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 - 09/01/20
, Lajos Kemény, MD, PhD, DSc b, Blanka Havlickova, MD, PhD c, J. Mark Jackson, MD d, e, Marcin Ambroziak, MD f, Charles Lynde, MD g, Melinda Gooderham, MD h, Eva Remenyik, MD, PhD, DSc i, James Del Rosso, DO j, Jolanta Weglowska, MD k, Rajeev Chavda, MD l, Nabil Kerrouche, MSc m, Thomas Dirschka, MD n, o, Sandra Johnson, MD pAbstract |
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.
Il testo completo di questo articolo è disponibile in PDF.Key words : clear, combination therapy, concomitant use, doxycycline, individualized treatment, ivermectin, rosacea, rosacea treatment, severe rosacea
Abbreviations used : AE, CEA, DLQI, DMR, IGA, ITT, IVM, LOCF, PBO, SD
Mappa
| Funding sources: Supported by Galderma. |
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| Disclosure: Dr Schaller is a Galderma and Marpinion advisory board member; speaker for AbbVie, Bayer Healthcare, Galderma, and La Roche-Posay; recipient of research grants from Galderma and Bayer HealthCare; and investigator for GSK and Galderma. Dr Johnson is a Galderma advisory board member; Allermed/Greer/Nielsen, Regeneron and Sanofi Genzyme advisor; national speaker for Celgene, Allergan, and Candela Syneron; speaker for Galderma, Regeneron, and Sanofi Genzyme; and investigator for Galderma, Leo, Eli Lilly and Company, BMS, Foamix, and Gage. Dr Jackson is a Galderma investigator and advisor and Accuitis advisor. Dr Kemény is an investigator for Galderma and a Janssen, Abbvie, Novartis, and Eli Lilly and Company advisory board member. Dr Remenyik is a Galderma investigator. Dr Del Rosso is a researcher for Galderma, BiopharmX, Foamix, and Leo Pharma (Bayer Dermatology); Galderma advisory board member; speaker for Galderma, Leo Pharma (Bayer Dermatology), Mayne Pharma, and Almirall; and consultant for Leo Pharma (Bayer Dermatology), Mayne Pharma, Almirall, and Hovione. Dr Weglowska is an investigator for Galderma, Amgen, Sun Pharma, UCB, Regeneron, Leo Pharma, and Dermira and a Galderma advisory board member. Dr Gooderham is an investigator, speaker, and advisory board member for Galderma, Leo Pharma, and Valeant. Dr Ambroziak is an investigator for Galderma. Dr Lynde is an investigator, speaker, and advisory board member for Galderma, Leo Pharma, and Valeant/Bausch Health. Dr Havlickova is an investigator for Galderma. Dr Dirschka is an investigator for Galderma and has received research support from Almirall, Biofrontera, Galderma, Meda, and Schulze & Böhm GmbH. Dr Chavda is an employee of Galderma. Mr Kerrouche is a former employee of Galderma. No other conflicts of interest were declared. |
Vol 82 - N° 2
P. 336-343 - febbraio 2020 Ritorno al numero
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