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A Clinical Endpoint Bioequivalence Study of "Oxymetazoline Hydrochloride Cream"

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ClinicalTrials.gov Identifier: NCT03954444
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Actavis Inc.

Brief Summary:
A Randomized, Double-blind, Parallel-group, Three-arm, Placebo-controlled, Multi-Site Therapeutic Equivalence Study with Clinical End-points Comparing Test Product "Oxymetazoline hydrochloride Cream, 1%" to Reference Product "RHOFADE™ Cream, 1%" in the Treatment of Moderate to Severe Persistent Facial Erythema of Rosacea

Condition or disease Intervention/treatment Phase
Rosacea Drug: Oxymetazoline Hydrochloride Drug: Rhofade Cream, 1% Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1233 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Parallel Group, Three Arm, Placebo Controlled, Multi-Site Therapeutic Equivalence Study With Clinical End-points Comparing Test Product "Oxymetazoline Hydrochloride Cream, 1%" to Reference Product "RHOFADETM Cream, 1%" in the Treatment of Moderate to Severe Persistent Facial Erythema of Rosacea
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Active Comparator: Oxymetazoline hydrochloride Cream, 1%
Oxymetazoline hydrochloride cream, 1%
Drug: Oxymetazoline Hydrochloride
Test Comparator

Active Comparator: RHOFADE Cream, 1%
RHOFADE Cream, 1%
Drug: Rhofade Cream, 1%
Reference Comparator
Other Name: Oxymetazoline hydrochloride

Placebo Comparator: Vehicle Cream
Vehicle cream
Drug: Placebo
Placebo Comparator
Other Name: Oxymetazoline hydrochloride




Primary Outcome Measures :
  1. The therapeutic equivalence between test and reference for baseline-adjusted AUEC(ss) [ Time Frame: 29 days ]
  2. The therapeutic equivalence between test and reference for baseline-adjusted Emax(ss) [ Time Frame: 29 days ]

Secondary Outcome Measures :
  1. The therapeutic equivalence between test and reference for baseline-adjusted AUEC [ Time Frame: 1 day ]
  2. The therapeutic equivalence between test and reference for baseline-adjusted Emax [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • (1) Study subjects must have provided IRB approved written informed consent using the latest version of the IRB informed consent form, (or assent in applicable states/countries). In addition, study subjects must sign a HIPAA authorization, if applicable.
  • (2) Healthy male or non-pregnant females, ≥18 years-of-age with a clinical diagnosis of rosacea with persistent (non-transient) facial erythema.
  • (3) Ability to follow study instructions and complete subject diary without assistance.
  • (4) Females of child bearing potential must not be pregnant or lactating at screening visit and at baseline visit, as documented by a negative urine pregnancy test.
  • (5) Female subjects of childbearing potential must be willing to use an acceptable form of birth control from the day of the first dose administration to 30 days after the last administration of Investigational Product (IP). A sterile sexual partner is NOT considered an adequate form of birth control.
  • (6) Moderate to severe persistent facial erythema associated with rosacea, defined as a grade of ≥3 on the CEA scale as assessed by the Investigator at Screening and on Baseline (Day 1) visit prior to study drug application.
  • (7) Moderate to severe persistent facial erythema associated with rosacea, defined as a grade of ≥3 on the SSA scale as assessed by the subject at Screening and on Baseline (Day 1) visit prior to study drug application.
  • (8) Stable erythema (for at least 3 months prior to screening) associated with rosacea, with minimal variation from day to day and within each day, in the opinion of the subject.
  • (9) Willingness to complete the required visits including short stay for at least 12 hours at the investigational site for 2 separate visits.
  • (10) Subjects who use make-up, facial moisturizers, creams, lotions, cleansers and/or sunscreens must have used the same product brands/types for a minimum period of 4 weeks prior to Baseline, must agree not to change brand/type or frequency of use throughout the study and must agree not to use make-up, facial moisturizers, creams, lotions and/or sunscreens on the scheduled clinic visit day before the visit.
  • (11) Subject must be willing to avoid the use of abrasive cleansers or washes (e.g., exfoliating facial scrubs), adhesive cleansing strips (e.g., Bioré® Pore Strips) and wax epilation on the face, during the entire duration of their study participation.
  • (12) Subject's willingness 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, alcoholic beverages).
  • (13) Subject must be in good health and free from any systemic or dermatological disorder (other than rosacea) that, in the opinion of the Investigator, will interfere with the study evaluations or increase the risk of AEs.
  • (14) Any skin type or race, providing the skin pigmentation will allow discernment of erythema.

