DMT310-001 Topical in the Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

A Study of Tolerability, Safety, And Efficacy, of DMT310 In Patients With Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536637
• Other study ID #: DMT310-001
• Status: Completed
• Phase: Phase 2
• Start date: May 22, 2018
• Est. completion date: January 28, 2019

Study information

• Verified date: June 2018
• Source: Dermata Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: January 28, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 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

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 acne

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• DMT310
Topical Powder
• Hydrogen Peroxide
Liquid Diluent
• Placebo
Placebo Topical Powder

Locations

Country	Name	City	State
United States	Dermata Investigational Site	Albuquerque	New Mexico
United States	Dermata Investigational Site	Austin	Texas
United States	Dermata Investigational Site	College Station	Texas
United States	Dermata Investigational Site	Henderson	Nevada
United States	Dermata Investigational Site	High Point	North Carolina
United States	Dermata Investigational Site	Katy	Texas
United States	Dermata Investigational Site	Saint Joseph	Missouri
United States	Dermata Investigational Site	San Diego	California
United States	Dermata Investigational Site	Tennessee	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Dermata Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy as measured by lesion counts	Inflammatory and Noninflammatory	12 weeks
Primary	Efficacy as measured by Investigator Global Assessment (IGA)	0 None No evidence of facial acne vulgaris; Minimal Few noninflammatory lesions (comedones) are present; a few inflammatory lesions(papules/pustules) may be present; no nodulo-cystic lesions are allowed); Mild Several to many noninflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed; Moderate Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed; 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	Incidence of adverse events as a measure of safety and tolerability	Incidence of adverse events as a measure of safety and tolerability	12 weeks