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. 2012 Aug 15;2012(8):CD002086. doi: 10.1002/14651858.CD002086.pub2

Sheehan‐Dare 1989.

Methods
  • This was a double‐blind, double‐dummy RCT in a hospital setting.

  • The duration of the trial was 12 weeks.

  • Randomisation was stated to be by matched pairs on the basis of age, sex, acne grade, and numbers of both inflamed and non‐inflamed lesions, but no details were given about the method of sequence generation.

  • Industrial support came from Upjohn.

  • UV control was used in the winter months.

  • Previous acne treatment was stopped 30 days before the start of the trial, which included all acne therapy, antibiotics, corticosteroids, and antiandrogens.

  • Evaluation was at 0, 4, 8, and 12 weeks.

  • The area evaluated was the face.

  • The assessor was not stated.

  • All participants who completed the trial according to the protocol were included in the analysis. The following statistical tests were used: student's t‐test for differences from baseline, and the second trial publication also reported that analysis of variance and Newman‐Keuls techniques were used, and an analysis of variance for between group differences was undertaken.

Participants 66 participants were enrolled.
 33 participants were randomised to the minocycline group; 33 participants were randomised to the clindamycin group.
 There was 1 (6%) dropout in the minocycline group and 6 (18%) in the clindamycin group.
 The age range was 14 to 35.
 Recruitment was fulfilled by hospital out‐patients.
There was baseline comparability (age, sex, grade, and count).
Inclusion criteria of the trial
  • Moderate to severe facial acne, 10 to 120 IL with a maximum of 6 NOD/cyst on the face


Exclusion criteria of the trial
  • PREG, BF, SENS, started or stopped OC within 90 days of the study, history of chronic bowel disease or diarrhoea

Interventions
  • Minocycline 50 mg bd

  • Clindamycin phosphate 1% topical solution bd


Appearance: standard but double‐dummy used
 Concomitant therapy: not specified
 Instructions: capsules to be taken before meals, apply lotion to whole face
 Skin hygiene: not specified
 Empty stomach: not specified
 Compliance: not specified
Outcomes Outcomes of the trial
  1. NIL (Cc, Co) and IL count (PA, PU, NOD, MAC)

  2. Grade: Leeds (0 to 10) (Burke 1984)

  3. Mean changes in NILC and ILC, and grade from baseline (primary outcome)

  4. Adverse drug reactions as reported by the participants

Notes Country: United Kingdom
 Language: English
Review version: 2002
 Data were presented in graphical form only.
 Macules were included in the ILC.
 Grades and counts were log transformed prior to analysis.
 The manufacturers or authors couldn't supply further information.
The numbers of participants in each group were not reported.
There were differences between the 2 reports of the same trial, including whether or not there was a statistically significant reduction in non‐inflamed lesion counts, and in the type of statistical tests used.
There were differences between 2 publications of this trial.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation was stated to be by matched pairs on the basis of age, sex, acne grade, and numbers of both inflamed and non‐inflamed lesions, but no details were given about the method of sequence generation.
Allocation concealment (selection bias) Unclear risk This was unclear; no details were given.
Blinding (performance bias and detection bias) 
 All outcomes Low risk It was stated to be "double blind, double dummy" (page 25 of the published report). No further details were given.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 66 participants were enrolled, but there were no details on how many participants were randomised to each group: It was assumed to be 33 due to matched pairs. 6 dropped out from the clindamycin arm and 1 from the minocycline arm, but it was unclear at which time point these dropouts occurred.
Selective reporting (reporting bias) Low risk All outcomes, including adverse events, were reported at each time point. No data were reported (graphical only).