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DMT310-009 Topical in the Treatment of Acne Vulgaris

D

Dermata Therapeutics

Status and phase

Enrolling
Phase 3

Conditions

Acne Vulgaris

Treatments

Drug: DMT310
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06090721
DMT310-009

Details and patient eligibility

About

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

Enrollment

555 estimated patients

Sex

All

Ages

9+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient sex at birth, male or non-pregnant female at least 9 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 inflammatory lesions and at least 20 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

555 participants in 2 patient groups

DMT310 Topical Powder
Experimental group
Description:
DMT310 Powder mixed with Hydrogen Peroxide
Treatment:
Drug: DMT310
Placebo Topical Powder
Experimental group
Description:
Placebo powder mixed with Hydrogen Peroxide
Treatment:
Drug: Placebo

Trial contacts and locations

2

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Central trial contact

Dermata Study Director

Data sourced from clinicaltrials.gov

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