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A randomized phase 3b/4 study to evaluate concomitant use of topical ivermectin 1% cream and doxycycline 40 mg modified-release capsules versus topical ivermectin 1% cream and placebo in the treatment of severe rosacea.

J Am Acad Dermatol. 2019 May 28;:

Authors: Schaller M, Kemeny L, Havlickova B, Jackson JM, Ambroziak M, Lynde C, Gooderham M, Remenyik E, Del Rosso J, Weglowska J, Chavda R, Kerrouche N, Dirschka T, Johnson S

Abstract
BACKGROUND: Randomized controlled studies of combination therapies in rosacea are limited.
OBJECTIVE: Evaluate efficacy and safety of combining ivermectin 1% cream (IVM) and doxycycline 40 mg modified-release capsules∗ (DMR) versus IVM and placebo (PBO) for treatment of severe rosacea.
METHODS: This 12-week, multicenter, randomized, investigator-blinded, parallel-group comparative study randomized adult subjects with severe rosacea (Investigator's Global Assessment [IGA]=4) to either IVM and DMR (combination arm) or IVM and PBO (monotherapy).
RESULTS: A total of 273 subjects participated. IVM and DMR displayed superior efficacy in reduction of inflammatory lesions (-80.3% vs. -73.6% for monotherapy, p=0.032) and IGA score (p=0.032). Combination therapy had a faster onset of action as of week 4; it significantly increased the number of subjects achieving IGA 0 (11.9% vs. 5.1%, p=0.043)† and 100% lesion reduction (17.8% vs. 7.2%, p=0.006) at week 12. Both treatments reduced the Clinician's Erythema Assessment score, stinging/burning, flushing episodes, Dermatology Life Quality Index and ocular signs/symptoms, and were well-tolerated.
LIMITATIONS: The duration of study prevented evaluation of potential recurrences or further improvements.
CONCLUSION: Combining IVM and DMR can produce faster responses, improve response rates, and increase patient satisfaction in severe rosacea.

PMID: 31150711 [PubMed - as supplied by publisher]

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