RosaceaPhase 2NCT03263273
Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea
A Phase 2 study testing 1% Topical Minocycline Gel and 3% Topical Minocycline Gel in people with Rosacea and Papulopustular Rosacea, run by Hovione Scientia Limited at 23 sites in United States.
Trial summary
To evaluate the efficacy of once-daily application of 1% and 3% HY01 Topical Gel, as assessed by the change in inflammatory lesion count from baseline over the 12-week treatment period in patients with moderate-to-severe papulopustular rosacea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea, Papulopustular Rosacea
- What is being tested?
- 1% Topical Minocycline Gel and 3% Topical Minocycline Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 23 sitesUnited States
- Study dates
- 30 Oct 2017to 1 Jul 2019
- Phase
- Phase 2
- 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
- Subjects who had provided written informed consent to participate in the study.
- Male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of moderate to severe facial rosacea, defined as the presence of: i. At least twelve and not more than forty inflammatory facial lesions (i.e., papules/pustules), AND ii. Subjects with a grade 3 or 4 on the 5-point Investigators Global Assessment (IGA) scale, AND iii. Persistent facial erythema (scored as at least mild on Erythema Severity Scale), AND iv. Facial telangiectasia (scored as at least mild on Telangiectasia Severity Scale.
- Subject willing to minimize external factors that might trigger rosacea flare-ups as recommended per protocol and patient instructional guide (e.g., spicy foods, thermally hot foods and drinks, hot environments, prolonged sun exposure, strong winds and alcoholic beverages).
- Non-nursing, female subjects of child bearing potential, who are using an acceptable form of birth control: total abstinence, oral (birth control pills), intravaginal: (e.g. NuvaRing®), implantable (e.g. Norplant®), injectable (e.g. Depo-Provera®) or transdermal (e.g. Ortho Evra®) contraception; intrauterine device (IUD); double-barrier (diaphragm or condom with spermicidal gel or foam); for two months prior to study enrollment or a vasectomized partner. All female subjects of child bearing potential must have undergone an in-office urine pregnancy test, with a negative result, prior to being randomized to receive study drug. In addition, women of childbearing potential must have agreed to a have urine pregnancy test at Day 42 and at the end of the study (Day 84). Females not of childbearing potential due to menopause must have been postmenopausal for at least one year. Male subjects must be willing to not attempt to conceive a child during the participation in the study. Females utilizing oral contraception must be willing to utilize an appropriate secondary form of contraception during the study.
- Subjects who use the same brand of soap, make-up, hair products, or shaving lotion/foam/cream/gel for a period of at least four weeks prior to the Baseline Visit and agree not to change these product brand/types during the study, with the exception of using the study approved cleanser and moisturizer with sunscreen provided by the sponsor.
- Male subjects who are willing to shave, if applicable, at approximately the same time every day.
- Subjects who are willing to refrain from sunbathing, using sun tanning booths/beds, or excessive exposure to the sun for the duration of the study.
Who cannot join
- Presence of any skin condition on the face that would interfere with the diagnosis or assessment of rosacea as determined by the Investigator.
- Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of rosacea. Patients also must not grow excess facial hair during the study (i.e. they need to be free of excess facial hair for follow-up visits).
- History of hypersensitivity or allergy to minocycline, any other tetracycline or any other component of the formulation, or known reactions to cleansers, including Ponds Cold Cream, and moisturizer with sunscreen.
- Subjects using, or planning use of concomitant treatments within 30 days prior to Baseline visit (e.g., facial or chemical peels, dermal fillers, acne surgery, intralesional steroids, spironolactone, debridement, cryotherapy, dermabrasion, X-ray, IPL, laser therapy or UV therapy).
- Use within 6 months prior to baseline of oral retinoids (e.g. isotretinoin, acitretin) or therapeutic vitamin A supplements of greater than 10,000 International Units/day (multivitamins are allowed).
- Subjects using estrogens or progestin agents (e.g., Gynogen, Valergen, Depo-Testadiol, Depogen, birth control pills), for less than 2 months prior to the Baseline Visit. (Subjects using estrogens for 2 months or more are not excluded unless the subject expected to change dose, drug, or discontinue estrogen use during the study).
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- Use within 2 month prior to the Baseline Visit of 1) topical retinoids to the face, 2) 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, metronidazole), or 3) systemic corticosteroids.
- Use within 2 months prior to the Baseline Visit of 1) topical corticosteroids, 2) topical antibiotics or 3) topical medications for rosacea (e.g., metronidazole, azelaic acid, erythromycin, ivermectin, sulfur based topical products).
- Subjects with rhinophyma, dense telangiectasia, or plaque-like facial edema, more than 5 nodules or sinus tracts.
- Ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
- Subjects with underlying diseases or other dermatological conditions, such as; atopic dermatitis, perioral dermatitis, or seborrheic dermatitis, which required the use of interfering topical or systemic therapy or may have interfered with the rosacea diagnosis.
- Subjects using an investigational drug or participating in an investigational study within 30 days of the Baseline Visit. Use of an investigational drug and/or participation in another investigational study prohibited during this study.
