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Completed

NCT Number: NCT05579899

Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis

This is a Phase 2a safety and efficacy study of EVO101 for the treatment of adults with atopic dermatitis

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Key information

Conditions

Atopic Dermatitis Eczema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Saguaro Dermatology, Phoenix, Arizona, United States

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About this study

This is a Phase 2a safety and efficacy study of EVO101 Topical Cream, 0.1%, applied twice daily for 8 weeks in adults with mild-to moderate atopic dermatitis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or non-pregnant, non-lactating females, age 18 years or older
  • Chronic atopic dermatitis for at least 1 year
  • IGA score of 2 or 3
  • BSA of AD involvement of 4-12%
  • EASI of 5-20

Exclusion criteria

  • Significant AD flare with 4 weeks
  • Use of biologic therapy within 12 weeks
  • Regular use of tanning booth within 4 weeks
  • Skin condition that could interfere with study assessments

Treatment and study plan

EVO101

Drug

Topical Cream

Primary outcomes

  1. Percent Change in Eczema Area and Severity Index (EASI) From Baseline to Week 8

    Time frame: 8 weeks

    EASI assesses the extent and severity of atopic dermatitis. EASI is a composite index with scores ranging from 0 to 72. Higher values indicate more severe or extensive disease.

Secondary outcomes

  1. Investigator Global Assessment (IGA) Response (Number of Participants With >= 2 Points Change From Baseline to Week 8)

    Time frame: 8 weeks

    The IGA assesses the overall appearance and severity of atopic dermatitis using a 5-point scale [0 (clear) to 4 (severe)]. The outcome measures is reported as the number of participants achieving a reduction of 2 or greater on the IGA from baseline to Week 8.

  2. Percent Body Surface Area (BSA) Affected by Atopic Dermatitis Over Time, Change From Baseline to Week 8

    Time frame: 8 weeks

    BSA estimates the extent of atopic dermatitis involvement and is expressed as a percentage of total body surface area. The outcome measure describes the mean change from baseline in percent of the body surface area affected by AD.

  3. Pruritus-NRS, Change From Baseline to Week 8

    Time frame: 8 weeks

    The pruritus-NRS is an 11-point scale used by subjects to rate their worst itch severity over the past 24 hours with 0 indicating "no itch" and 10 indicating "worst itch imaginable".

Sponsors and collaborators

Lead sponsor

Evommune, Inc.

Industry

Registry information

Official study title

A Randomized, Vehicle-controlled, Safety and Efficacy Study of EVO101 in Adult Subjects With Atopic Dermatitis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2022
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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