocol for this study. Ethics committee approval: a research ethics committee was not established at Cairo University. Funding source: authors declared no funding sources. Declarations of interest: authors declared no conflict of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Patients were randomly divided into three groups". Comment: authors did not describe the method used to generate the random sequence in sufficient detail to allow an assessment of whether the allocation was adequate to produce comparable groups. However, authors responded to our contact and informed that they generated the random sequence by shuffling envelopes. Thus the process was adequate to produce comparable groups.
Allocation concealment (selection bias)	Low risk	Authors did not provide enough information to judge if the intervention allocation could be foreseen before or during the recruitment of participants. However, authors responded to our contact and informed that the allocation was unsealed only on the admission to the first treatment session.
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Authors did not describe blinding, but responded to our contact and confirmed there was no blinding to the knowledge of which intervention a participant received. Thus the outcome is likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Authors did not clearly describe whether the outcome assessors were effectively blinded from knowledge of which UVA dose each participant received. However, authors responded to our contact and informed that the outcome assessors were unblinded to the knowledge of which intervention a participant received; only the histopathological assessors were blinded. Thus, the outcome measurement of interest is likely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "Of 67 M patients who started UVA therapy, 63 completed the study. Dropouts were not related to therapy". (M = circumscribed morphea) Quote: "Clinical data of the 63 patients were assessed". Comment: authors excluded 4 patients (without informing from which group they were) and performed 'as treated' analysis, including data only from the participants who completed the treatment. However, this probably does not represent serious threats to validity of the results.
Selective reporting (reporting bias)	Unclear risk	The study protocol is not available.
Other bias	Unclear risk	The clinical assessment was not a validated measure, which could affect the result.