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DMT210 Topical Gel in the Treatment of Acne Rosacea

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ClinicalTrials.gov Identifier: NCT03003104
Recruitment Status : Completed
First Posted : December 26, 2016
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Dermata Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acne Rosacea Drug: DMT210 Topical Gel 5% Other: Vehicle Control Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2017
Actual Primary Completion Date : August 30, 2017
Actual Study Completion Date : August 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Rosacea

Arms and Interventions
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Arm Intervention/treatment
Experimental: DMT210 Topical Gel
DMT210 Topical Gel 5% applied to the face twice daily for 12 weeks
 Drug: DMT210 Topical Gel 5%
Placebo Comparator: Vehicle Control
Topical Gel vehicle applied to the face twice daily for 12 weeks
 Other: Vehicle Control


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy as measured by Inflammatory lesion counts [ Time Frame: 12 weeks ]
    Inflammatory lesion counts

  2. Efficacy as measured by Investigator Global Assessment (IGA) [ Time Frame: 12 weeks ]
    Investigator Global Assessment (IGA)

  3. Efficacy as measured by 5-point Clinical Erythema Assessment (CEA) [ Time Frame: 12 weeks ]
    5-point Clinical Erythema Assessment (CEA)

  4. Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA) [ Time Frame: 12 weeks ]
    5-point Patient Severity Assessment of Erythema (PSA)


Secondary Outcome Measures :
  1. Incidence of adverse events as a measure of safety and tolerability [ Time Frame: 12 weeks ]
    Incidence of adverse events as a measure of safety and tolerability


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003104


Locations
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United States, California
Dermata Investigational Site
San Diego, California, United States
United States, Florida
Dermata Investigational Site
Miami, Florida, United States
United States, Minnesota
Dermata Investigational Site
Fridley, Minnesota, United States
United States, Nebraska
Dermata Investigational Site
Omaha, Nebraska, United States
United States, North Carolina
Dermata Investigational Site
High Point, North Carolina, United States
United States, Pennsylvania
Dermata Investigational Site
Broomall, Pennsylvania, United States
United States, Tennessee
Dermata Investigational Site
Nashville, Tennessee, United States
United States, Texas
Dermata Investigational Site
Austin, Texas, United States
United States, Virginia
Dermata Investigational Site
Norfolk, Virginia, United States
Sponsors and Collaborators
Dermata Therapeutics
More Information
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Responsible Party: Dermata Therapeutics
ClinicalTrials.gov Identifier: NCT03003104     History of Changes
Other Study ID Numbers: DMT210-003
First Posted: December 26, 2016    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dermata Therapeutics:
Skin diseases
rosacea
Additional relevant MeSH terms:
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Rosacea
Skin Diseases