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.

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.

Randomized controlled studies of combination therapies in rosacea are limited.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.This 12-week, multicenter, randomized,...

Teljes leírás

Elmentve itt :
Bibliográfiai részletek
Szerzők: Schaller Martin
Kemény Lajos
Havlickova Blanka
Jackson Mark J.
Ambroziak Marcin
Lynde Charles
Gooderham Melinda
Remenyik Éva
Del Rosso James
Weglowska Jolanta
Chavda Rajeev
Kerrouche Nabil
Dirschka Thomas
Johnson Sandra
Dokumentumtípus: Cikk
Megjelent: 2020
Sorozat:JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY 82 No. 2
doi:10.1016/j.jaad.2019.05.063

mtmt:30746290
Online Access:http://publicatio.bibl.u-szeged.hu/20074
Leíró adatok
Tartalmi kivonat:Randomized controlled studies of combination therapies in rosacea are limited.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.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).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.The duration of study prevented evaluation of potential recurrences or further improvements.Combining IVM and DMR can produce faster responses, improve response rates, and increase patient satisfaction in severe rosacea.
Terjedelem/Fizikai jellemzők:336-343
ISSN:0190-9622

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