NCT03003104

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 26, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

8 months

First QC Date

December 20, 2016

Last Update Submit

April 17, 2018

Conditions

Acne Rosacea

Keywords

Skin diseasesrosacea

Outcome Measures

Primary Outcomes (4)

  • Efficacy as measured by Inflammatory lesion counts

    Inflammatory lesion counts

    12 weeks

  • Efficacy as measured by Investigator Global Assessment (IGA)

    Investigator Global Assessment (IGA)

    12 weeks

  • Efficacy as measured by 5-point Clinical Erythema Assessment (CEA)

    5-point Clinical Erythema Assessment (CEA)

    12 weeks

  • Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA)

    5-point Patient Severity Assessment of Erythema (PSA)

    12 weeks

Secondary Outcomes (1)

  • Incidence of adverse events as a measure of safety and tolerability

    12 weeks

Study Arms (2)

DMT210 Topical Gel

EXPERIMENTAL

DMT210 Topical Gel 5% applied to the face twice daily for 12 weeks

Drug: DMT210 Topical Gel 5%

Vehicle Control

PLACEBO COMPARATOR

Topical Gel vehicle applied to the face twice daily for 12 weeks

Other: Vehicle Control

Interventions

DMT210 Topical Gel 5%DRUG
DMT210 Topical Gel
Vehicle ControlOTHER
Vehicle Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient is pregnant or planning to become pregnant
  • Patient is taking a topical therapy which may affect the patient's rosacea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Dermata Investigational Site

San Diego, California, United States

Location

Dermata Investigational Site

Miami, Florida, United States

Location

Dermata Investigational Site

Fridley, Minnesota, United States

Location

Dermata Investigational Site

Omaha, Nebraska, United States

Location

Dermata Investigational Site

High Point, North Carolina, United States

Location

Dermata Investigational Site

Broomall, Pennsylvania, United States

Location

Dermata Investigational Site

Nashville, Tennessee, United States

Location

Dermata Investigational Site

Austin, Texas, United States

Location

Dermata Investigational Site

Norfolk, Virginia, United States

Location

MeSH Terms

Conditions

RosaceaSkin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2016

First Posted

December 26, 2016

Study Start

January 1, 2017

Primary Completion

August 30, 2017

Study Completion

August 30, 2017

Last Updated

April 18, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(9)