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A Study Comparing Oxymetazoline 1% Cream to RHOFADE

Sponsor
Taro Pharmaceuticals USA (Industry)
Overall Status
Completed
CT.gov ID
NCT05148689
Collaborator
(none)
82
Enrollment
1
Location
3
Arms
15.2
Actual Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

randomized, double-blind, placebo controlled

Condition or Disease Intervention/Treatment Phase
  • Drug: Oxymetazoline hydrochloride Cream, 1%
  • Drug: Rhofade™ (oxymetazoline) cream, 1%
  • Drug: Placebo
 Phase 1

Detailed Description

Subjects in this randomized, double-blind, placebo controlled study will be randomly assigned to treatment sequences with the test product, reference product or placebo control.

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double-blind, Randomized, Placebo Controlled Study, Comparing Oxymetazoline 1% Cream TO RHOFADE in the Treatment of Moderate to Severe Persistent Facial Erythema Assocoated With Rosacea
Actual Study Start Date :
Feb 23, 2018
Actual Primary Completion Date :
Mar 21, 2019
Actual Study Completion Date :
May 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: test product

Oxymetazoline Cream, 1%

Drug: Oxymetazoline hydrochloride Cream, 1%
Cream
Other Names:
  • Oxymetazoline

    		•
    Active Comparator: reference

    Rhofade™ (oxymetazoline) cream, 1%

    Drug: Rhofade™ (oxymetazoline) cream, 1%
    cream
    Placebo Comparator: placebo

    Vehicle of Test product

    Drug: Placebo
    cream

    Outcome Measures

    Primary Outcome Measures

    1. erythema response success [21 day]

      at least a 2-grade improvement in both CEA and PSA

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Healthy male or non-pregnant female aged ≥18 years with a clinical diagnosis of facial rosacea;

    2. Provided IRB approved written informed consent;

    3. A CEA score of ≥3 prior to study drug application

    4. A PSA score of ≥3 prior to study drug application

    Exclusion Criteria:

    1. Female subjects who were pregnant, nursing, or had planned to become pregnant during study participation;

    2. History of hypersensitivity to the study product;

    3. Presence of ≥3 facial inflammatory lesions of rosacea;

    4. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, and isolated pustulosis of the chin);

    5. Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression;

    6. Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that could interfere with diagnosis or study assessments;

    7. Presence of significant hypertension or circulatory disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 WAYcro Dallas Texas United States 75234

    Sponsors and Collaborators

    • Taro Pharmaceuticals USA

    Investigators

    • Study Chair: Kelly Walker, WayCro / Trial Clinsultants

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Taro Pharmaceuticals USA
    ClinicalTrials.gov Identifier:
    NCT05148689
    Other Study ID Numbers:
    • XMTC-1810
    First Posted:
    Dec 8, 2021
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Phenylephrine
    Oxymetazoline

    Study Results

    No Results Posted as of Dec 8, 2021