Pelfini 1989.

Methods	This was an open‐label RCT in 3 centres. The duration of the trial was 8 weeks. The method of randomisation was not stated. Industrial support came from Schering. There was no information regarding the use of UV control. No details were provided regarding oral and topical treatment withdrawal. Evaluation was at 0, 2, 4, 6, and 8 weeks. The area evaluated was 1 side of the face (Plewig and Kligman (P&K) scale). There were no details of the assessor. A per‐protocol analysis was used.
Participants	122 participants were enrolled. 61 participants were randomised in the minocycline group, and 61 participants were randomised in the josamycin group. There was 1 dropout (minocycline participant). The mean age was 21.3 in the minocycline group (range = 14 to 34) and 20.3 in the josamycin group (range = 14 to 33). Participants were recruited from the university dermatology departments. Inclusion criteria of the trial severe or refractory papulopustular acne Exclusion criteria of the trial No details
Interventions	For micropapulopustular variant IIa: minocycline 100 mg orally once‐daily for 2 months (n = 39) For micropapulopustular variant Ia: josamycin 500 mg once‐daily for 2 months (n = 39) For micropapulopustular variant IIb: minocycline 200 mg orally once‐daily for 2 months (n = 22) For micropapulopustular variant Ib: josamycin 1000 mg once‐daily for 2 months (n = 22) Concomitant therapy: "In 69 patients, 35 in the josamycin group, 34 in the minocycline group, the clinical presentation suggested the association of a topical medication 5% benzoyl peroxide ointment to the oral treatment." Appearance: standard Instructions: orally once‐daily for 2 months Skin hygiene: no details Empty stomach: no details Compliance: no details
Outcomes	Outcomes of the trial Grade: Plewig and Kligman grades I to IV based on lesion counts, pustules, nodulo‐cysts erythema, and seborrhoea Reduction in number and severity of lesions (primary outcome) Adverse drug reactions
Notes	Country: Italy Language: English Review version: 2012 35/61 josamycin participants and 34/61 minocycline participants suggested concomitant use of 5% benzoyl peroxide treatment at presentation. There was concomitant use of benzoyl peroxide in some participants. There were 2 different regimens, and it was unclear how participants were allocated to each. This was a very poor trial write‐up due to the English not being the first language of the authors.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quote: "...randomly allocated." Comment: The report suggests that a number of participants were also given 5% benzoyl peroxide, which is very active. These were not randomised. Also, there were 2 different treatments schedules, and it was unclear how they were randomised (possibly based on severity).
Allocation concealment (selection bias)	Unclear risk	This was unclear; no details were given.
Blinding (performance bias and detection bias) All outcomes	High risk	'Previous open studies...' was stated, implying that this was also open.
Incomplete outcome data (attrition bias) All outcomes	Low risk	1/61 participants discontinued in the minocycline group due to severe gastric intolerance. It appears all other participants provided data.
Selective reporting (reporting bias)	Low risk	All prespecified outcomes were reported. The results were presented graphically only.