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
Language English Country United States Media print-electronic
Document type Clinical Trial, Phase III, Clinical Trial, Phase IV, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial
PubMed
31150711
DOI
10.1016/j.jaad.2019.05.063
PII: S0190-9622(19)30867-9
Knihovny.cz E-resources
- Keywords
- clear, combination therapy, concomitant use, doxycycline, individualized treatment, ivermectin, rosacea, rosacea treatment, severe rosacea,
- MeSH
- Administration, Oral MeSH
- Time Factors MeSH
- Adult MeSH
- Doxycycline administration & dosage MeSH
- Ivermectin administration & dosage MeSH
- Drug Therapy, Combination methods MeSH
- Quality of Life MeSH
- Delayed-Action Preparations administration & dosage MeSH
- Humans MeSH
- Placebos administration & dosage MeSH
- Skin Cream administration & dosage MeSH
- Rosacea complications diagnosis drug therapy MeSH
- Patient Satisfaction MeSH
- Severity of Illness Index MeSH
- Capsules MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Clinical Trial, Phase IV MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
- Names of Substances
- Doxycycline MeSH
- Ivermectin MeSH
- Delayed-Action Preparations MeSH
- Placebos MeSH
- Capsules 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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