Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea

• ClinicalTrials.gov Identifier: NCT03263273
• Recruitment Status: Completed
• First Posted: August 28, 2017
• Last Update Posted: November 8, 2019
• Sponsor: Hovione Scientia Limited
• Information provided by (Responsible Party): Hovione Scientia Limited

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Rosacea; Papulopustular Rosacea	Drug: 1% Topical Minocycline Gel; Drug: 3% Topical Minocycline Gel; Other: Topical Vehicle Gel	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 270 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: October 30, 2017
• Actual Primary Completion Date: March 1, 2019
• Actual Study Completion Date: July 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Topical Vehicle Gel; Topical administration of vehicle gel. Regimen: Apply once daily, at bedtime to the face	Other: Topical Vehicle Gel; Treating Papulopustular Rosacea while monitoring for safety and efficacy of the vehicle intervention; Other Name: HY01 Topical Gel, 0%
Active Comparator: 1% Topical Minocycline Gel; Topical administration of 1% Topical Minocycline Gel. Regimen: Apply once daily, at bedtime to the face	Drug: 1% Topical Minocycline Gel; Treating Papulopustular Rosacea while monitoring for safety and efficacy of the active intervention; Other Name: HY01 Topical Gel, 1%
Active Comparator: 3% Topical Minocycline Gel; Topical administration of 3% Topical Minocycline Gel. Regimen: Apply once daily, at bedtime to the face	Drug: 3% Topical Minocycline Gel; Treating Papulopustular Rosacea while monitoring for safety and efficacy of the active intervention; Other Name: HY01 Topical Gel, 3%

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Investigator's Global Assessment (IGA) Score [ Time Frame: 12 weeks ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).
• 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.

Contacts and Locations

Locations

United States, Arkansas

Clinical Site - 15

Bryant, Arkansas, United States, 72022

Clinical Site - 20

Rogers, Arkansas, United States, 72758

United States, California

Center for Dermatology Clinical Research, Inc.

Fremont, California, United States, 94538

Clinical Site - 19

Santa Monica, California, United States, 90404

United States, Florida

Clinical Site - 5

Tampa, Florida, United States, 33624

United States, Idaho

Clinical Site - 16

Boise, Idaho, United States, 83704

United States, Massachusetts

Clinical Site - 22

Boston, Massachusetts, United States, 02116

Clinical Site - 23

Watertown, Massachusetts, United States, 02472

United States, Michigan

Clinical Site - 14

Clinton Township, Michigan, United States, 48038

United States, Minnesota

Clinical Site - 6

Fridley, Minnesota, United States, 55432

United States, Nebraska

Clinical Site - 12

Omaha, Nebraska, United States, 68144

United States, New Jersey

Clinical Site - 21

Berlin, New Jersey, United States, 08009

United States, New York

Clinical Site - 13

New York, New York, United States, 10022

Clinical Site - 2

New York, New York, United States, 10155

United States, North Carolina

Clinical Site - 4

High Point, North Carolina, United States, 27262

United States, Oregon

Clinical Site - 17

Portland, Oregon, United States, 97210

United States, Pennsylvania

Clinical Site - 11

Fort Washington, Pennsylvania, United States, 19034

United States, Tennessee

Clinical Site - 8

Goodlettsville, Tennessee, United States, 37072

United States, Texas

Clinical Site - 7

Pflugerville, Texas, United States, 78660

Clinical Site - 18

San Antonio, Texas, United States, 78213

Clinical Site - 3

San Antonio, Texas, United States, 78229

Clinical Site - 9

San Antonio, Texas, United States, 78229

United States, Virginia

Clinical Site - 10

Norfolk, Virginia, United States, 23502

Sponsors and Collaborators

Hovione Scientia Limited

Investigators

• Principal Investigator: Sunil S Dhawan, MD; Center for Dermatology Clinical Research, Inc.

More Information

• Responsible Party: Hovione Scientia Limited
• ClinicalTrials.gov Identifier: NCT03263273
• Other Study ID Numbers: HY01-003
• First Posted: August 28, 2017
• Last Update Posted: November 8, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hovione Scientia Limited:

Minocycline; Topical; Tetracycline; Doxycycline; Rosacea; Skin Disease; Anti-Bacterial Agent; Anti-Inflammatory Agent

Additional relevant MeSH terms:

Rosacea; Skin Diseases; Minocycline; Anti-Bacterial Agents; Anti-Infective Agents