CD5024 and Metronidazole in Papulopustular Rosacea

• Research type

  Research Study

• Full title

  Efficacy and safety of CD5024 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea over 16 weeks treatment, followed by a 36-week extension period

• IRAS ID

  96835

• Contact name

  John Berth-Jones

• Sponsor organisation

  Galderma R&D SNC

• Eudract number

  2011-004791-11

• Research summary

  Papulopustular rosacea (PPR) is a chronic (long-term) skin condition characterized by redness and swelling, papules (small, inflamed pimples) and pustules (pimples containing pus). These symptoms may be associated with a burning and/or stinging sensation. The condition is usually limited to the face (nose, cheeks, chin and forehead), but occasionally may also involve the neck, chest and back. The causes of rosacea are poorly understood. It is thought to arise from a combination of factors. These may be genetic, psychological, hormonal, or medical in origin. Certain foods, medications, exertion or environmental factors can aggravate the symptoms of rosacea. Another cause may be Demodex folliculorum, which are tiny mites that live in or near the hair follicles in both humans and animals. Infestation with Demodex mites is common and usually does not cause any symptoms however occasionally some skin diseases may be caused by the mites. Rosacea appears to be one of them. CD5024, an antiparasitic product (against parasites such as the tiny mites), taken by the oral route, has been commercialised since 1987. The efficacy of CD5024 in human and animal infection due to Demodex folliculorum argues in favour of a probable efficacy of CD5024 in the Papulopustular rosacea where this mite can be involved. This has prompted GALDERMA R&D to formulate a new cream and this is the product which is the subject of this research study. The previous clinical development program provided adequate evidence of safety. Then Galderma R&D decided to continue the CD 5024 development program in the North America and Europe. The study in question is designed to compare the efficacy and safety of CD5024 1% cream applied once daily versus metronidazole (Rozex? cream) 0.75% applied twice daily for 4 months followed by an 8-month extension period to assess the relapse rate.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  12/NW/0034

• Date of REC Opinion

  21 Mar 2012

• REC opinion

  Further Information Favourable Opinion