05 Mar Oracea® Capsules + Soolantra Cream Effective for Inflammatory Rosacea
MedicalResearch.com Interview with:
Dr. James Q. Del Rosso, D.O., FAOCD, Dermatologist
Research Director and Principal Investigator
Del Rosso Dermatology Research Center, Las Vegas, NV
MedicalResearch.com: What is the background for this study? What are the main findings?
- The ANSWER study, a 12-week, randomized, multicenter, Phase 4, Phase 3b in Canada and Europe clinical trial, is the first study of its kind to compare the efficacy and safety of combination therapy with Oracea® (doxycycline, USP) 40 mg Capsules + Soolantra® (ivermectin) Cream, 1% versus Soolantra® (ivermectin) Cream, 1% monotherapy in 273 adults with severe papulopustular rosacea (IGA 4) at clinical trial sites in the United States, Canada and Europe (Czech Republic, Poland, Hungary and Germany).
- Results showed the combination therapy with Oracea Capsules + Soolantra Cream was well tolerated and effective with a faster onset of action than Soolantra Cream given as monotherapy. Key highlights of the study include:
- The mean reduction in percentage of inflammatory lesions from baseline to Week 12 was significant with combination therapy compared to monotherapy (80.29% vs. 73.56%, respectively; p=0.032).
- 5 times as many patients taking combination therapy achieved 100% clearance of inflammatory lesions by Week 12 compared with monotherapy (17.8% vs. 7.2%, respectively; p=0.006).
- Over 2 times as many patients taking combination therapy achieved 100% clear (IGA 0) by Week 12 compared with monotherapy (11.9% vs. 5.1%, respectively; p=0.043).
- Combination therapy was generally well tolerated and no discontinuation of treatments due to side effects.
MedicalResearch.com: Any photosensitivity or food contraindications from Oracea?
Response: Oracea Capsules is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Although this was not observed during the duration of the clinical studies with Oracea Capsules, patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using Oracea Capsules. If patients need to be outdoors while using Oracea Capsules, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician
Response: MedicalResearch.com: What should readers take away from your report?
Response: These new findings from the ANSWER study suggest there are efficacy benefits for some patients treated with the combination of Oracea Capsules + Soolantra Cream compared to Soolantra Cream monotherapy. Combination therapy with Oracea Capsules + Soolantra Cream was shown to be well tolerated and effective with a faster onset of action than Soolantra Cream monotherapy for the treatment of severe rosacea.
Furthermore, this combination of an oral and topical treatment can potentially help patients achieve clear skin (IGA 0).
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: I welcome additional studies of combination therapies for rosacea.
MedicalResearch.com: Is there anything else you would like to add?
Response: Achieving 100% clearance of lesions is important for individuals living with rosacea, as this chronic, visible disease poses a physical, emotional and psychological burden on patients.
Disclosures: Consultant, clinical researcher and speaker for Galderma
Citation: Phase 3b/4 ANSWER study that presented in a poster session at the 2019 American Academy of Dermatology (AAD) Annual Meeting: first randomized clinical trial to compare the combination of Oracea® (doxycycline, USP) 40 mg Capsules, the only approved oral treatment for inflammatory rosacea lesions, plus Soolantra® (ivermectin) Cream, 1%, indicated for the inflammatory lesions of rosacea, against Soolantra® (ivermectin) Cream, 1% administered as monotherapy
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