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Trial record 2 of 2 for:    hovione

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03263273
Recruitment Status : Completed
First Posted : August 28, 2017
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Hovione Scientia Limited

Tracking Information
First Submitted Date  ICMJE August 24, 2017
First Posted Date  ICMJE August 28, 2017
Last Update Posted Date November 8, 2019
Actual Study Start Date  ICMJE October 30, 2017
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Rosacea
  • Papulopustular Rosacea
Intervention  ICMJE
  • Drug: 1% Topical Minocycline Gel
    Treating Papulopustular Rosacea while monitoring for safety and efficacy of the active intervention
    Other Name: HY01 Topical Gel, 1%
  • Drug: 3% Topical Minocycline Gel
    Treating Papulopustular Rosacea while monitoring for safety and efficacy of the active intervention
    Other Name: HY01 Topical Gel, 3%
  • Other: Topical Vehicle Gel
    Treating Papulopustular Rosacea while monitoring for safety and efficacy of the vehicle intervention
    Other Name: HY01 Topical Gel, 0%
Study Arms  ICMJE
  • Placebo Comparator: Topical Vehicle Gel
    Topical administration of vehicle gel. Regimen: Apply once daily, at bedtime to the face
    Intervention: Other: Topical Vehicle Gel
  • Active Comparator: 1% Topical Minocycline Gel
    Topical administration of 1% Topical Minocycline Gel. Regimen: Apply once daily, at bedtime to the face
    Intervention: Drug: 1% Topical Minocycline Gel
  • Active Comparator: 3% Topical Minocycline Gel
    Topical administration of 3% Topical Minocycline Gel. Regimen: Apply once daily, at bedtime to the face
    Intervention: Drug: 3% Topical Minocycline Gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2019)
270
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2017)
249
Actual Study Completion Date  ICMJE July 1, 2019
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03263273
Other Study ID Numbers  ICMJE HY01-003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hovione Scientia Limited
Study Sponsor  ICMJE Hovione Scientia Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sunil S Dhawan, MD Center for Dermatology Clinical Research, Inc.
PRS Account Hovione Scientia Limited
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP