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
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu klinické zkoušky, fáze III, klinické zkoušky, fáze IV, srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie
PubMed
31150711
DOI
10.1016/j.jaad.2019.05.063
PII: S0190-9622(19)30867-9
Knihovny.cz E-zdroje
- Klíčová slova
- clear, combination therapy, concomitant use, doxycycline, individualized treatment, ivermectin, rosacea, rosacea treatment, severe rosacea,
- MeSH
- aplikace orální MeSH
- časové faktory MeSH
- dospělí MeSH
- doxycyklin aplikace a dávkování MeSH
- ivermektin aplikace a dávkování MeSH
- kombinovaná farmakoterapie metody MeSH
- kvalita života MeSH
- léky s prodlouženým účinkem aplikace a dávkování MeSH
- lidé MeSH
- placeba aplikace a dávkování MeSH
- pleťový krém aplikace a dávkování MeSH
- rosacea komplikace diagnóza farmakoterapie MeSH
- spokojenost pacientů MeSH
- stupeň závažnosti nemoci MeSH
- tobolky MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- klinické zkoušky, fáze IV MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Názvy látek
- doxycyklin MeSH
- ivermektin MeSH
- léky s prodlouženým účinkem MeSH
- placeba MeSH
- tobolky MeSH
BACKGROUND: Randomized controlled studies of combination therapies in rosacea are limited. OBJECTIVE: Evaluate the efficacy and safety of combining ivermectin 1% cream (IVM) and doxycycline 40-mg modified-release capsules (ie, 30-mg immediate-release and 10-mg delayed-release beads) (DMR) versus IVM and placebo 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] score, 4) to receive either IVM and DMR (combination arm) or IVM and placebo (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 = .032]) and IGA score (P = .032). Combination therapy had a faster onset of action as of week 4; it significantly increased the number of subjects achieving an IGA score of 0 (11.9% vs 5.1% [P = .043]) and 100% lesion reduction (17.8% vs 7.2% [P = .006]) at week 12. Both treatments reduced the Clinician's Erythema Assessment score, stinging/burning, flushing episodes, Dermatology Life Quality Index score, and ocular signs/symptoms and were well tolerated. LIMITATIONS: The duration of the 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 cases of severe rosacea.
Ambroziak Clinic Warsaw Poland
CentroDerm Clinic Wuppertal Germany; Faculty of Health University of Witten Herdecke Witten Germany
Department of Dermatology and Allergology University of Szeged Szeged Hungary
Department of Dermatology Faculty of Medicine University of Debrecen Debrecen Hungary
Department of Dermatology Tübingen University Hospital Tübingen Germany
Department of Medicine University of Toronto Toronto Ontario Canada
Dermatology Center Prague Czech Republic
Galderma R and D Sophia Antipolis France
JDR Dermatology Research Thomas Dermatology Las Vegas Nevada
Johnson Dermatology Fort Smith Arkansas
Medical Evidence Galderma S A Vevey Switzerland
Niepubliczny Zakład Opieki Zdrowotnej multiMedica Wrocław Poland
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