Clinical trial NCT03075891: Oracea Soolantra Association in Participants With Severe Rosacea
Official title: Efficacy Comparison of Ivermectin 1% Topical Cream Associated With Doxycycline 40 mg Modified Release (MR) Capsules Versus Ivermectin 1% Topical Cream Associated With Placebo in the Treatment of Severe Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rosacea
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2017-03-09
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to evaluate the efficacy of Ivermectin 1% topical cream associated with Doxycycline 40 mg Modified release (MR) capsules versus Ivermectin 1% topical cream associated with Placebo in the treatment of severe Rosacea.


Eligibility criteria: Inclusion Criteria:

* Male or female subject age ≥ 18 years or older;
* Subject with a minimum of 20 but not more than 70 inflammatory lesions (papules and pustules) of rosacea on the face at Baseline visit;
* Subject with severe rosacea with papulopustular lesions (according to the Investigator's Global Assessment (IGA) score rated 4);
* Female subjects of childbearing potential with a negative urine pregnancy test (UPT);
* Female subjects of childbearing potential must practice a highly effective method of contraception during the study.

Exclusion Criteria:

* Subjects with particular forms of rosacea or other concomitant facial dermatoses that may be confounded with rosacea;
* Subjects with more than 2 nodules of rosacea on the face;
* Subjects with any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or with optimal participation in the study or would present a significant risk to the subject;
* Subjects with known or suspected allergies or sensitivities to any component of the investigational and non-investigational products, including the active ingredients doxycycline and ivermectin.

Primary outcomes:
measure: Percent Change From Baseline in Inflammatory Lesion Count at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percent Change From Baseline in Inflammatory Lesion Count at Weeks 4 and 8
timeFrame: Baseline, Weeks 4 and 8
measure: Percentage of Participants With Clear Inflammatory Lesions at Week 12
timeFrame: Week 12
measure: Percentage of Participants With 100 Percent (%) Reduction in Inflammatory Lesions at Weeks 4, 8 and 12
timeFrame: Weeks 4, 8 and 12
measure: Clinician's Erythema Assessment (CEA) Total Score at Weeks 4, 8 and 12
timeFrame: Weeks 4, 8 and 12
measure: Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12
timeFrame: Weeks 4, 8 and 12
measure: Investigator's Global Assessment (IGA) Total Score at Weeks 4, 8 and 12
timeFrame: Weeks 4, 8 and 12
measure: Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12
timeFrame: Weeks 4, 8 and 12
measure: Stinging/Burning Severity Score at Weeks 4, 8 and 12
timeFrame: Weeks 4, 8 and 12
measure: Percentage of Participants in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12
timeFrame: Weeks 4, 8 and 12
measure: Global Improvement Total Score at Week 12 (Last Visit/Early Termination)
timeFrame: Week 12 (last visit/early termination)
measure: Percentage of Participants in Each Global Improvement Score Category at Week 12 (Last Visit/Early Termination)
timeFrame: Week 12 (last visit/early termination)
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From the signing of the informed consent form (ICF) up to Week 12
measure: Dermatology Life Quality Index (DLQI) Questionnaire Total Score at Week 12 (Last Visit/Early Termination Visit)
timeFrame: Week 12 (last visit/early termination)
measure: Percentage of Participants in Each Dermatology Life Quality Index (DLQI) Questionnaire Score Category
timeFrame: Baseline, Week 12 (last visit/early termination)
measure: Percent Change From Baseline in Dermatology Life Quality Index Questionnaire Total Score at Week 12 (Last Visit/Early Termination)
timeFrame: Baseline, Week 12 (last visit/early termination)
measure: EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire at Week 12 (Last Visit/Early Termination Visit)
timeFrame: Week 12/Last visit or early termination visit
measure: Percentage of Participants in Each EuroQol-5 Dimension-5 Level Questionnaire Questions Who Reported No Problems at Baseline and Week 12 (Last Visit/Early Termination)
timeFrame: Baseline, Week 12 (last visit/early termination)
measure: Percentage of Participants Reported Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire for Currently Employed Question at Week 12 (Last Visit/Early Termination Visit)
timeFrame: Week 12 (Last visit/early termination visit)
measure: Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire - Hours Missed at Work, Impact to Productivity at Work and Daily Activities at Week 12
timeFrame: Week 12 (Last visit/Early termination visit)
measure: Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire (How Much Rosacea Affect Productivity at Work, How Much Rosacea Affect Daily Activity) at Week 12 (Last Visit/Early Termination Visit)
timeFrame: Week 12 (Last visit/Early termination visit)
measure: Percentage of Participants Who Reported Satisfied for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part A
timeFrame: Week 12 (Last visit/early termination visit)
measure: Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part B
timeFrame: Week 12 (Last visit/early termination visit)
measure: Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part C
timeFrame: Week 12 (Last visit or early termination visit)
measure: Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part D
timeFrame: Week 12 (Last visit/early termination visit)
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Private Practice
state: Arkansas
city: Sacramento
country: United States
facility: Private practice
state: California
city: Boca Raton
country: United States
facility: Private practice
state: Florida
city: Louisville
country: United States
facility: Private practice
state: Kentucky
city: Louisville
country: United States
facility: Private practice
state: Kentucky
city: Metairie
country: United States
facility: Private Practice
state: Louisiana
city: Omaha
country: United States
facility: Private practice
state: Nebraska
city: Las Vegas
country: United States
facility: Private practice
state: Nevada
city: Pflugerville
country: United States
facility: Private practice
state: Texas
city: Markham
country: Canada
facility: Private practice
city: Montréal
country: Canada
facility: Private practice
city: Peterborough
country: Canada
facility: Private practice
city: Richmond Hill
country: Canada
facility: Private practice
city: Waterloo
country: Canada
facility: Private practice
city: Budapest
country: Hungary
facility: Private practice
city: Debrecen
country: Hungary
facility: University
city: Miskolc
country: Hungary
facility: Hospital
city: Pécel
country: Hungary
facility: Private practice
city: Pécs
country: Hungary
facility: University
city: Szeged
country: Hungary
facility: University
city: Szolnok
country: Hungary
facility: Private practice
Study officials:
References: