Phase 4
N=273
Oracea Soolantra Association in Participants With Severe Rosacea
Rosacea
Bottom Line
View on ClinicalTrials.gov: NCT03075891 ↗Enrolled (actual)
273
Serious AEs
0.7%
Results posted
Nov 2019
Primary outcome: Primary: Percent Change From Baseline in Inflammatory Lesion Count at Week 12 — -80.29; -73.56 percent change — p=0.032
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ivermectin 1% cream (Drug); Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules (Drug); Oral placebo capsules (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Inflammatory Lesion Count at Week 12 |
-80.29; -73.56 | 0.032 sig |
| SECONDARY Percent Change From Baseline in Inflammatory Lesion Count at Weeks 4 and 8 |
-48.15; -39.27; -69.14; -61.44 | — |
| SECONDARY Percentage of Participants With Clear Inflammatory Lesions at Week 12 |
17.8; 7.2 | — |
| SECONDARY Percentage of Participants With 100 Percent (%) Reduction in Inflammatory Lesions at Weeks 4, 8 and 12 |
1.5; 0.0; 98.5; 100.0; 5.2; 2.9 | — |
| SECONDARY Clinician's Erythema Assessment (CEA) Total Score at Weeks 4, 8 and 12 |
2.47; 2.56; 1.85; 1.97; 1.51; 1.58 | — |
| SECONDARY Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12 |
0.7; 0.7; 16.3; 12.3; 31.9; 34.1 | — |
| SECONDARY Investigator's Global Assessment (IGA) Total Score at Weeks 4, 8 and 12 |
2.59; 2.84; 1.78; 2.04; 1.34; 1.57 | — |
| SECONDARY Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12 |
1.5; 0.7; 11.1; 5.1; 25.2; 23.9 | — |
| SECONDARY Stinging/Burning Severity Score at Weeks 4, 8 and 12 |
0.73; 0.65; 0.41; 0.44; 0.31; 0.33 | — |
| SECONDARY Percentage of Participants in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12 |
47.4; 50.0; 32.6; 36.2; 19.3; 12.3 | — |
| SECONDARY Global Improvement Total Score at Week 12 (Last Visit/Early Termination) |
1.79; 1.81 | — |
| SECONDARY Percentage of Participants in Each Global Improvement Score Category at Week 12 (Last Visit/Early Termination) |
7.9; 6.2; 39.7; 44.2; 31.7; 25.6 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
27; 50; 1; 1 | — |
| SECONDARY Dermatology Life Quality Index (DLQI) Questionnaire Total Score at Week 12 (Last Visit/Early Termination Visit) |
1.4; 2.2 | — |
| SECONDARY Percentage of Participants in Each Dermatology Life Quality Index (DLQI) Questionnaire Score Category |
17.8; 18.8; 37.8; 33.3; 27.4; 32.6 | — |
| SECONDARY Percent Change From Baseline in Dermatology Life Quality Index Questionnaire Total Score at Week 12 (Last Visit/Early Termination) |
-59.5; -59.2 | — |
| SECONDARY EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire at Week 12 (Last Visit/Early Termination Visit) |
83.5; 83.0 | — |
| SECONDARY 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) |
80; 84.1; 96.3; 97.8; 85.9; 89.1 | — |
| SECONDARY 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) |
34.1; 34.8; 65.9; 65.2 | — |
| SECONDARY 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 |
0.1; 0.0; 4.2; 2.9; 36.3; 38.2 | — |
| SECONDARY 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) |
0.6; 0.5; 0.5; 0.7 | — |
| SECONDARY Percentage of Participants Who Reported Satisfied for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part A |
48.0; 45.0; 48.0; 46.5; 45.6; 41.1 | — |
| SECONDARY Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part B |
68.5; 70.5; 60.5; 52.7; 58.1; 50.4 | — |
| SECONDARY Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part C |
49.2; 46.5; 41.1; 40.3; 54.0; 48.8 | — |
| SECONDARY Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part D |
48.0; 35.7; 38.2; 34.1; 42.3; 38.0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03075891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.