NCT03075891

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_4

Geographic Reach
3 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

July 5, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2018

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

November 29, 2019

Completed
Last Updated

March 16, 2021

Status Verified

November 1, 2019

Enrollment Period

7 months

First QC Date

March 6, 2017

Results QC Date

September 16, 2019

Last Update Submit

February 23, 2021

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

  • Percent Change From Baseline in Inflammatory Lesion Count at Week 12

    Percent change from baseline in inflammatory lesion count at week 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (that is \[i.e.\] papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 centimeter (cm) in diameter; and Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions.

    Baseline, Week 12

Secondary Outcomes (24)

  • Percent Change From Baseline in Inflammatory Lesion Count at Weeks 4 and 8

    Baseline, Weeks 4 and 8

  • Percentage of Participants With Clear Inflammatory Lesions at Week 12

    Week 12

  • Percentage of Participants With 100 Percent (%) Reduction in Inflammatory Lesions at Weeks 4, 8 and 12

    Weeks 4, 8 and 12

  • Clinician's Erythema Assessment (CEA) Total Score at Weeks 4, 8 and 12

    Weeks 4, 8 and 12

  • Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12

    Weeks 4, 8 and 12

  • +19 more secondary outcomes

Study Arms (2)

Ivermectin 1% cream + Doxycycline 40 mg MR capsules

EXPERIMENTAL
Drug: Ivermectin 1% creamDrug: Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules

Ivermectin 1% cream + Oral placebo capsules

PLACEBO COMPARATOR
Drug: Ivermectin 1% creamOther: Oral placebo capsules

Interventions

Ivermectin 1% creamDRUG

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

Ivermectin 1% cream + Doxycycline 40 mg MR capsulesIvermectin 1% cream + Oral placebo capsules
Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsulesDRUG

1 Capsule once-daily for 12 weeks

Ivermectin 1% cream + Doxycycline 40 mg MR capsules
Oral placebo capsulesOTHER

1 Capsule once-daily for 12 weeks

Ivermectin 1% cream + Oral placebo capsules

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Private Practice

Fort Smith, Arkansas, 72916, United States

Location

Private practice

Sacramento, California, 95819, United States

Location

Private practice

Boca Raton, Florida, 33486, United States

Location

Private practice

Louisville, Kentucky, 40202, United States

Location

Private practice

Louisville, Kentucky, 40241, United States

Location

Private Practice

Metairie, Louisiana, 70001, United States

Location

Private practice

Omaha, Nebraska, 68144, United States

Location

Private practice

Las Vegas, Nevada, 89148, United States

Location

Private practice

Pflugerville, Texas, 78660, United States

Location

Private practice

Markham, Canada

Location

Private practice

Montreal, Canada

Location

Private practice

Peterborough, Canada

Location

Private practice

Richmond Hill, Canada

Location

Private practice

Waterloo, Canada

Location

Private practice

Budapest, Hungary

Location

University

Debrecen, Hungary

Location

Hospital

Miskolc, Hungary

Location

Private practice

Pécel, Hungary

Location

University

Pécs, Hungary

Location

University

Szeged, Hungary

Location

Private practice

Szolnok, Hungary

Location

MeSH Terms

Conditions

Rosacea

Interventions

IvermectinDoxycyclineCapsules

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic ChemicalsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsDosage FormsPharmaceutical Preparations

Results Point of Contact

Title
Rajeev Chavda
Organization
Galderma
rajeev.chavda@galderma.com
0033492382928

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 9, 2017

Study Start

July 5, 2017

Primary Completion

February 8, 2018

Study Completion

February 8, 2018

Last Updated

March 16, 2021

Results First Posted

November 29, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

HU(7)CA(5)US(9)