Efficacy and Safety of Stabilised Hydrogen Peroxide Cream (Crystacide) in Mild-to-Moderate Acne Vulgaris: A Randomised, Controlled Trial Versus Benzoyl Peroxide Gel

Massimo Milani, Andrea Bigardi, Marco Zavattarelli

Disclosures

Curr Med Res Opin. 2003;19(2) 

In This Article

Summary and Introduction

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), non-inflammatory (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 non-inflammatory AV lesions in patients with mild-to-moderate disease. In comparison with BP 4% gel, HPS cream shows a better local tolerability profile.

Acne vulgaris (AV) is a very common disease affecting 80-85% of teenagers and young adults.[1] The pathology of AV is a complex phenomenon, involving abnormal keratinisation, hormonal functions, immune hypersensitivity and bacterial growth.[2] The disease is limited to pilosebaceous follicles of the head and upper trunk. Propionibacterium acnes (P. acnes) is an obligate anaerobic microorganism which plays a pivotal role in the physiopathology of inflammatory AV.[3] Mild papulopustular acne is generally responsive to topical treatment. Oxidative agents, such as benzoyl peroxide (BP), share a potent bactericidal activity against P. acnes.[4] Topical BP is very effective in the treatment of mild-to-moderate papulopustural AV. As such BP, 2.5-10%, is considered a first-line topical treatment in acne vulgaris (AV).[5] However, its use can cause skin irritation or dryness.[6] Benzoyl peroxide rapidly decomposes into benzoic acid and hydrogen peroxide and it is known that benzoic acid can be responsible for skin irritation and erythema. A new formulation of hydrogen peroxide (H2O2) stabilised in monoglycerides cream (HPS) (Crystacide* 1%), indicated in the topical treatment of superficial skin infections, is now available.[7] This formulation has been shown to be clinically active and well tolerated in the treatment of impetigo. Until now, no clinical data have been available regarding the efficacy and safety profile of this oxidative compound in the treatment of acne.

The primary study aims of this multicentre, randomised, investigator-masked trial were to evaluate efficacy and local tolerability of HPS in mild-to-moderate AV patients, in comparison with BP gel.

*Crystacide is a registered trade name of Mipharm, Italy
†PanOxyl is a registered trade name of Stiefel Laboratories Inc, Coral Gables, Fl, USA

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