Guy Webster1, Martin Schaller2, Jerry Tan3, J Mark Jackson4, Nabil Kerrouche5, Gregor Schäfer6. 1. a Department of Dermatology , Thomas Jefferson University , Philadelphia , PA , USA. 2. b Department of Dermatology , Eberhard Karls University , Tübingen , Germany. 3. c University of Western Ontario, London, Ontario and Windsor Clinical Research Inc , Windsor , Ontario , Canada. 4. d Division of Dermatology, Forefront Dermatology , University of Louisville , KY , USA. 5. e Galderma R&D , Sophia Antipolis , France. 6. f Galderma International , Paris , France.
Abstract
BACKGROUND:Rosacea treatment success is usually defined as a score of 1 ('almost clear') or 0 ('clear') on the 5-point Investigator Global Assessment (IGA) scale. OBJECTIVE: To evaluate whether, after successful treatment, 'clear' subjects had better outcomes than 'almost clear' subjects. METHODS: A pooled analysis was performed on 1366 rosacea subjects from four randomized controlled trials with IGA before and after treatment (ivermectin, metronidazole or vehicle). Assessments included the Dermatology Life Quality Index (DLQI) questionnaire and subject assessment of rosacea improvement. In one trial, patients were followed after the treatment period to measure time to relapse (IGA score ≥2). RESULTS: At end of treatment, more 'clear' than 'almost clear' subjects had a clinically meaningful difference in DLQI (59% vs. 44%; p < .001) and a final DLQI score of 0-1 indicating no effect on quality of life (84% vs. 66%; p < .001). More 'clear' subjects reported an 'excellent' improvement in their rosacea (77% vs. 42%; p < .001). The median time to relapse was more than 8 months for 'clear' vs. 3 months for 'almost clear' subjects (p < .0001). CONCLUSIONS: Achieving an endpoint of 'clear' (IGA 0) vs. 'almost clear' (IGA 1) is associated with multiple positive patient outcomes, including delayed time to relapse.
RCT Entities:
BACKGROUND: Rosacea treatment success is usually defined as a score of 1 ('almost clear') or 0 ('clear') on the 5-point Investigator Global Assessment (IGA) scale. OBJECTIVE: To evaluate whether, after successful treatment, 'clear' subjects had better outcomes than 'almost clear' subjects. METHODS: A pooled analysis was performed on 1366 rosacea subjects from four randomized controlled trials with IGA before and after treatment (ivermectin, metronidazole or vehicle). Assessments included the Dermatology Life Quality Index (DLQI) questionnaire and subject assessment of rosacea improvement. In one trial, patients were followed after the treatment period to measure time to relapse (IGA score ≥2). RESULTS: At end of treatment, more 'clear' than 'almost clear' subjects had a clinically meaningful difference in DLQI (59% vs. 44%; p < .001) and a final DLQI score of 0-1 indicating no effect on quality of life (84% vs. 66%; p < .001). More 'clear' subjects reported an 'excellent' improvement in their rosacea (77% vs. 42%; p < .001). The median time to relapse was more than 8 months for 'clear' vs. 3 months for 'almost clear' subjects (p < .0001). CONCLUSIONS: Achieving an endpoint of 'clear' (IGA 0) vs. 'almost clear' (IGA 1) is associated with multiple positive patient outcomes, including delayed time to relapse.
Entities:
Keywords:
Clear; inflammatory lesions; pooled analysis; quality of life; rosacea; time to relapse
Authors: James Q Del Rosso; Emil Tanghetti; Guy Webster; Linda Stein Gold; Diane Thiboutot; Richard L Gallo Journal: J Clin Aesthet Dermatol Date: 2020-06-01
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: Marcelle Silva-Abreu; Lupe Carolina Espinoza; María José Rodríguez-Lagunas; María-José Fábrega; Marta Espina; María Luisa García; Ana Cristina Calpena Journal: Int J Mol Sci Date: 2017-11-28 Impact factor: 5.923
Authors: M Schaller; L M C Almeida; A Bewley; B Cribier; J Del Rosso; N C Dlova; R L Gallo; R D Granstein; G Kautz; M J Mannis; G Micali; H H Oon; M Rajagopalan; M Steinhoff; E Tanghetti; D Thiboutot; P Troielli; G Webster; M Zierhut; E J van Zuuren; J Tan Journal: Br J Dermatol Date: 2019-10-16 Impact factor: 9.302