DMT210 Topical Gel in the Treatment of Atopic Dermatitis

NCT ID: NCT02949960

Last Updated: 2018-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-07-14

Brief Summary

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The objective of the study is to evaluate the safety and efficacy of DMT210 Gel, 5% compared to vehicle control following 28 days of twice-daily topical application to selected target lesions in male and female patients with mild to moderate atopic dermatitis (AD).

Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DMT210 Topical Gel

DMT210 Topical Gel 5% applied to target lesion twice daily

Group Type EXPERIMENTAL

DMT210 Topical Gel

Intervention Type DRUG

DMT210 Topical Aqueous Gel 5% applied twice daily

Vehicle Control

Topical Gel vehicle applied to target lesion twice daily

Group Type PLACEBO_COMPARATOR

Vehicle Control

Intervention Type DRUG

Topical Vehicle Gel applied twice daily

Interventions

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DMT210 Topical Gel

DMT210 Topical Aqueous Gel 5% applied twice daily

Intervention Type DRUG

Vehicle Control

Topical Vehicle Gel applied twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female 12 years or older
* Patient has chronic, stable AD that has been present for at least 3 months with 5-35% (inclusive) BSA (Body Surface Area) of AD involvement
* Patient has two analogous, Target Lesions; one lesion within each of the two Treatment Areas
* Patient is willing and able to comply with the protocol

Exclusion Criteria

* Patient has used topical therapies for AD within the Treatment Areas 2 weeks before baseline
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dermata Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher Nardo, PhD

Role: STUDY_DIRECTOR

Dermata Therapeutics

Locations

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Dermata Investigational Site

Houston, Texas, United States

Site Status

Dermata Investigational Site

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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DMT210-002

Identifier Type: -

Identifier Source: org_study_id

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