- Subjects who currently abuse alcohol or drugs or who have a history of chronic alcohol or drug abuse with in the past year.
- Medical history of immunodeficiency or other significant ongoing medical condition or disease as determined by the investigator.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Clinical Site - 21
Berlin, New Jersey, 08009
Clinical Site - 16
Boise, Idaho, 83704
Clinical Site - 22
Boston, Massachusetts, 02116
Clinical Site - 15
Bryant, Arkansas, 72022
Clinical Site - 14
Clinton Township, Michigan, 48038
Clinical Site - 11
Fort Washington, Pennsylvania, 19034
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
Clinical Site - 6
Fridley, Minnesota, 55432
Clinical Site - 8
Goodlettsville, Tennessee, 37072
Clinical Site - 4
High Point, North Carolina, 27262
Clinical Site - 13
New York, New York, 10022
Clinical Site - 2
New York, New York, 10155
Clinical Site - 10
Norfolk, Virginia, 23502
Clinical Site - 12
Omaha, Nebraska, 68144
Clinical Site - 7
Pflugerville, Texas, 78660
Clinical Site - 17
Portland, Oregon, 97210
Clinical Site - 20
Rogers, Arkansas, 72758
Clinical Site - 18
San Antonio, Texas, 78213
Clinical Site - 3
San Antonio, Texas, 78229
Clinical Site - 9
San Antonio, Texas, 78229
Clinical Site - 19
Santa Monica, California, 90404
Clinical Site - 5
Tampa, Florida, 33624
Clinical Site - 23
Watertown, Massachusetts, 02472
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel Group, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 1% and 3% Topical MIinocycline Gel (HY01) in Patients With Papulopustular Rosacea
To evaluate the efficacy of once-daily application of 1% and 3% HY01 Topical Gel, as assessed by the change in inflammatory lesion count from baseline over the 12-week treatment period in patients with moderate-to-severe papulopustular rosacea.
- Conditions
- Rosacea, Papulopustular Rosacea
- Being tested
- 1% Topical Minocycline Gel, 3% Topical Minocycline Gel, Topical Vehicle Gel
- Keywords
- Minocycline, Topical, Tetracycline, Doxycycline, Rosacea, Skin Disease, Anti-Bacterial Agent, Anti-Inflammatory Agent
- Medical subject headings
- Rosacea, cyclopia sequence, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Topical Minocycline GelDrug
Also called HY01 Topical Gel, 1%
Treating Papulopustular Rosacea while monitoring for safety and efficacy of the active intervention
3% Topical Minocycline GelDrug
Also called HY01 Topical Gel, 3%
Treating Papulopustular Rosacea while monitoring for safety and efficacy of the active intervention
Topical Vehicle GelOther
Also called HY01 Topical Gel, 0%
Treating Papulopustular Rosacea while monitoring for safety and efficacy of the vehicle intervention
| Study group | Role | What they receive |
|---|---|---|
| Topical Vehicle Gel | Placebo comparator | Topical administration of vehicle gel. Regimen: Apply once daily, at bedtime to the face Receives: Other: Topical Vehicle Gel |
| 1% Topical Minocycline Gel | Active comparator | Topical administration of 1% Topical Minocycline Gel. Regimen: Apply once daily, at bedtime to the face Receives: Drug: 1% Topical Minocycline Gel |
| 3% Topical Minocycline Gel | Active comparator | Topical administration of 3% Topical Minocycline Gel. Regimen: Apply once daily, at bedtime to the face Receives: Drug: 3% Topical Minocycline Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lesion Count
Evaluate the efficacy of once-daily application of 1% and 3% HY01 Topical Gel, as assessed by the change in inflammatory lesion count from baseline in patients with moderate-to-severe papulopustular rosacea
Measured: 12 weeks
Secondary outcomes (1)
Investigator's Global Assessment (IGA) Score
Evaluate the efficacy of once-daily application of 1% and 3% HY01 Topical Gel, in improving the Investigator's Global Assessment (IGA) scores from baseline over the 12-week treatment period in patients with moderate-to-severe papulopustular rosacea as defined as either a 2 point improvement from baseline or an improvement to "clear" or "almost clear" on the IGA
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start30 Oct 2017
- Primary completion1 Mar 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hovione Scientia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sunil S Dhawan, MD, Principal investigator, Center for Dermatology Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263273
- Sponsor's protocol ID
- HY01-003
- Status last verified
- Nov 2019
- First submitted
- 24 Aug 2017
- Last updated
- 8 Nov 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel Group, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 1% and 3% Topical MIinocycline Gel (HY01) in Patients With Papulopustular Rosacea
- ClinicalTrials.gov ID
- NCT03263273
- Acronym / sponsor ID
- HY01-003
- Conditions
- Rosacea, Papulopustular Rosacea
- Keywords
- Minocycline, Topical, Tetracycline, Doxycycline, Rosacea, Skin Disease, Anti-Bacterial Agent, Anti-Inflammatory Agent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Hovione Scientia LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 28 Aug 2017 (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 evaluate the efficacy of once-daily application of 1% and 3% HY01 Topical Gel, as assessed by the change in inflammatory lesion count from baseline over the 12-week treatment period in patients with moderate-to-severe papulopustular 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 |
|---|---|---|
| Topical Vehicle Gel | Placebo comparator | Other: Topical Vehicle GelTopical administration of vehicle gel. Regimen: Apply once daily, at bedtime to the face |
| 1% Topical Minocycline Gel | Active comparator | Drug: 1% Topical Minocycline GelTopical administration of 1% Topical Minocycline Gel. Regimen: Apply once daily, at bedtime to the face |
| 3% Topical Minocycline Gel | Active comparator | Drug: 3% Topical Minocycline GelTopical administration of 3% Topical Minocycline Gel. Regimen: Apply once daily, at bedtime to the face |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who had provided written informed consent to participate in the study.
