Moderate to Severe Papulopustular RosaceaPhase 3NCT02840461

Clinical Endpoint Study of Ivermectin 1% Cream

A Phase 3 study testing Ivermectin Cream, 1% in people with Moderate to Severe Papulopustular Rosacea, run by Actavis Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

A randomized, double-blind, placebo-controlled, parallel-design, multiple-site clinical study to evaluate the therapeutic equivalence and safety of ivermectin cream 1% (Actavis Laboratories UT, Inc.) to SoolantraTM (ivermectin) cream 1% (Galderma) in the treatment of moderate to severe papulopustular rosacea. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Moderate to Severe Papulopustular Rosacea
What is being tested?: Ivermectin Cream, 1%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 630 participants
Where: 1 siteUnited States
Study dates: Jun 2016to Dec 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed Informed Consent that meets all criteria of current FDA regulations.
Healthy male or non-pregnant, non-lactating female greater than or equal to 8 years of age with a clinical diagnosis of moderate to severe papulopustular rosacea, defined as the presence of:
A total of 8 to 50 combined papules/pustules on the face, AND At least moderate erythema, AND Telangiectasia
Patient has a baseline Investigator's Global Evaluation (IGE) score of 3 (moderate) or 4 (severe) for rosacea severity (See Appendix A).
Females of child bearing potential must not be pregnant or lactating at Screening (as confirmed by a negative urine pregnancy test with a sensitivity of less than 25 mlU/mL or equivalent units of human chorionic gonadotropin). Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, IUD, a double-barrier method [such as condom plus diaphragm with spermicide], oral, transdermal, injected or implanted non- or hormonal contraceptive), throughout the study. If the female is using a hormonal contraceptive, the same product must be taken for 3 months prior to Visit 1 and must agree not to replace with some other hormonal contraceptives during the study. A sterile sexual partner is not considered an adequate form of birth control.
All females will be considered to be of childbearing potential unless they: Are post-menopausal, defined as women who have been amenorrheic for at least 12 consecutive months, without other known or suspected primary cause.

Show all 13Show fewer

Have been sterilized surgically or who are otherwise proven sterile (i.e., total hysterectomy, or bilateral oophorectomy) with surgery at least 4 weeks before Screening. Tubal ligation will not be considered a surgically sterile method.
Female patients of childbearing potential are defined as Women without prior hysterectomy of at least 4 weeks, or who have had any evidence of menses in the past 12 months.
Females who have been amenorrhea for more than or equal to 12 months, but the amenorrhea is possibly due to other causes, including prior chemotherapy, anti-estrogens, or ovarian suppression.
Free from any systemic or dermatologic disorder that, in the opinion of the Investigator, will interfere with the study results or increase the risk of adverse events.
Willing to minimize external factors that might trigger rosacea flare-ups (e.g., extreme temperatures, aggressive astringents, known offending foods such as spicy foods and thermally hot foods and drinks, prolonged sun exposure, strong winds, alcoholic beverages, and emotional stress) within 24 hours before the Screening visit.
Of any skin type or race, provided the skin pigmentation allows accurate evaluation of papulopustular rosacea.
Willingness and capability to cooperate to the extent and degree required by the protocol.

Who cannot join

Females who are pregnant, lactating or planning to become pregnant during the study period.
Patient has mild facial rosacea (less than 8 inflammatory lesions on the face) or very severe rosacea (more than 50 inflammatory lesions).
Patient has mild erythema.
Patient has a baseline IGE score of 0, 1 or 2.
Patient has a skin condition on the face that would interfere with the diagnosis or assessment of rosacea (e.g., dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, bacterial folliculitis).
Patients with excessive facial hair, such as beards, sideburns, moustaches, etc., that would interfere with diagnosis or assessment of rosacea.

Show all 25Show fewer

Patients with tattoos or excessive facial scarring that, in the Investigator's opinion, may interfere with the evaluation of the patient's rosacea.
Patients with active facial sunburn, peeling from sunburn, or patients that will be exposed to excessive sunlight during the study.
Patient has significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation.
Any patient (male or female) who has started, or changed hormonal therapy within 3 months of the baseline visit (this includes hormonal contraceptives). Patients who have been on stable hormone therapy for at least 3 months and whose therapy is considered unlikely to be changed for the duration of the study will be eligible.
History of hypersensitivity or allergy to study drug, or other ingredients of the formulation.
Use within 6 months prior to baseline of oral retinoids (e.g., Accutane) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
Use for less than 3 months prior to baseline of estrogen- and/or progestin-containing oral, injectable, implant, or transdermal contraceptives; use of such therapy must remain constant throughout the study.
Use within 1 month prior to baseline of 1) topical retinoids to the face, 2) systemic (e.g., oral or injectable) antibiotics known to have an impact on the severity of facial rosacea (e.g., containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim), 3) systemic steroids, 4) photodynamic therapy (including laser and other light therapies), or 6) cosmetic procedures (e.g., superficial chemical peels, exfoliation or microdermabrasion of the face).
Use within 2 weeks prior to baseline of 1) topical corticosteroids, 2) topical antibiotics, 3) topical anti-inflammatory agents or 4) topical medications for rosacea (e.g., metronidazole, azelaic acid, sodium sulfacetamide, ivermectin) 5) immunosuppressive drugs, 6) anticoagulant therapy.
Use of any other topical products applied to the target site.
Use of systemic corticosteroids. The use of inhaled corticosteroids up to less than 1mg per day is acceptable.
Use of antipruritics, including antihistamines, within 24 hours of study visits.
Patients who use make-up must have used the same brands/types for a minimum period of 14 days before study entry and must agree to not change brand or frequency of use throughout the study.
Presence of carcinoid, pheochromocytoma, or other causes of systemic flushing.
Presence of acne conglobata, acne fulminans, secondary acne or severe acne requiring systemic treatment.
Ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
Receipt of any drug as part of a research study within 30 days before dosing.
Employees of the research center or Investigator.
Patients who are illiterate

Trial locations and contacts

1 site in 1 country.

United States1 site

Investigator site 1
Arlington Heights, Illinois, 60005

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence and Safety of Ivermectin Cream 1% (Actavis Laboratories UT, Inc.) to SoolantraTM (Ivermectin) Cream 1% (Galderma) in the Treatment of Moderate to Severe Papulopustular Rosacea

Conditions: Moderate to Severe Papulopustular Rosacea
Being tested: Ivermectin Cream, 1%, Placebo/Vehicle cream

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ivermectin Cream, 1%Drug
Placebo/Vehicle creamDrug

Study groups in NCT02840461
Study group	Role	What they receive
Ivermectin Cream, 1%	Experimental	test product, manufactured by Actavis Laboratories UT, Inc. Receives: Drug: Ivermectin Cream, 1%
SoolantraTM (ivermectin) Cream, 1%	Active comparator	reference product, manufactured by Galderma Laboratories, L.P. Receives: Drug: Ivermectin Cream, 1%
Placebo/Vehicle cream	Placebo comparator	Placebo, manufactured by Actavis Laboratories UT, Inc. Receives: Drug: Placebo/Vehicle cream

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline to Week 12 in the Number of Inflamed (Papules/Pustules) Lesions of Rosacea.
Bioequivalence of the test to reference was considered to have been demonstrated if the 90% confidence interval for the test to reference ratio for the percent change from baseline to Week 12 in the number of inflamed lesion counts was within [80%, 125%].
Measured: Baseline and 12 Weeks

Secondary outcomes (1)

The Percentage of Patients With a Clinical Response of "Success".
The secondary endpoint was the percentage of patients with a clinical response of "success" using the IGE at Week 12. At Visit 1, the IGE had to be 3 or 4 for the patient to be eligible for inclusion.
Measured: Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Dec 2016

First posted21 Jul 2016 (estimated)
Study startJun 2016
Primary completionNov 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Moderate to Severe Papulopustular RosaceaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 630 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02840461
Sponsor's protocol ID: 71591701
Status last verified: May 2020
First submitted: 19 Jul 2016
Last updated: 2 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence and Safety of Ivermectin Cream 1% (Actavis Laboratories UT, Inc.) to SoolantraTM (Ivermectin) Cream 1% (Galderma) in the Treatment of Moderate to Severe Papulopustular Rosacea
ClinicalTrials.gov ID: NCT02840461
Acronym / sponsor ID: 71591701
Conditions: Moderate to Severe Papulopustular Rosacea
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 630 participants (actual)
Lead sponsor: Actavis Inc.Industry (pharma, biotech, devices)
Study start: Jun 2016 (actual)
Primary completion: Nov 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 21 Jul 2016 (estimated)
Results: Posted 2 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Ivermectin Cream, 1%	Experimental	Drug: Ivermectin Cream, 1%test product, manufactured by Actavis Laboratories UT, Inc.
SoolantraTM (ivermectin) Cream, 1%	Active comparator	Drug: Ivermectin Cream, 1%reference product, manufactured by Galderma Laboratories, L.P.
Placebo/Vehicle cream	Placebo comparator	Drug: Placebo/Vehicle creamPlacebo, manufactured by Actavis Laboratories UT, Inc.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Signed Informed Consent that meets all criteria of current FDA regulations.
Healthy male or non-pregnant, non-lactating female greater than or equal to 8 years of age with a clinical diagnosis of moderate to severe papulopustular rosacea, defined as the presence of:
A total of 8 to 50 combined papules/pustules on the face, AND At least moderate erythema, AND Telangiectasia
Patient has a baseline Investigator's Global Evaluation (IGE) score of 3 (moderate) or 4 (severe) for rosacea severity (See Appendix A).
Females of child bearing potential must not be pregnant or lactating at Screening (as confirmed by a negative urine pregnancy test with a sensitivity of less than 25 mlU/mL or equivalent units of human chorionic gonadotropin). Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, IUD, a double-barrier method [such as condom plus diaphragm with spermicide], oral, transdermal, injected or implanted non- or hormonal contraceptive), throughout the study. If the female is using a hormonal contraceptive, the same product must be taken for 3 months prior to Visit 1 and must agree not to replace with some other hormonal contraceptives during the study. A sterile sexual partner is not considered an adequate form of birth control.

Key exclusion criteria (25 listed)

Females who are pregnant, lactating or planning to become pregnant during the study period.
Patient has mild facial rosacea (less than 8 inflammatory lesions on the face) or very severe rosacea (more than 50 inflammatory lesions).
Patient has mild erythema.
Patient has a baseline IGE score of 0, 1 or 2.
Patient has a skin condition on the face that would interfere with the diagnosis or assessment of rosacea (e.g., dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, bacterial folliculitis).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ivermectin Cream, 1%	Drug	Ivermectin Cream, 1%, SoolantraTM (ivermectin) Cream, 1%
Placebo/Vehicle cream	Drug	Placebo/Vehicle cream

Primary outcome

Percent Change From Baseline to Week 12 in the Number of Inflamed (Papules/Pustules) Lesions of Rosacea.
Time frame: Baseline and 12 Weeks
Bioequivalence of the test to reference was considered to have been demonstrated if the 90% confidence interval for the test to reference ratio for the percent change from baseline to Week 12 in the number of inflamed lesion counts was within [80%, 125%].

1 secondary outcome

The Percentage of Patients With a Clinical Response of "Success".
Time frame: Baseline to Week 12

Results and safety

Results posted to the registry on 2 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ivermectin Cream, 1%	259	236
SoolantraTM (Ivermectin) Cream, 1%	257	235
Placebo/Vehicle Cream	114	100

Primary outcome: Percent Change From Baseline to Week 12 in the Number of Inflamed (Papules/Pustules) Lesions of Rosacea.

Time frame: Baseline and 12 Weeks. Least squares mean (Standard Error). Unit: percentage of change from baseline

Measure	Ivermectin Cream, 1% n = 251	SoolantraTM (Ivermectin) Cream, 1% n = 248	Vehicle Cream n = 111
Value	-64.87 (2.03)	-64.87 (2.03)	-55.04 (2.92)

Ivermectin Cream, 1% vs SoolantraTM (Ivermectin) Cream, 1%: Mean Difference (Net): 103.51 (90% CI 97.95 to 110.00)
Ivermectin Cream, 1% vs Vehicle Cream: Mean Difference (Net): -9.83 (95% CI -16.24 to -3.42), p = 0.0027, ANOVA
SoolantraTM (Ivermectin) Cream, 1% vs Vehicle Cream: Mean Difference (Net): -9.83 (95% CI -16.25 to -3.40), p = 0.0028, ANOVA

Population analysed: Modified Intent-to-Treat Population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ivermectin Cream, 1%	0 of 259 (0%)	18 of 259 (6.9%)	0 of 259
SoolantraTM (Ivermectin) Cream, 1%	0 of 257 (0%)	24 of 257 (9.3%)	0 of 257
Placebo/Vehicle Cream	0 of 114 (0%)	14 of 114 (12.3%)	0 of 114

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ivermectin Cream, 1% in people with Moderate to Severe Papulopustular Rosacea, run by Actavis Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline to Week 12 in the Number of Inflamed (Papules/Pustules) Lesions of Rosacea. (time frame: Baseline and 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02840461.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.