Facial RosaceaPhase 3NCT04106726

Bioequivalence Study of Ivermectin Cream 1% in Treatment of Moderate to Severe Facial Rosacea

A Phase 3 study testing Soolantra® Ivermectin cream 1% and Ivermectin cream 1% in people with Facial Rosacea, run by Zydus Worldwide DMCC at 11 sites in United States.

Completed

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

Official record

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Trial summary

To evaluate the therapeutic equivalence and safety of ivermectin cream 1% (Zydus Worldwide DMCC) and Soolantra® (ivermectin) cream, 1% (Galderma Laboratories, L.P.) in the treatment of moderate to severe facial papulopustular rosacea. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Facial Rosacea
What is being tested?: Soolantra® Ivermectin cream 1% and Ivermectin cream 1%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 525 participants
Where: 11 sitesUnited States
Study dates: 17 Oct 2019to 4 Aug 2020
Phase: Phase 3
Are there results?: None posted in the registry

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

Healthy male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of facial papulopustular rosacea.
Subjects must have provided IRB approved written informed consent.
Subjects must have at least 15 and not more than 50 inflammatory facial lesions (i.e., papules/pustules) at screening and baseline visits. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area including those present on the nose. Lesions involving the eyes, and scalp will be excluded from the count.
Subjects must have no more than 2 nodulocystic lesions on the face at Screening and Baseline visits.
Subjects must have a definite clinical diagnosis of facial papulopustular rosacea severity grade 3 or 4 as per the Investigator Global Assessment (IGA) (per Table 1 below) at screening and baseline visits.
Subjects must have persistent erythema on the face with moderate (2) score or higher (per table 2 below) at screening and baseline visits.

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Subjects must have a mild (1) to moderate (2) score for telangiectasia on the face. (per table 3 below) at screening and baseline visits.
8. Subjects must be willing to minimize external factors that might trigger rosacea flare-ups (e.g., spicy foods, thermally hot foods and drinks, hot environments, prolonged sun exposure, strong winds and alcoholic beverages)
Subjects must be willing to refrain from using all other topical medications for rosacea during the 12-week treatment period, other than the investigational product.
Female Subjects of childbearing potential (excluding women who are or premenarchal, surgically sterilized (by hysterectomy) or postmenopausal for at least 1 year prior to screening), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug. For the purpose of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, Depo-Provera® (stabilized for at least 3 months prior to screening), NuvaRing® (vaginal contraceptive), Implanon™ (contraceptive implant), double-barrier methods (e.g. condom and spermicide), IUD, or abstinence with a 2nd acceptable method of birth control should the Subject become sexually active. Subjects on hormonal contraception must be stabilized on the same type for at least three months prior to screening and must not change the method during the study. A sterile sexual partner is NOT considered an adequate form of birth control.
All male Subjects must agree to use accepted methods of birth control with their partners, from the day of the first dose administration to 30 days after the last administration of study drug. Abstinence is an acceptable method of birth control. Female partners should use an acceptable method of birth control as described in the above Item Number 10.
Subjects who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to screening and must agree to not change make-up brand/type or frequency of use throughout the study.
Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
Subjects must be in good health and free from any clinically significant disease, including but not limited to, conditions that may interfere with the evaluation of facial rosacea. Such conditions include but are not limited to the following: autoimmune disease; acne vulgaris on the face; seborrheic dermatitis on the face; perioral dermatitis; corticosteroid-induced acne; carcinoid syndrome; mastocytosis; acneiform eruptions caused by make-up, medication, facial psoriasis and facial eczema.

Who cannot join

Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
Subjects with a history of hypersensitivity or allergy to ivermectin, propylene glycol and/or any of the study medication ingredients and its excipients.
Subjects with the presence of other forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other dermatoses that may be confounded with papulopustular rosacea, such as peri-oral dermatitis, facial keratosis pilaris, seborrheic dermatitis and acne.
Subjects with excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of facial rosacea.
Subjects with moderate or severe rhinophyma, dense telangiectases (score 3, severe), or plaque-like facial edema.
Subjects with a severe irritation (score 3 = severe (marked/intense)) for dryness, pruritus, or stinging/burning.

