Martin Schaller1, Lajos Kemény2, Blanka Havlickova3, J Mark Jackson4, Marcin Ambroziak5, Charles Lynde6, Melinda Gooderham7, Eva Remenyik8, James Del Rosso9, Jolanta Weglowska10, Rajeev Chavda11, Nabil Kerrouche12, Thomas Dirschka13, Sandra Johnson14. 1. Department of Dermatology, Tübingen University Hospital, Tübingen, Germany. Electronic address: martin.schaller@med.uni-tuebingen.de. 2. Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary. 3. Dermatology Center, Prague, Czech Republic. 4. Division of Dermatology, University of Louisville, Louisville, Kentucky; Forefront Dermatology, Louisville, Kentucky. 5. Ambroziak Clinic, Warsaw, Poland. 6. Department of Medicine, University of Toronto, Toronto, Ontario, Canada. 7. SKiN Centre for Dermatology, Peterborough, Ontario, Canada. 8. Department of Dermatology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary. 9. JDR Dermatology Research/Thomas Dermatology, Las Vegas, Nevada. 10. Niepubliczny Zakład Opieki Zdrowotnej multiMedica, Wrocław, Poland. 11. Medical Evidence, Galderma S.A., Vevey, Switzerland. 12. Galderma R&D, Sophia Antipolis, France. 13. CentroDerm-Clinic, Wuppertal, Germany; Faculty of Health, University of Witten-Herdecke, Witten, Germany. 14. Johnson Dermatology, Fort Smith, Arkansas.
Abstract
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 eitherIVM 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.
RCT Entities:
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.
Authors: Martin Schaller; Thomas Dirschka; Sol-Britt Lonne-Rahm; Giuseppe Micali; Linda F Stein Gold; Jerry Tan; James Del Rosso Journal: Acta Derm Venereol Date: 2021-10-31 Impact factor: 3.875
Authors: Esther J van Zuuren; Bernd W M Arents; Mireille M D van der Linden; Sofieke Vermeulen; Zbys Fedorowicz; Jerry Tan Journal: Am J Clin Dermatol Date: 2021-03-23 Impact factor: 7.403