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Oracea Soolantra Association in Patients With Severe Rosacea (ANSWER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE March 6, 2017
First Posted Date  ICMJE March 9, 2017
Last Update Posted Date January 12, 2018
Actual Study Start Date  ICMJE July 5, 2017
Estimated Primary Completion Date February 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2017)
Efficacy (Percent change from Baseline in Inflammatory Lesion count) [ Time Frame: Week 12 ]
Percent change from Baseline in Inflammatory Lesion count
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03075891 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oracea Soolantra Association in Patients With Severe Rosacea
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rosacea
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Ivermectin 1% cream + Doxycycline 40 mg MR capsules
    Interventions:
    • Drug: Ivermectin 1% cream
    • Drug: Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules
  • Placebo Comparator: Ivermectin 1% cream + Oral placebo capsules
    Interventions:
    • Drug: Ivermectin 1% cream
    • Other: Oral placebo capsules
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 8, 2017)
270
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 15, 2018
Estimated Primary Completion Date February 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Hungary,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03075891
Other Study ID Numbers  ICMJE RD.03.SPR.113322
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Galderma
Study Sponsor  ICMJE Galderma
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Galderma
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP