PR-00908.1 Evaluation of Novel Topical Antibiotic in Acne Patients

• Research type

  Research Study

• Full title

  A PLACEBO CONTROLLED, SINGLE BLIND, PILOT CLINICAL EVALUATION OF THE EFFECT OF A NOVEL ANTIBIOTIC PREPARATION ON THE CUTANEOUS MICROFLORA AND CLINICAL SIGNS IN ACNE PATIENTS.

• IRAS ID

  11441

• Contact name

  David Chesters

• Sponsor organisation

  Warner Chilcott Company, Inc.

• Eudract number

  2008-002642-32

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This pilot study will evaluate the efficacy of a new topical preparation of minocycline (study drug) in the treatment of mild to moderate acne vulgaris (commonly termed acne), with particular reference to its effects on bacteria found on the skin known to be associated with acne. Minocycline is a member of the tetracycline class of antibiotics. It has a long history of safe use and exhibits broad-spectrum activity against a wide variety of microorganisms. The efficacy of two concentrations of minocycline (2.0% and 0.5% ) will be compared to placebo. Acne affects up to 85% of the population at some point in their life. It is a distressing condition with a negative social impact on the sufferer. Antibiotics are routinely used to treat acne; initially as topical preparations then as systemic drugs should the topical treatment prove less effective than desired. Tetracycline antibiotics have a number of known side effects, more usually associated with the oral administration of the drugs (systemic) and not when they are applied to the skin as a cream or a gel (topical application). Thus, the development and optimisation of an effective topical system for minocycline is desirable to improve treatment for acne while minimising the risk of the side effects sometimes observed when the drug is taken orally.Subjects of both sexes, aged 12 to 45, who currently suffer with mild to moderate acne will be invited to participate in the study. Following a four week wash out period, during which they will be asked not to use any acne treatments or medicated facial wash products, subjects will be randomly allocated one of the three study treatments to apply twice daily to the face for twelve weeks. The study product is to be used along side their normal facial washing routine. Safety and efficacy assessments will be made after 4, 8 and 12 weeks of treatment. The research is funded by Warner Chilcott Company, Inc. Subjects will be recruited by a Contract Research Organisation based in NorthWest UK.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  08/H0301/147

• Date of REC Opinion

  6 Jan 2009

• REC opinion

  Further Information Favourable Opinion