BACKGROUND:Benzoyl peroxide (BP) is a first-line topical treatment in acne vulgaris (AV). However, its use can cause mild skin irritation and dryness. A new formulation of hydrogen peroxide stabilised (HPS) in monoglycerides cream (Crystacide 1%), indicated in the topical treatment of superficial skin infections, is now available as an alternative treatment. STUDY AIM: To evaluate efficacy and local tolerability of HPS in mild-to-moderate AV in comparison with BP gel. METHODS AND PATIENTS: In a randomised, prospective, investigator-masked parallel-group, 8-week trial, 60 patients (24 men, 36 women, mean age 25 +/- 6 years) with mild-to-moderate AV, affecting mainly the face, were enrolled in the study, after their informed consent. HPS or BP (PanOxyl gel 4%) was applied topically twice daily for 8 weeks. STUDY OUTCOMES: The study endpoints were: (1) Reduction in mean inflammatory (IL), noninflammatory (NIL) and total (TL) acneic lesions in comparison with baseline; (2) Local tolerability assessed evaluating erythema, dryness and burning sensation, using a 0-3 qualitative score (score 0 = poor tolerability; score 3 = very good tolerability). RESULTS:TL, NIL, and IL were assessed by an investigator unaware of treatment allocation at baseline, and week 8. The tolerability score (TS) was assessed at week 4 and 8. At baseline, the two groups were well matched for the main clinical and demographic characteristics. All patients concluded the trial. At week 0, in the HPS group TL, NIL and IL (mean +/- SD) were: 35 +/- 8, 20 +/- 6 and 16 +/- 7. At week 8, HPS reduced TL to 16 +/- 7; NIL to 9 +/- 3 and IL to 7 +/- 3 (p < 0.001). At baseline, TL, NIL and IL, in the BP group, were 32 +/- 9, 24 +/- 8 and 18 +/- 7, respectively. At week 8, BP reduced TL, NIL and IL to 14 +/- 9; 7 +/- 5 and 7 +/- 3 (p < 0.001). In comparison with baseline values, the percentage reductions of IL were 58% and 61% for HPS and BP,respectively (p = n.s.). At the end of the study the TS was 2.9 +/- 0.2 in HPS group and 2.4 +/- 0.8 in BP group (p < 0.025). Two patients in HPS group (6%) and seven patients (23%) in BP group suffered from mild-to-moderate local erythema. CONCLUSIONS:HPS has shown to be as effective as BP in reducing both inflammatory and noninflammatory AV lesions in patients with mild-to-moderate disease. In comparison with BP 4% gel, HPS cream shows a better local tolerability profile.
RCT Entities:
BACKGROUND:Benzoyl peroxide (BP) is a first-line topical treatment in acne vulgaris (AV). However, its use can cause mild skin irritation and dryness. A new formulation of hydrogen peroxide stabilised (HPS) in monoglycerides cream (Crystacide 1%), indicated in the topical treatment of superficial skin infections, is now available as an alternative treatment. STUDY AIM: To evaluate efficacy and local tolerability of HPS in mild-to-moderate AV in comparison with BP gel. METHODS AND PATIENTS: In a randomised, prospective, investigator-masked parallel-group, 8-week trial, 60 patients (24 men, 36 women, mean age 25 +/- 6 years) with mild-to-moderate AV, affecting mainly the face, were enrolled in the study, after their informed consent. HPS or BP (PanOxyl gel 4%) was applied topically twice daily for 8 weeks. STUDY OUTCOMES: The study endpoints were: (1) Reduction in mean inflammatory (IL), noninflammatory (NIL) and total (TL) acneic lesions in comparison with baseline; (2) Local tolerability assessed evaluating erythema, dryness and burning sensation, using a 0-3 qualitative score (score 0 = poor tolerability; score 3 = very good tolerability). RESULTS: TL, NIL, and IL were assessed by an investigator unaware of treatment allocation at baseline, and week 8. The tolerability score (TS) was assessed at week 4 and 8. At baseline, the two groups were well matched for the main clinical and demographic characteristics. All patients concluded the trial. At week 0, in the HPS group TL, NIL and IL (mean +/- SD) were: 35 +/- 8, 20 +/- 6 and 16 +/- 7. At week 8, HPS reduced TL to 16 +/- 7; NIL to 9 +/- 3 and IL to 7 +/- 3 (p < 0.001). At baseline, TL, NIL and IL, in the BP group, were 32 +/- 9, 24 +/- 8 and 18 +/- 7, respectively. At week 8, BP reduced TL, NIL and IL to 14 +/- 9; 7 +/- 5 and 7 +/- 3 (p < 0.001). In comparison with baseline values, the percentage reductions of IL were 58% and 61% for HPS and BP,respectively (p = n.s.). At the end of the study the TS was 2.9 +/- 0.2 in HPS group and 2.4 +/- 0.8 in BP group (p < 0.025). Two patients in HPS group (6%) and seven patients (23%) in BP group suffered from mild-to-moderate local erythema. CONCLUSIONS:HPS has shown to be as effective as BP in reducing both inflammatory and noninflammatory AV lesions in patients with mild-to-moderate disease. In comparison with BP 4% gel, HPS cream shows a better local tolerability profile.
Authors: Tamás Tóth; Hans Broström; Viveca Båverud; Ulf Emanuelson; Elisabeth Bagge; Tommy Karlsson; Kerstin Bergvall Journal: Acta Vet Scand Date: 2011-06-30 Impact factor: 1.695