Systemic isotretinoin in the treatment of rosacea - doxycycline- and placebo-controlled, randomized clinical study.

Abstract

BACKGROUND:

Systemic isotretinoin has been known for decades to be effective in the treatment of severe forms of rosacea, but it must be used off-label because of the lack of evidence-based data.

PATIENTS AND METHODS:

573 patients with rosacea subtype II and III received one of three different dosages of isotretinoin (0.1 mg, 0.3 mg, or 0.5 mg per kg body weight), doxycycline (100 mg daily for 14 days, then 50 mg daily) or placebo in a double-blinded, randomized way for 12 weeks in 35 German centers.

RESULTS:

Isotretinoin 0.3 mg/kg proved to be the most effective dose with significant superiority versus placebo. Isotretinoin 0.3 mg/kg showed also significant non-inferiority versus doxycycline with reduction of lesions of 90 % compared to 83 % with doxycycline. Investigators diagnosed complete remission in 24 % and marked improvement in further 57 % of patients with isotretinoin treatment, in contrast to remission in 14 % and marked improvement in 55 % of patients treated with doxycycline. Isotretinoin 0.3 mg/kg revealed a similar safety profile as for the treatment of acne. Isotretinoin 0.5 mg/kg showed more dermatitis facialis as compared to 0.3 mg/kg.

CONCLUSIONS:

Isotretinoin 0.3 mg/kg is an effective and well-tolerated therapy option for the treatment of rosacea subtype II and III and can therefore be used successfully as an alternative to therapy with oral antibiotics.

• Authors: Harald Gollnick, Ulrike Blume-Peytavi, Eörs Lāszlō Szabó, Karl-Gustav Meyer, Petra Hauptmann, Georg Popp, Michael Sebastian, Thomas Zwingers, Christoph Willers, Renate von der Weth
• Journal: Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG (J Dtsch Dermatol Ges) Vol. 8 Issue 7 Pg. 505-15 (Jul 2010) ISSN: 1610-0387 [Electronic] Germany
• PMID: 20337772 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Dermatologic Agents
• Isotretinoin
• Doxycycline

Topics

• Adult
• Aged
• Aged, 80 and over
• Anti-Bacterial Agents (administration & dosage)
• Dermatologic Agents (administration & dosage)
• Double-Blind Method
• Doxycycline (administration & dosage)
• Female
• Humans
• Injections, Intra-Arterial
• Isotretinoin (administration & dosage)
• Male
• Middle Aged
• Placebo Effect
• Rosacea (diagnosis, drug therapy)
• Treatment Outcome