DMT210 Topical Gel in the Treatment of Acne Rosacea

A Randomized, Double-Blind, Vehicle Controlled Study To Evaluate The Safety, Tolerability, And Efficacy Of DMT210 Gel In Adult Patients With Moderate To Severe Acne Rosacea

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03003104

Enrollment

107

Registered

2016-12-26

Start date

2017-01-31

Completion date

2017-08-30

Last updated

2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Rosacea

Keywords

Skin diseases, rosacea

Brief summary

The study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of participants will receive DMT210 Gel while the other half will receive vehicle control.

Interventions

DRUGDMT210 Topical Gel 5%

OTHERVehicle Control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient is male or non-pregnant female at least 18 years of age. * Clinical diagnosis of moderate to severe facial rosacea as determined by Investigator's Global Assessment (IGA) at Randomization * Patient has at least ten inflammatory lesions of rosacea on the face at Randomization * 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 which may affect the patient's rosacea

Design outcomes

Primary

Measure	Time frame	Description
Efficacy as measured by Inflammatory lesion counts	12 weeks	Inflammatory lesion counts
Efficacy as measured by Investigator Global Assessment (IGA)	12 weeks	Investigator Global Assessment (IGA)
Efficacy as measured by 5-point Clinical Erythema Assessment (CEA)	12 weeks	5-point Clinical Erythema Assessment (CEA)
Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA)	12 weeks	5-point Patient Severity Assessment of Erythema (PSA)

Secondary

Measure	Time frame	Description
Incidence of adverse events as a measure of safety and tolerability	12 weeks	Incidence of adverse events as a measure of safety and tolerability

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026