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Oxymetazoline

Phase 3

Rosacea | Small molecule | Dermatology |Teva Pharmaceutical Industries Limited|Last Updated: Jun 23, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment1,105

FDA Designations

No designations recorded

Clinical trial landscape

Oxymetazoline · 1 trial · 1 indication

Phase 3 1
NCT03954444A Clinical Endpoint Bioequivalence Study of "Oxymetazoline Hydrochloride Cream"Rosacea
COMPLETED1,105 Analytics
PHASE3COMPLETED
A Clinical Endpoint Bioequivalence Study of "Oxymetazoline Hydrochloride Cream"
RosaceaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Subjects With Treatment Success at All Time Points 3, 6, 9 and 12 Hours Post-application on Day 29. Treatment Success Was Defined as Having a Clinician Erythema Assessment Score at Least 2 Grades Lower Than the Baseline (Day 1 Predose) Value
29 days

The primary efficacy endpoint was the proportion of subjects with treatment success at all time points 3, 6, 9, and 12 hours post-application on Day 29. Treatment success was defined as having CEA score at least 2 grades lower than the baseline (Day 1 pre-dose) value. Clinician Erythema Assessment was measured as (0-clear, 1-almost clear, 2-mild, 3-moderate, 4- severe).

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Oxymetazoline hydrochloride Cream, 1%ACTIVE_COMPARATOROxymetazoline hydrochloride cream, 1%
RHOFADE Cream, 1%ACTIVE_COMPARATORRHOFADE Cream, 1%
Vehicle CreamPLACEBO_COMPARATORVehicle cream

Interventions

NameTypeDescription
Oxymetazoline HydrochlorideDRUGTest Comparator
Rhofade Cream, 1%DRUGReference Comparator
PlaceboDRUGPlacebo Comparator
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

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 ...

Countries:United States
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Frequently asked questions about Oxymetazoline

What is Oxymetazoline used for in Rosacea?

Oxymetazoline is a small molecule being developed by Teva Pharmaceutical Industries Limited (TEVA) for the treatment of rosacea, a chronic inflammatory skin condition. It is formulated as a cream and is currently in Phase 3 clinical development. The drug is intended to address the symptoms of rosacea, though specific efficacy details are not provided.

What does Oxymetazoline target?

Oxymetazoline is a small molecule, but its specific molecular target or target class has not been disclosed in the available information. As such, the precise mechanism of action for its use in rosacea is not detailed. The drug is being studied in a Phase 3 clinical trial for this dermatological condition.

Who makes Oxymetazoline?

Oxymetazoline is being developed by Teva Pharmaceutical Industries Limited, a global pharmaceutical company traded under the ticker TEVA. The drug is currently in Phase 3 clinical development for the treatment of rosacea, a dermatological condition. Teva is conducting clinical trials to evaluate the safety and efficacy of this small molecule cream.

What phase is Oxymetazoline in?

Oxymetazoline is in Phase 3 clinical development for the treatment of rosacea. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial, NCT03954444, has been completed, involving 1,105 participants. The drug is being developed as a cream formulation by Teva Pharmaceutical Industries Limited.

What clinical trials is Oxymetazoline in?

Oxymetazoline has one completed Phase 3 clinical trial, NCT03954444, titled "A Clinical Endpoint Bioequivalence Study of Oxymetazoline Hydrochloride Cream." This randomized, double-blind, placebo-controlled trial enrolled 1,105 participants with rosacea in the United States. The study included healthy volunteers and was designed to assess bioequivalence, though specific results are not provided.

Is Oxymetazoline the same as other rosacea treatments?

Oxymetazoline is a distinct small molecule being developed for rosacea, but no alternative names or comparisons to other treatments are provided in the available information. It is currently in Phase 3 clinical development by Teva Pharmaceutical Industries Limited. The drug's specific relationship to other rosacea therapies is not detailed.