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Subjects with ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
Subjects who currently have or have recently had bacterial folliculitis on the face.
Subjects who have unstable medical disorders that are clinically significant or have lifethreatening diseases. Subjects who have clinically significant abnormal laboratory values according to the investigator at screening.
Subjects who had within 14 days prior to screening:
wax depilation of the face
cosmetic procedures (e.g., facials) which may affect assessment of facial rosacea
exposure to excessive UV radiation or the subject is planning exposure during the study (e.g. occupational exposure to the sun, planned holidays in the sun during the study, phototherapy, tanning salon),
used a sauna.
Subjects who have used any of the following procedures on the face within 1 month prior to screening:
cryodestruction or chemodestruction,
dermabrasion,
photodynamic therapy,
acne surgery,
intralesional steroids, or
X-ray therapy.
Subjects who have used any of the following topical treatments on the face within 1 month prior to screening:
retinoids
benzoyl peroxide
immunomodulators
antibiotics (e.g., metronidazole and macrolides)
corticosteroids
other topical rosacea treatment (e.g., azelaic acid, metronidazole) or topical erythema treatment (e.g. brimonidine)
Subjects who have used any of the following systemic treatments within 1 month prior to screening:
corticosteroids,
systemic 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),
other systemic treatments that affect erythema: alpha-blockers (e.g., mirtazapine), beta-blockers (e.g., propranolol), alpha 2 agonist (e.g., clonidine), or
other systemic treatment for rosacea.
Subjects who have used any of the following topical treatments within 6 weeks prior to screening:
corticosteroids,
antibiotics for rosacea,
medications for rosacea (e.g., azelaic acid, metronidazole),
over-the-counter preparations for rosacea, or
anti-inflammatory agents. Note: Non-steroidal anti-inflammatory drugs (NSAIDs) and aspirin use on an as needed basis and if not used consecutively for > 14 days prior to screening and/or during the study is acceptable. Note: Low dose (81 mg) aspirin taken daily is acceptable.
Subjects who have used or changed their use of estrogens or oral contraceptives within the 3 months prior to screening.
Subjects who have received radiation therapy and/or anti-neoplastic agents within 3 months prior to screening.
Subjects who have used within 6 months prior to screening antiandrogens such as Spironolactone, oral retinoids (e.g. Accutane®), or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
Subjects who have had laser therapy (for telangiectasia or other conditions), electrodessication and phototherapy (e.g., ClearLight®) to the facial area within 6 months prior to study entry (Visit 1 Screening Visit).
Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids, cocaine and barbiturates).
Subjects who have participated in an investigational drug study (i.e., Subjects have been treated with an investigational drug) within 30 days prior to screening will be excluded from study participation. Subjects who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion.
Subjects who have been previously enrolled in this study.
Subjects who live in the same household with subjects currently enrolled in this trial.
Subjects who have a history of being unresponsive to topical ivermectin therapy.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Zydus Worldwide DMCC
Brandon, Florida, 33511
Zydus Worldwide DMCC
El Paso, Texas, 79902
Zydus Worldwide DMCC
El Paso, Texas, 79925
Zydus Worldwide DMCC
Fort Lauderdale, Florida, 33308
Zydus Worldwide DMCC
High Point, North Carolina, 27262
Zydus Worldwide DMCC
Miami, Florida, 33175
Zydus Worldwide DMCC
Miramar, Florida, 33027
Zydus Worldwide DMCC
Saginaw, Michigan, 48604
Zydus Worldwide DMCC
Sugarloaf, Pennsylvania, 18249
Zydus Worldwide DMCC
Tampa, Florida, 33609
Zydus Worldwide DMCC
Upper Saint Clair, Pennsylvania, 15241

Other trials in United States

About this study

Official title: A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY, COMPARING IVERMECTIN CREAM 1% (ZYDUS WORLDWIDE DMCC) TO SOOLANTRA® (GALDERMA LABORATORIES, L.P.) AND BOTH ACTIVE TREATMENTS TO A PLACEBO CONTROL IN THE TREATMENT OF MODERATE TO SEVERE FACIAL ROSACEA

To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of moderate to severe facial rosacea.

Conditions: Facial Rosacea
Being tested: Soolantra® Ivermectin cream 1%, Ivermectin cream 1%, Placebo for Ivermectin cream 1%
Keywords: Ivermectin

What participants receive

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

Soolantra® Ivermectin cream 1%Drug
Apply topically to the face once daily for 84 consecutive days.
Ivermectin cream 1%Drug
Apply topically to the face once daily for 84 consecutive days.
Placebo for Ivermectin cream 1%Drug
Apply topically to the face once daily for 84 consecutive days.