Exclusion Criteria:

  • (1) Any of the following conditions: severe or unstable or uncontrolled cardiovascular disease, clinically unstable hypertension, orthostatic hypotension, and uncontrolled hypertension or hypotension, cerebral or coronary insufficiency, Raynaud's Syndrome, thromboangiitis obliterans, scleroderma, Sjögren's syndrome, renal or hepatic impairment.
  • (2) Subjects with narrow angle glaucoma.
  • (3) Females who are pregnant, breast feeding, or planning a pregnancy during the study.
  • (4) Females of childbearing potential who do not agree to utilize an adequate form of contraception during their participation in the study.
  • (5) Clinical signs of particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) on the face or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia that may interfere with the study evaluations, in the opinion of the Investigator.
  • (6) Presence of ≥3 facial inflammatory lesions of rosacea at screening and baseline.
  • (7) Presence of any skin condition on the face that would interfere with the diagnosis or assessment of rosacea, as determined by the Investigator.
  • (8) Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that would interfere with the study treatments or study assessments.
  • (9) History of drug or alcohol abuse within 12 months prior to the Screening visit.
  • (10 Known hypersensitivity or allergies to any component of the study treatment.
  • (11) Use within 12 hours prior to baseline of any topical products including, but not limited to, lotions, creams, ointments, and cosmetics applied to the face (facial cleanser is acceptable).
  • (12) Use 1 week prior to baseline of niacin ≥500 mg/day.
  • (13) Use within 2 weeks prior to baseline of products containing topical corticosteroids, topical retinoids, topical antibiotics, topical anti-inflammatory, topical treatment for rosacea, or topical treatment for acne.
  • (14) Use within 4 weeks prior to baseline of topical immunomodulators, systemic antibiotics, systemic corticosteroids, systemic anti-inflammatory agents, systemic treatment for rosacea, or systemic treatment for acne (other than oral retinoids, which require a 6-month washout).
  • (15) Undergone 4 weeks prior to baseline any dermatologic or surgical procedure on the face.
  • (16) Use within 3 months prior to baseline of any systemic immunomodulators known to have an effect on rosacea.
  • (17) Use within 6 months prior to baseline of any oral retinoids (e.g., isotretinoin) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
  • (18) Undergone 6 months prior to baseline any laser, light-source (e.g. intense pulsed light, photodynamic therapy) or other energy-based therapy to the face.
  • (19) Exposed to excessive UV radiation within 1 week before Screening visit and/or subject is unwilling to refrain from excessive exposure to UV radiation during the course of the study.
  • (20) Current use of monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, alpha-agonists, cardiac glycosides, beta blockers, other antihypertensive agents, or oxymetazoline (e.g., eye drops, nasal sprays).
  • (21) Subject has participated in a clinical trial within 30 days or in a biologics study within 6 months preceding admission of this study.
  • (22) Previous participation in this study.
  • (23) Inability to communicate well (i.e., language problem, poor mental development, psychiatric illness or poor cerebral function), that may impair the ability to provide written informed consent.
  • (24) Subject has any evidence of organ dysfunction, chronic infectious disease, system disorder or has a condition or is in a situation that, in the Investigator's opinion, that may put the subject at significant risk, may confound the study results, or may significantly interferes with the subject's participation in the study.
  • (25) Employees or family members of the research center or Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954444


Contacts
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Contact: Nageshwar Thudi, Ph.D. 973-658-1835 Nageshwar.Thudi@tevapharm.com
Contact: Corrine Dias, B.Sc.

Locations
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United States, Virginia
Site 1 Recruiting
Lynchburg, Virginia, United States, 24501
Contact: Principal Investigator         
Sponsors and Collaborators
Actavis Inc.
Teva Pharmaceuticals USA

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Responsible Party: Actavis Inc.
ClinicalTrials.gov Identifier: NCT03954444     History of Changes
Other Study ID Numbers: OXY2018-01
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Rosacea
Skin Diseases
Oxymetazoline
Phenylephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Cardiotonic Agents
Mydriatics
Adrenergic alpha-1 Receptor Agonists
Protective Agents