were excluded from the analysis (n=1 due to failure to follow protocol, and n=2 were lost to follow-up). Data were analyzed for differences by mean score with Student's t-test and percent of respondents with Fisher's Exact Test using SAS Software 9.4.
RESULTS
Subjects were mean age 62 (range 29-85), 70% female, and 93% Caucasian. Mean adherence was 62% over treatment period. At baseline, mean IGA and PSA were both 2.4. A total of 19/27 subjects had >1 rosacea clinical presentation. At three-month follow-up, mean IGA was 1.4 and PSA 1.5 (P<0.0001 and P<0.001, respectively). The severity of the erythematotelangiectatic, papulopustular, and phymatous presentations improved from baseline (9 moderate, 13 mild, and 5 absent to 1 moderate, 21 mild, and 5 absent, P<0.05; 8 moderate, 13 mild, and 6 absent to 1 moderate, 11 mild, and 14 absent, P<0.01; and 1 moderate, 9 mild, and 17 absent to 0 moderate, 3 mild, and 24 absent; P=0.054, respectively) (Figure 1). Adverse events were reported (n=4 subjects) and included burning or stinging (n=3), scarring, dryness, itching, and swelling (n=1 for all).
DISCUSSION
In our cohort, despite incomplete adherence, IVM improved the severity of the erythematotelangiectatic, papulopustular, and phymatous rosacea presentations. Our study was powered to assess large differences in adherence and provided only a limited cohort and no control group for assessing efficacy across rosacea types in this secondary analysis. The Demodex folliculorum mite is involved in the pathogenesis of rosacea, not limited to papulopustular type.2,5 Thus, IVM may target rosacea's pathogenesis, regardless of presentation.2,5 While current literature largely evaluates efficacy of IVM in the papulopustular presentation, results from our cohort suggest IVM may be efficacious in the treatment of the erythematotelangiectatic and phymatous presentations. Our findings support the possibility IVM may have efficacy for all rosacea presentations.
DISCLOSURES
Feldman has received research, speaking, and/or consulting support from a variety of companies including Galderma, GSK/ Stiefel, Almirall, Leo Pharma, Baxter, Boeringer Ingelheim, Mylan, Celgene, Pfizer, Valeant, Taro, Abbvie, Cosmederm, Anacor, Astellas, Janssen, Lilly, Merck, Merz, Novartis, Regeneron, Sanofi, Novan, Parion, Qurient, National Biological Corporation, Caremark, Advance Medical, Sun Pharma, Suncare Research, Informa, UpToDate, and National Psoriasis Foundation. He is the founder and majority owner of www.DrScore.com and founder and part owner of Causa Research, a company dedicated to enhancing patients' adherence to treatment. Singh, Perche, Kelly, Cook, Balogh, and Richardson have no conflicts of interest to disclose.
IRB approval status: Reviewed and approved by Wake Forest University Health Sciences; approval IRB00062694
Funding sources: Funded by Galderma.
IRB approval status: Reviewed and approved by Wake Forest University Health Sciences; approval IRB00062694
Funding sources: Funded by Galderma.
REFERENCES
1. Ebbelaar CCF, Venema AW, Van Dijk MR. Topical ivermectin in the treatment of papulopustular rosacea: a systematic review of evidence and clinical guideline recommendations. Dermatol Ther (Heidelb). 2018;8(3):379-387. doi: 10.1007/s13555-018-0249-y.
2. Schaller M, Gonser L, Belge K, et al. Dual anti-inflammatory and anti-parasitic action of topical ivermectin 1% in papulopustular rosacea. J Eur Acad Dermatol Venereol. 2017;31(11):1907-1911. doi: 10.1111/jdv.14437.
3. Schaller M, Kemeny L, Havlickova B, et al. 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. J Am Acad Dermatol. 2020;82(2):336-343. doi: 10.1016/j.jaad.2019.05.063.
4. Husein-El, Ahmed H, Steinhoff M. Efficacy of topical ivermectin and impact on quality of life in patients with papulopustular rosacea: A systematic review and meta-analysis. Dermatol Ther. 2020;33(1):e13203. doi: 10.1111/ dth.13203.
5. Chang YS, Huang YC. Role of Demodex mite infestation in rosacea: A systematic review and meta-analysis. Am Acad Dermatol. 2017;77(3):441-447.e6. doi: 10.1016/j.jaad.2017.03.040.
2. Schaller M, Gonser L, Belge K, et al. Dual anti-inflammatory and anti-parasitic action of topical ivermectin 1% in papulopustular rosacea. J Eur Acad Dermatol Venereol. 2017;31(11):1907-1911. doi: 10.1111/jdv.14437.
3. Schaller M, Kemeny L, Havlickova B, et al. 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. J Am Acad Dermatol. 2020;82(2):336-343. doi: 10.1016/j.jaad.2019.05.063.
4. Husein-El, Ahmed H, Steinhoff M. Efficacy of topical ivermectin and impact on quality of life in patients with papulopustular rosacea: A systematic review and meta-analysis. Dermatol Ther. 2020;33(1):e13203. doi: 10.1111/ dth.13203.
5. Chang YS, Huang YC. Role of Demodex mite infestation in rosacea: A systematic review and meta-analysis. Am Acad Dermatol. 2017;77(3):441-447.e6. doi: 10.1016/j.jaad.2017.03.040.
AUTHOR CORRESPONDENCE
Rohan Singh BS rs.rohansingh@outlook.com
