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Efficacy and safety of ivermectin 1% cream in treatment of papulopustular rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies.
J Drugs Dermatol. 2014 Mar; 13(3):316-23.JD

Abstract

BACKGROUND

Treatments for papulopustular rosacea (PPR) are limited.

OBJECTIVE

To demonstrate the efficacy and safety of once-daily ivermectin 1% cream in subjects with moderate to severe PPR.

METHODS

Two identically designed, randomized, double-blind, controlled studies of ivermectin 1% cream (IVM 1%) or vehicle once daily for 12 weeks were conducted in subjects with moderate to severe PPR. Efficacy assessments were Investigator's Global Assessment (IGA) of disease severity and inflammatory lesion counts. Safety assessments included incidence of adverse events (AEs) and local tolerance parameters. Subjects evaluated their rosacea and completed satisfaction and quality of life (QoL) questionnaires.

RESULTS

In both studies, a greater proportion of subjects in the IVM 1% group achieved treatment success (IGA "clear" or "almost clear"): 38.4% and 40.1% vs 11.6% and 18.8% for vehicle (both P<.001), respectively. Ivermectin was superior to vehicle in terms of reduction from baseline in inflammatory lesion counts (76.0% and 75.0% vs 50.0% for both vehicle groups, respectively). For all endpoints, starting at week 4 and continuing through week 12, IVM 1% was statistically significantly superior (P<.001). Fewer subjects treated by IVM 1% reported dermatologic AEs, and a higher proportion of subjects were observed to have no skin dryness or itching compared to vehicle. Significantly more subjects receiving IVM 1% reported having an "excellent" or "good" improvement, along with an improved QoL.

CONCLUSION

Ivermectin 1% cream was effective and safe in treating inflammatory lesions of papulopustular rosacea.

Authors

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Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24595578

Citation

Stein, Linda, et al. "Efficacy and Safety of Ivermectin 1% Cream in Treatment of Papulopustular Rosacea: Results of Two Randomized, Double-blind, Vehicle-controlled Pivotal Studies." Journal of Drugs in Dermatology : JDD, vol. 13, no. 3, 2014, pp. 316-23.
Stein L, Kircik L, Fowler J, et al. Efficacy and safety of ivermectin 1% cream in treatment of papulopustular rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies. J Drugs Dermatol. 2014;13(3):316-23.
Stein, L., Kircik, L., Fowler, J., Tan, J., Draelos, Z., Fleischer, A., Appell, M., Steinhoff, M., Lynde, C., Liu, H., & Jacovella, J. (2014). Efficacy and safety of ivermectin 1% cream in treatment of papulopustular rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies. Journal of Drugs in Dermatology : JDD, 13(3), 316-23.
Stein L, et al. Efficacy and Safety of Ivermectin 1% Cream in Treatment of Papulopustular Rosacea: Results of Two Randomized, Double-blind, Vehicle-controlled Pivotal Studies. J Drugs Dermatol. 2014;13(3):316-23. PubMed PMID: 24595578.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of ivermectin 1% cream in treatment of papulopustular rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies. AU - Stein,Linda, AU - Kircik,Leon, AU - Fowler,Joseph, AU - Tan,Jerry, AU - Draelos,Zoe, AU - Fleischer,Alan, AU - Appell,Melanie, AU - Steinhoff,Martin, AU - Lynde,Charles, AU - Liu,Hong, AU - Jacovella,Jean, PY - 2014/3/6/entrez PY - 2014/3/7/pubmed PY - 2014/12/15/medline SP - 316 EP - 23 JF - Journal of drugs in dermatology : JDD JO - J Drugs Dermatol VL - 13 IS - 3 N2 - BACKGROUND: Treatments for papulopustular rosacea (PPR) are limited. OBJECTIVE: To demonstrate the efficacy and safety of once-daily ivermectin 1% cream in subjects with moderate to severe PPR. METHODS: Two identically designed, randomized, double-blind, controlled studies of ivermectin 1% cream (IVM 1%) or vehicle once daily for 12 weeks were conducted in subjects with moderate to severe PPR. Efficacy assessments were Investigator's Global Assessment (IGA) of disease severity and inflammatory lesion counts. Safety assessments included incidence of adverse events (AEs) and local tolerance parameters. Subjects evaluated their rosacea and completed satisfaction and quality of life (QoL) questionnaires. RESULTS: In both studies, a greater proportion of subjects in the IVM 1% group achieved treatment success (IGA "clear" or "almost clear"): 38.4% and 40.1% vs 11.6% and 18.8% for vehicle (both P<.001), respectively. Ivermectin was superior to vehicle in terms of reduction from baseline in inflammatory lesion counts (76.0% and 75.0% vs 50.0% for both vehicle groups, respectively). For all endpoints, starting at week 4 and continuing through week 12, IVM 1% was statistically significantly superior (P<.001). Fewer subjects treated by IVM 1% reported dermatologic AEs, and a higher proportion of subjects were observed to have no skin dryness or itching compared to vehicle. Significantly more subjects receiving IVM 1% reported having an "excellent" or "good" improvement, along with an improved QoL. CONCLUSION: Ivermectin 1% cream was effective and safe in treating inflammatory lesions of papulopustular rosacea. SN - 1545-9616 UR - https://brain.unboundmedicine.com/medline/citation/24595578/Efficacy_and_safety_of_ivermectin_1_cream_in_treatment_of_papulopustular_rosacea:_results_of_two_randomized_double_blind_vehicle_controlled_pivotal_studies_ DB - PRIME DP - Unbound Medicine ER -