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Atopic DermatitisPhase 2NCT03175354

A Study in Subjects With Moderate Atopic Dermatitis

A Phase 2 study of Atopic Dermatitis and Eczema, Atopic, run by Ralexar Therapeutics, Inc. at 35 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, double-blind, vehicle-controlled study to evaluate the safety and efficacy of ALX-101 Gel 1.5% and 5% and a matching ALX-101 Gel Vehicle when applied topically twice daily for 42 days to adult and adolescent subjects with moderate atopic dermatitis. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Atopic Dermatitis, Eczema, Atopic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
209 participants
Where
35 sitesUnited States
Study dates
26 Apr 2017to 29 Jun 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • In order to be eligible for the study, subjects must fulfill all of the following criteria:
  • Subject is at least 12 years of age
  • Subject has a clinical diagnosis of stable AD characterized by:
  • Pruritus
  • Eczema (acute, subacute, chronic)
  • Typical morphology and distribution with age-specific patterns
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  • Chronic or relapsing history
  • Subject must have active AD covering 4-24% body surface area (BSA) (right and left treatment areas combined)
  • Bilateral treatment areas of AD must be 5 cm apart
  • Presence of AD with comparable bilateral target evaluation areas on (right and left sides of body) and within each bilateral treatment area:
  • Bilateral target evaluation areas must each have active AD covering 0.5 -2% body surface area (BSA)
  • Bilateral target evaluation areas of AD must each have a Physician's Global Assessment score of 3 ("moderate") to be treated
  • Subject Visit 1 photographs are approved for enrollment by dermatology assessor
  • If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control for the duration of the study
  • Subject is non-pregnant and non-lactating
  • Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of the AD being treated or which exposes the subject to an unacceptable risk by study participation
  • Subject is willing and able to follow all study instructions and to attend all study visits
  • Subject is able to comprehend and willing to sign an Informed Consent Form (ICF)/Assent Form (AF)
  • Parent/guardian has the ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol-related procedures as applicable; subject has the ability to give assent in the Assent Form (AF)
  • All female subjects of childbearing potential must use acceptable methods of contraception from the Screening Visit continuously until 14 days after stopping study drug.

Who cannot join

  • Any subject who meets one or more of the following criteria will not be included in this study:
  • Subject has spontaneously improving or rapidly deteriorating AD
  • Subject has clinically infected AD
  • Subject has any signs or symptoms associated with topical AD therapy (e.g., history of anaphylaxis, hypersensitivity reactions, skin atrophy, striae, pigmentary changes) which, in the investigator's opinion, might impair evaluation of the AD being treated or which exposes the subject to an unacceptable risk by study participation
  • Subject has used any systemic immunosuppressive or immunomodulatory therapy (e.g., etanercept, alefacept, infliximab) within 16 weeks prior to Visit 1
  • Subject has used any phototherapy (e.g., ultraviolet A, ultraviolet B) which, in the investigator's opinion, might affect AD within 4 weeks prior to Visit 1
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  • Subject has used any systemic therapy (e.g., systemic corticosteroids [intranasal and inhaled corticosteroids are allowed]), prednisone cyclosporine, immunosuppressants/immunomodulators, Janus Kinase (JAK) inhibitors, methotrexate, cytostatics) within 4 weeks prior to Visit 1 which, in the investigator's opinion, might impair evaluation of the AD being treated or which exposes the subject to an unacceptable risk by study participation
  • Subject has used any systemic antibiotics within 2 weeks prior to Visit 1
  • Subject has used any topical AD therapy (e.g., corticosteroids, calcineurin inhibitors, topical H1 and H2 antihistamines, topical antimicrobials, and other medicated topical agents) on the planned treatment area(s) within one week prior to Visit 1
  • Subject has used emollients/moisturizers on the planned treatment area(s) within 4 hours prior to Visit 1
  • Subject is currently using H1 antihistamines (e.g., diphenhydramine, terfenadine) UNLESS a stable dose has been used for at least 14 days prior to Visit 1
  • Subject has a history of sensitivity to any of the ingredients in the study medications
  • Subject has any known concomitant dermatologic or medical condition which, in the investigator's opinion, might impair evaluation of the bilateral treatment and/or target evaluation areas of AD being treated or which exposes the subject to an unacceptable risk by study participation (e.g., psoriasis, lichen planus, lichen simplex chronicus,…)
  • Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United States35 sites

