Clindoxyl® Gel (Clindamycin Phosphate and Benzoyl Peroxide) Overview

Introduction

• Agents such as benzoyl peroxide, clindamycin and erythromycin have been the mainstay of topical acne therapy
• Consideration in the development and selection of newer topical anti-acne combinations include
  • Efficacy
  • Compliance
  • Reducing the risk of antibiotic resistance.

There are limitations for regulators, pharmaceutical companies and pharmaceutical sales representatives to present clinical evidence following development of product monograph and drug approval. The product monograph is the starting point for this A-Detail™. It also contains evidence-based decision making processes, current standards of practice and clinical experience to provide a practical approach to the treatment of this condition.

Disclaimer: This A-Detail™ is meant to be a practical guide and does not necessarily reflect all risks, side-effects or situations associated with this product.

Clinical Experience

• Clinical experience confirms what has been shown in clinical trials, that Clindoxyl Gel is effective and well tolerated
• Once daily application of topical that combines two active anti-acne agents may well increase patient compliance
• Clindoxyl Gel can be used once in the evening and a topical retinoid at an alternate time of day, if necessary

Mechanisms of action

• Benzoyl peroxide – produces free-radical oxygen that oxidizes bacterial proteins and has a mild keratolytic effect on comedones
• Clindamycin – inhibits bacterial protein synthesis by binding to 50S ribosomal units. It is bacteriostatic at low concentrations and bactericidal at higher concentrations.

Bacterial resistance

• Antibiotic resistance to the follicular bacteria P. acnes has been increasing over the years of antibiotic use
• Antibiotic resistant P. acnes increased from 34% in 1991 to 60% in 1996 in an acne outpatient clinic in Leeds in England
• Resistance was most commonly seen to erythromycin. This suggests that erythromycin might be less suited for long term use.
• Adding benzoyl peroxide to a topical antibiotic appears to reduce the ability of the bacteria to become resistant.

Indications

• Moderate comedonal and papulo-pustular acne
• Approved in Canada as a once daily topical for moderate Acne in December 2000
• Off-label uses include
  • Papulo-pustular Rosacea
  • Folliculitis

Patient Profile

• Any patient who has inflammatory acne can be treated with Clindoxyl Gel
• Acne patients with comedones only are best treated by topical retinoids
• Patients with cystic acne usually require systemic therapy. For those more severe patients not on oral Isotretinoin, topical therapy in combination with the oral medication is recommended.

Contraindication

• Hypersensitivity to benzoyl peroxide, clindamycin, lincomycin or any of the excipients

Relative contraindications

• Inflammatory bowel disease
• Antibiotic associated colitis

Dosing

• Once daily application of Clindoxyl Gel is recommended
• The product needs to be applied to the whole region of skin that is affected with acne. In other words ‘spot treatment’ is not the best way of using this or any other anti-acne product.

Efficacy

The following figures show pooled data from randomized, controlled double-blind trials involving 673 patients with acne:

Reduction in non-inflammatory acne lesions after 11 weeks

Reduction in inflammatory acne lesions after 11 weeks

Percentage of patients in the clinical trials with good to excellent improvement

REFERENCES:

[ Lookingbill DP et al. J Am Acad Derm 37(4):590-5(1997 Oct)]

Treatment of acne with a combination of clindamycin/benzoyl peroxide gel compared with clindamycin gel, benzoyl peroxide gel, and vehicle gel: combined results of two double blind investigations.

[Tan J.K.L. Clindoxyl Gel for the Treatment of Acne Vulgaris:]
Skin Therapy Letter Vol 7 No.5 May 2002

Compliance

• Three factors to consider for good compliance of Clindoxyl Gel are:
  • Well tolerated by most patients
  • Results are often seen within 2 weeks
  • Reasonably priced

Side Effects, Safety and Risks

• Overall tolerance was rated as excellent in 94% of patients
• Potential side effects expected in some patients
  • Pruritus, erythema, dryness and worsening of acne
• Suggestions for minimizing side effects in practice are as follows:
  • For those with sensitive skin, apply less product
  • Using Clindoxyl Gel on unwashed skin reduces irritation
  • Washing off the product after a few minutes for the first few days can reduce irritation, as can applying only on alternate days until tolerated

Cost of Treatment

• This is a cost effective product
• Reducing inflammation can reduce the risks of scarring