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Oracea Soolantra Association in Participants With Severe Rosacea

NCT03075891 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2021-03-16

Study results available
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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.

Conditions

  • Rosacea

Interventions

DRUG

Ivermectin 1% cream

Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks

DRUG

Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules

1 Capsule once-daily for 12 weeks

OTHER

Oral placebo capsules

1 Capsule once-daily for 12 weeks

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-05
Primary Completion
2018-02-08
Completion
2018-02-08
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03075891 on ClinicalTrials.gov