- Male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of moderate to severe facial rosacea, defined as the presence of: i. At least twelve and not more than forty inflammatory facial lesions (i.e., papules/pustules), AND ii. Subjects with a grade 3 or 4 on the 5-point Investigators Global Assessment (IGA) scale, AND iii. Persistent facial erythema (scored as at least mild on Erythema Severity Scale), AND iv. Facial telangiectasia (scored as at least mild on Telangiectasia Severity Scale.
- Subject willing to minimize external factors that might trigger rosacea flare-ups as recommended per protocol and patient instructional guide (e.g., spicy foods, thermally hot foods and drinks, hot environments, prolonged sun exposure, strong winds and alcoholic beverages).
- Non-nursing, female subjects of child bearing potential, who are using an acceptable form of birth control: total abstinence, oral (birth control pills), intravaginal: (e.g. NuvaRing®), implantable (e.g. Norplant®), injectable (e.g. Depo-Provera®) or transdermal (e.g. Ortho Evra®) contraception; intrauterine device (IUD); double-barrier (diaphragm or condom with spermicidal gel or foam); for two months prior to study enrollment or a vasectomized partner. All female subjects of child bearing potential must have undergone an in-office urine pregnancy test, with a negative result, prior to being randomized to receive study drug. In addition, women of childbearing potential must have agreed to a have urine pregnancy test at Day 42 and at the end of the study (Day 84). Females not of childbearing potential due to menopause must have been postmenopausal for at least one year. Male subjects must be willing to not attempt to conceive a child during the participation in the study. Females utilizing oral contraception must be willing to utilize an appropriate secondary form of contraception during the study.
- Subjects who use the same brand of soap, make-up, hair products, or shaving lotion/foam/cream/gel for a period of at least four weeks prior to the Baseline Visit and agree not to change these product brand/types during the study, with the exception of using the study approved cleanser and moisturizer with sunscreen provided by the sponsor.
Key exclusion criteria (14 listed)
- Presence of any skin condition on the face that would interfere with the diagnosis or assessment of rosacea as determined by the Investigator.
- Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of rosacea. Patients also must not grow excess facial hair during the study (i.e. they need to be free of excess facial hair for follow-up visits).
- History of hypersensitivity or allergy to minocycline, any other tetracycline or any other component of the formulation, or known reactions to cleansers, including Ponds Cold Cream, and moisturizer with sunscreen.
- Subjects using, or planning use of concomitant treatments within 30 days prior to Baseline visit (e.g., facial or chemical peels, dermal fillers, acne surgery, intralesional steroids, spironolactone, debridement, cryotherapy, dermabrasion, X-ray, IPL, laser therapy or UV therapy).
- Use within 6 months prior to baseline of oral retinoids (e.g. isotretinoin, acitretin) or therapeutic vitamin A supplements of greater than 10,000 International Units/day (multivitamins are allowed).
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 |
|---|---|---|
| 1% Topical Minocycline GelAlso: HY01 Topical Gel, 1%Treating Papulopustular Rosacea while monitoring for safety and efficacy of the active intervention | Drug | 1% Topical Minocycline Gel |
| 3% Topical Minocycline GelAlso: HY01 Topical Gel, 3%Treating Papulopustular Rosacea while monitoring for safety and efficacy of the active intervention | Drug | 3% Topical Minocycline Gel |
| Topical Vehicle GelAlso: HY01 Topical Gel, 0%Treating Papulopustular Rosacea while monitoring for safety and efficacy of the vehicle intervention | Other | Topical Vehicle Gel |
Primary outcome
Change in Lesion Count
Time frame: 12 weeks
Evaluate the efficacy of once-daily application of 1% and 3% HY01 Topical Gel, as assessed by the change in inflammatory lesion count from baseline in patients with moderate-to-severe papulopustular rosacea
1 secondary outcome
Investigator's Global Assessment (IGA) Score
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 8 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Sunil S Dhawan, MD principal investigator
Center for Dermatology Clinical Research, Inc.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1% Topical Minocycline Gel and 3% Topical Minocycline Gel in people with Rosacea and Papulopustular Rosacea, run by Hovione Scientia Limited at 23 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 7 inclusion and 14 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 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in Lesion Count (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2019.