Clinical trial

A Study Of The Tolerability, Safety, And Efficacy Of DMT310 For The Treatment Of Acne Rosacea

Name

DMT310-005

Description

The objective is to evaluate the tolerability, safety, and efficacy of DMT310 topical powder mixed with diluent in male and female patients with moderate to severe facial acne rosacea.

Trial arms

Trial start

2021-11-15

Estimated PCD

2022-12-01

Trial end

2022-12-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Topical Powder

Topical Powder mixed with diluent

Arms:

Study Treatment 1

Placebo Topical Powder

Placebo Topical Powder mixed with diluent

Arms:

Study Treatment 2

Size

180

Primary endpoint

Efficacy as measured by lesion counts

12 Weeks

Efficacy as measured by Investigator Global Assessment (IGA)

12 Weeks

Eligibility criteria

Inclusion Criteria: Patient is male or non-pregnant female at least 18 years of age. Clinical diagnosis of moderate to severe papulopustular acne rosacea as determined by: Investigator's Global Assessment (IGA) at Randomization score of 3 or 4. Patient has at least 15 inflammatory lesions on the face Patient is willing to apply the Investigational Product as directed Patient is willing and able to comply with the protocol Exclusion Criteria: Patient is pregnant or planning to become pregnant Patient is taking a topical therapy on the face which may affect the patient's rosacea

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 180, 'type': 'ACTUAL'}}

Updated at

2022-12-08

1 organization

2 products

1 indication

Organization

Product

Indication

Product