DOMINO, doxycycline 40mg vs minocycline 100mg in the treatment of rosacea: a randomised, single blinded, non-inferiority trial, comparing efficacy and safety

Summary

Background

There is lack of evidence for minocycline in the treatment of rosacea.

Objectives

To compare the efficacy and safety of doxycycline 40mg versus minocycline 100mg in papulopustular rosacea.

Methods

In this randomised single centre, 1:1 allocation, assessor blinded, non-inferiority trial, patients with a mild to severe papulopustular rosacea, were randomly allocated to either oral doxycycline 40mg or minocycline 100mg for a 16-week period with 12 weeks of follow up.

Our primary outcomes were the change in lesion count and change in patient's Health Related Quality of Life (HRQoL): RosaQoL scores.

Our secondary outcomes were: Patient's Global Assessment (PaGA) success ("excellent" or "good" improvement), Investigator Global Assessment (IGA) success ("clear" or "near clear"), Clinicians Erythema Assessment (CEA) success (at least one point decrease), the relapse rate at follow up and safety profile of the treatment drugs.

Intention to treat (ITT) and per protocol analyses (PPA) were performed.

Results

Of the 80 patients randomised, (40 for minocycline and 40 for doxycycline) 71 patients were treated for 16 weeks. 68 patients completed the study.

At week 16, the median change in lesion count was comparable in both groups: doxycycline versus minocycline respectively 13 versus 14 lesions less. (Non-inferiority difference 3, 90% Confidence interval (CI) -2 to 8). The RosaQoL scores were decreased for both doxycycline and minocycline, respectively 0.62 and 0.86. (Non-inferiority difference 0.15, 90% CI -0.09 to 0.42).

Secondary outcomes were comparable except for IGA success, which was assessed significantly more often in the minocycline group than in the doxycycline group (respectively 60% and 17.5%; p<0.001).

At week 28, outcomes were comparable, except for RosaQoL scores and PaGA, which were significantly different in favour of minocycline (P=0.005 and P=0.043 respectively), and less relapses were recorded in the minocycline group than in the doxycycline group (respectively 6.7% and 48%; p<0.001). In this study no serious adverse reactions (SAEs) were reported.

Conclusions

Minocycline 100mg is non-inferior to doxycycline 40mg in efficacy over a 16- week treatment period. Furthermore, at follow up, RosaQoL scores and PaGA were statistically significantly more improved in the minocycline group than in the doxycycline group, and minocycline 100mg gives longer remission than doxycycline 40mg. In this study there was no significant difference in safety between these treatments, however, based on previous literature minocycline has a lower risk/benefit ratio than doxycycline. Minocycline 100mg may be a good alternative treatment for those patients who, for any reason, are unable or unwilling to take doxycycline 40mg.

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