NCT03536637

Brief Summary

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 vulgaris.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2018

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

May 2, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

May 22, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2019

Completed
Last Updated

July 22, 2020

Status Verified

June 1, 2018

Enrollment Period

7 months

First QC Date

May 2, 2018

Last Update Submit

July 20, 2020

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

  • Efficacy as measured by lesion counts

    Inflammatory and Noninflammatory

    12 weeks

  • Efficacy as measured by Investigator Global Assessment (IGA)

    0 None No evidence of facial acne vulgaris 1. Minimal Few noninflammatory lesions (comedones) are present; a few inflammatory lesions(papules/pustules) may be present; no nodulo-cystic lesions are allowed) 2. Mild Several to many noninflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed 3. Moderate Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed 4. Severe Significant degree of inflammatory disease; papules/pustules are a predominant feature; a few nodulo-cystic lesions may be present; comedones may be present

    12 weeks

Secondary Outcomes (1)

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

    12 weeks

Study Arms (4)

Study Treatment 1

EXPERIMENTAL

DMT310 Powder mixed with Hydrogen Peroxide

Drug: DMT310Drug: Hydrogen Peroxide

Study Treatment 2

EXPERIMENTAL

DMT310 Powder mixed with Placebo Diluent

Drug: DMT310

Study Treatment 3

EXPERIMENTAL

Placebo powder mixed with Hydrogen Peroxide

Drug: Hydrogen PeroxideDrug: Placebo

Control

PLACEBO COMPARATOR

Placebo powder mixed with Placebo Diluent

Drug: Placebo

Interventions

DMT310DRUG

Topical Powder

Study Treatment 1Study Treatment 2
Hydrogen PeroxideDRUG

Liquid Diluent

Study Treatment 1Study Treatment 3
PlaceboDRUG

Placebo Topical Powder

ControlStudy Treatment 3

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (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 acne vulgaris as determined by:
  • Investigator's Global Assessment (IGA) at Randomization Patient has at least 20 but not more than 50 inflammatory lesions on the face Patient has at least 20 but not more than 100 noninflammatory lesions on the face
  • 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 on the face which may affect the patient's acne

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Dermata Investigational Site

San Diego, California, 92123, United States

Location

Dermata Investigational Site

Saint Joseph, Missouri, 64506, United States

Location

Dermata Investigational Site

Henderson, Nevada, 89148, United States

Location

Dermata Investigational Site

Albuquerque, New Mexico, 87106, United States

Location

Dermata Investigational Site

High Point, North Carolina, 27262, United States

Location

Dermata Investigational Site

Tennessee City, Tennessee, 37215, United States

Location

Dermata Investigational Site

Austin, Texas, 78759, United States

Location

Dermata Investigational Site

College Station, Texas, 77802, United States

Location

Dermata Investigational Site

Katy, Texas, 77494, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Hydrogen Peroxide

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

PeroxidesOxidesAnionsIonsElectrolytesInorganic ChemicalsReactive Oxygen SpeciesFree RadicalsOxygen CompoundsOrganic Chemicals

Study Design

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

Study Record Dates

First Submitted

May 2, 2018

First Posted

May 25, 2018

Study Start

May 22, 2018

Primary Completion

December 30, 2018

Study Completion

January 28, 2019

Last Updated

July 22, 2020

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(9)