Study groups in NCT04106726
Study group	Role	What they receive
Test: Ivermectin cream 1%	Experimental	Manufactured by Zydus Worldwide DMCC; Apply cream to the affected areas of the face once daily for 12 weeks. Receives: Drug: Ivermectin cream 1%
Reference: Soolantra® cream, 1%	Active comparator	Manufactured by Galderma Laboratories, L.P.; Apply cream to the affected areas of the face once daily for 12 weeks. Receives: Drug: Soolantra® Ivermectin cream 1%
Placebo: Placebo for Ivermectin cream 1%	Placebo comparator	Manufactured by Zydus Worldwide DMCC; Apply to the affected areas of the face once daily for 12 weeks. Receives: Drug: Placebo for Ivermectin cream 1%

What is being measured

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

Mean percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts.
Mean percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts.
Measured: 12 weeks

Secondary outcomes (1)

Exploratory Endpoint: The proportion of subjects with a clinical response (IGA) of "success" at week 12.
The proportion of subjects with a clinical response (IGA) of "success" at week 12.
Measured: 12 weeks

Timeline

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

17 Oct 20194 Aug 2020

First posted27 Sep 2019
Study start17 Oct 2019
Primary completion4 Aug 2020
Study completion4 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Facial 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: 525 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04106726
Sponsor's protocol ID: IVRC 1907
Status last verified: Oct 2020
First submitted: 25 Sep 2019
Last updated: 14 Oct 2020
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy and Safety of Topical Clascoterone (WINLEVI) Cream 1% in Patients With Facial Acneiform Rosacea
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All Facial Rosacea trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY, COMPARING IVERMECTIN CREAM 1% (ZYDUS WORLDWIDE DMCC) TO SOOLANTRA® (GALDERMA LABORATORIES, L.P.) AND BOTH ACTIVE TREATMENTS TO A PLACEBO CONTROL IN THE TREATMENT OF MODERATE TO SEVERE FACIAL ROSACEA
ClinicalTrials.gov ID: NCT04106726
Acronym / sponsor ID: IVRC 1907
Conditions: Facial Rosacea
Keywords: Ivermectin
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 525 participants (actual)
Lead sponsor: Zydus Worldwide DMCCIndustry (pharma, biotech, devices)
Collaborators: Catawba Research, LLC
Study start: 17 Oct 2019 (actual)
Primary completion: 4 Aug 2020 (actual)
Study completion: 4 Aug 2020 (actual)
First posted: 27 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

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

To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of moderate to severe facial rosacea.

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
Test: Ivermectin cream 1%	Experimental	Drug: Ivermectin cream 1%Manufactured by Zydus Worldwide DMCC; Apply cream to the affected areas of the face once daily for 12 weeks.
Reference: Soolantra® cream, 1%	Active comparator	Drug: Soolantra® Ivermectin cream 1%Manufactured by Galderma Laboratories, L.P.; Apply cream to the affected areas of the face once daily for 12 weeks.
Placebo: Placebo for Ivermectin cream 1%	Placebo comparator	Drug: Placebo for Ivermectin cream 1%Manufactured by Zydus Worldwide DMCC; Apply to the affected areas of the face once daily for 12 weeks.

Who may qualify

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

Key inclusion criteria (14 listed)

Healthy male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of facial papulopustular rosacea.
Subjects must have provided IRB approved written informed consent.
Subjects must have at least 15 and not more than 50 inflammatory facial lesions (i.e., papules/pustules) at screening and baseline visits. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area including those present on the nose. Lesions involving the eyes, and scalp will be excluded from the count.
Subjects must have no more than 2 nodulocystic lesions on the face at Screening and Baseline visits.
Subjects must have a definite clinical diagnosis of facial papulopustular rosacea severity grade 3 or 4 as per the Investigator Global Assessment (IGA) (per Table 1 below) at screening and baseline visits.

Key exclusion criteria (49 listed)

Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
Subjects with a history of hypersensitivity or allergy to ivermectin, propylene glycol and/or any of the study medication ingredients and its excipients.
Subjects with the presence of other forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other dermatoses that may be confounded with papulopustular rosacea, such as peri-oral dermatitis, facial keratosis pilaris, seborrheic dermatitis and acne.
Subjects with excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of facial rosacea.
Subjects with moderate or severe rhinophyma, dense telangiectases (score 3, severe), or plaque-like facial edema.

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
Soolantra® Ivermectin cream 1%Apply topically to the face once daily for 84 consecutive days.	Drug	Reference: Soolantra® cream, 1%
Ivermectin cream 1%Apply topically to the face once daily for 84 consecutive days.	Drug	Test: Ivermectin cream 1%
Placebo for Ivermectin cream 1%Apply topically to the face once daily for 84 consecutive days.	Drug	Placebo: Placebo for Ivermectin cream 1%

Primary outcome

Mean percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts.
Time frame: 12 weeks
Mean percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts.

1 secondary outcome

Exploratory Endpoint: The proportion of subjects with a clinical response (IGA) of "success" at week 12.
Time frame: 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
Individual participant dataSharing planned: No

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Rosacea Radiofrequency Microneedling
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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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Soolantra® Ivermectin cream 1% and Ivermectin cream 1% in people with Facial Rosacea, run by Zydus Worldwide DMCC at 11 sites 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 14 inclusion and 49 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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Mean percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts. (time frame: 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 NCT04106726.

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 14 Oct 2020.