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Oracea Soolantra Association in Patients With Severe Rosacea (ANSWER)

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ClinicalTrials.gov Identifier: NCT03075891
Recruitment Status : Active, not recruiting
First Posted : March 9, 2017
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Galderma

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.

Condition or disease Intervention/treatment Phase
Rosacea Drug: Ivermectin 1% cream Drug: Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules Other: Oral placebo capsules Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : February 15, 2018
Estimated Study Completion Date : February 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: Ivermectin 1% cream + Doxycycline 40 mg MR capsules 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

Placebo Comparator: Ivermectin 1% cream + Oral placebo capsules 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

Other: Oral placebo capsules
1 Capsule once-daily for 12 weeks




Primary Outcome Measures :
  1. Efficacy (Percent change from Baseline in Inflammatory Lesion count) [ Time Frame: Week 12 ]
    Percent change from Baseline in Inflammatory Lesion count



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075891


Locations
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United States, Arkansas
Private Practice
Fort Smith, Arkansas, United States, 72916
United States, California
Private practice
Sacramento, California, United States, 95819
United States, Florida
Private practice
Boca Raton, Florida, United States, 33486
United States, Kentucky
Private practice
Louisville, Kentucky, United States, 40202
Private practice
Louisville, Kentucky, United States, 40241
United States, Louisiana
Private Practice
Metairie, Louisiana, United States, 70001
United States, Nebraska
Private practice
Omaha, Nebraska, United States, 68144
United States, Nevada
Private practice
Las Vegas, Nevada, United States, 89148
United States, Texas
Private practice
Pflugerville, Texas, United States, 78660
Canada
Private practice
Markham, Canada
Private practice
Montréal, Canada
Private practice
Peterborough, Canada
Private practice
Richmond Hill, Canada
Private practice
Waterloo, Canada
Hungary
Private practice
Budapest, Hungary
University
Debrecen, Hungary
Hospital
Miskolc, Hungary
Private practice
Pécel, Hungary
University
Pécs, Hungary
University
Szeged, Hungary
Private practice
Szolnok, Hungary
Sponsors and Collaborators
Galderma

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Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT03075891     History of Changes
Other Study ID Numbers: RD.03.SPR.113322
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rosacea
Skin Diseases
Doxycycline
Ivermectin
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents