Skip to main content
. 2020 Mar 16;2020(3):CD011154. doi: 10.1002/14651858.CD011154.pub2

Papageorgiou 2000.

Methods Study design: parallel design
Duration of follow‐up: 8 weeks
Participants Total number of participants randomised: N = 45
Inclusion criteria: grade I acne severity and ≥ 5 inflammatory lesions
Exclusion criteria
  • Severe nodulo‐cystic acne requiring oral treatment

  • Using any acne therapy, systemic or topical, for 2 weeks before study entry, using any antibiotics and oestrogens during the study

  • Pregnancy


Sites of acne: face
Severity of acne and corresponding criteria of judgement: unclear
Treatment before study: unclear
Participants' baseline data presented as mean (SD) for each group
Sex ratio (male/female): A = 4/9; B = 3/10; C = 4/11
Age (years): A = 29.5 (range 19 to 50); B = 26.2 (range 14 to 43); C = 27.5 (range 14 to 50)
Duration of acne (year): unclear
Interventions Interventions in Group A
  • Topical treatment: chloroxylenol/zinc oxide

  • Regimen: leave‐on

  • Concentration: unclear

  • Vehicle: cream

  • Dose: twice daily

  • Duration: 8 weeks

  • Number of participants assigned: unclear


Interventions in Group B
  • Topical treatment: BPO

  • Regimen: leave‐on

  • Concentration: 5%

  • Vehicle: cream

  • Dose: twice daily

  • Duration: 8 weeks

  • Number of participants assigned: unclear


Interventions in Group C
  • Topical treatment: placebo

  • Regimen: leave‐on

  • Concentration: N/A

  • Vehicle: cream

  • Dose: twice daily

  • Duration: 8 weeks

  • Number of participants assigned: unclear


Co‐interventions: none
Outcomes Primary outcomes of review interest
  • Participant global self‐assessment of acne improvement (assessed as worse, no change (0 to 9%), mild improvement (10% to 39%), moderate improvement (40% to 69%), marked improvement (70% to 89%), and clearance (> 90%))

  • Withdrawal due to adverse effects, including worsening of acne


Secondary outcomes of review interest
  • Investigator‐assessed change in lesion counts

  • Percentage of participants experiencing any adverse event


Other outcomes reported in the study
  • Investigator graded overall improvement on a scale (assessed as worse, no change (0 to 9%), mild improvement (10% to 39%), moderate improvement (40% to 69%), marked improvement (70% to 89%), and clearance (> 90%))*


Participants were evaluated at baseline and at 4 and 8 weeks of treatment
*This outcome was assessed as the primary outcome in the trial
Study details Study period: unclear
Country: unclear
Setting: unclear
Number of study centres: multiple but unclear
Washout period: 2 weeks washout for any systemic or topical acne therapy
Registered number: unclear
ITT analysis: no
Publication details Language of publication: English
Funding: unclear
Conflicts of interest: not specified
Publication status: full article
Stated aim for study Quote from publication: "the purpose of this trial was to evaluate this new product and compare its efficacy and safety with a more traditional acne therapy, 5% benzoyl peroxide cream"
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: no information on the method used to generate the random sequence was provided
Allocation concealment (selection bias) Unclear risk Comment: insufficient information about allocation concealment was provided
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "this trial was a double‐blind controlled randomized parallel group comparison..."
Comment: who was blinded remains unclear. However, complete blinding was difficult as treatment‐related adverse events were more common in the BPO group
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "this trial was a double‐blind controlled randomized parallel group comparison..."
Comment: who was blinded remains unclear. However, complete blinding was difficult as treatment‐related adverse events were more common in the BPO group
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Quote: "four patients either voluntarily left the study or were lost to follow‐up"
Comment: numbers of and reasons for withdrawal for each group were unclear
Selective reporting (reporting bias) Unclear risk Comment: although all outcomes listed in the methods section were reported, we could not identify the corresponding protocol nor relevant information on a trial registry to confirm that selective reporting was avoided
Other bias High risk Quote: "the three groups were well matched in terms of number of patients, age, sex distribution and severity of acne (Table 1)"
Comment: baseline characteristics were similar between groups. The washout period for systemic acne treatments was not long enough