  • Ralexar Investigational Site 26

    Albuquerque, New Mexico, 87106

  • Ralexar Investigational Site 35

    Anniston, Alabama, 36207

  • Ralexar Investigational Site 19

    Austin, Texas, 78745

  • Ralexar Investigational Site 31

    Austin, Texas, 78759

  • Ralexar Investigational Site 12

    Beachwood, Ohio, 44122

  • Ralexar Investigational Site 21

    Birmingham, Alabama, 35209

  • Ralexar Investigational Site 28

    Charlotte, North Carolina, 28217

  • Ralexar Investigational Site 5

    Cincinnati, Ohio, 45236

  • Ralexar Investigational Site 15

    Fridley, Minnesota, 55432

  • Ralexar Investigational Site 8

    Johnston, Rhode Island, 02919

  • Ralexar Investigational Site 18

    Laguna Hills, California, 92653

  • Ralexar Investigational Site 23

    Los Angeles, California, 90045

  • Ralexar Investigational Site 32

    Louisville, Kentucky, 40202

  • Ralexar Investigational Site 7

    Louisville, Kentucky, 40241

  • Ralexar Investigational Site 1

    Miami, Florida, 33143

  • Ralexar Investigational Site 9

    Nashville, Tennessee, 37215

  • Ralexar Investigational Site 17

    New Albany, Indiana, 47150

  • Ralexar Investigational Site 20

    New York, New York, 10075

  • Ralexar Investigational Site 24

    Oceanside, California, 92056

  • Ralexar Investigational Site 3

    Oklahoma City, Oklahoma, 73112

  • Ralexar Investigational Site 14

    Pinellas Park, Florida, 33781

  • Ralexar Investigational Site 4

    Plano, Texas, 75024

  • Ralexar Investigational Site 13

    Richmond, Virginia, 23220

  • Ralexar Investigational Site 25

    Saint Joseph, Missouri, 64506

  • Ralexar Investigational Site 2

    San Antonio, Texas, 78218

  • Ralexar Investigational Site 34

    San Diego, California, 92103

  • Ralexar Investigational Site 16

    San Diego, California, 92108

  • Ralexar Investigational Site 33

    San Diego, California, 92121

  • Ralexar Investigational Site 27

    Santa Monica, California, 90404

  • Ralexar Investigational Site 29

    Snellville, Georgia, 30078

  • Ralexar Investigational Site 6

    Spartanburg, South Carolina, 29303

  • Ralexar Investigational Site 10

    Spokane, Washington, 99202

  • Ralexar Investigational Site 30

    Stony Brook, New York, 11790

  • Ralexar Investigational Site 22

    Tampa, Florida, 33618

  • Ralexar Investigational Site 11

    Warren, Michigan, 48088

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Bilateral, Vehicle-Controlled Study of the Safety and Efficacy of ALX-101 Topical Gel Administered Twice Daily in Adult and Adolescent Subjects With Moderate Atopic Dermatitis

This is a randomized, double-blind, vehicle-controlled study to evaluate the safety and efficacy of ALX-101 Gel 1.5% and 5% and a matching ALX-101 Gel Vehicle when applied topically twice daily for 42 days to adult and adolescent subjects with moderate atopic dermatitis.

Read the detailed description

The main objectives of this study are to:

  • Evaluate the safety and tolerability of ALX-101 Gel 1.5% and 5% when applied topically in subjects with moderate atopic dermatitis compared with a matching ALX-101 Gel Vehicle
  • Evaluate the dose-response relationship of ALX-101 Gel 1.5% and 5% when applied topically twice daily in subjects with moderate atopic dermatitis compared with a matching ALX-101 Gel Vehicle.
Being tested
ALX-101 Gel 1.5% and ALX-101 Gel Vehicle, ALX-101 Gel 5% and ALX-101 Gel Vehicle
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALX-101 Gel 1.5% and ALX-101 Gel VehicleDrug

    Bilateral application of ALX-101 Gel 1.5% and ALX-101 Gel Vehicle

  • ALX-101 Gel 5% and ALX-101 Gel VehicleDrug

    Bilateral application of ALX-101 Gel 5% and ALX-101 Gel Vehicle

Study groups in NCT03175354
Study groupRoleWhat they receive
ALX-101 Gel 1.5% vs. ALX-101 Gel VehicleExperimentalALX-101 Gel 1.5% applied twice daily for 42 days to one treatment area and ALX-101 Gel Vehicle applied twice daily for 42 days to a second treatment area. Treatments will be randomly assigned to bilateral target areas.
Receives: Drug: ALX-101 Gel 1.5% and ALX-101 Gel Vehicle
ALX-101 Gel 5% vs. ALX-101 Gel VehicleExperimentalALX-101 Gel 5% applied twice daily for 42 days to one treatment area and ALX-101 Gel Vehicle applied twice daily for 42 days to a second treatment area. Treatments will be randomly assigned to bilateral target areas.
Receives: Drug: ALX-101 Gel 5% and ALX-101 Gel Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physician's Global Assessment (PGA)

    The primary effectiveness analysis will be based on mean change in PGA score from baseline (Visit 2) to Visit 6.

    Measured: Day 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2017
  2. Study start26 Apr 2017
  3. Primary completion29 Jun 2018
  4. Study completion29 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03175354
Sponsor's protocol ID
ALX-101-ATOP-202
Status last verified
Oct 2018
First submitted
1 Jun 2017
Last updated
25 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Atopic Dermatitis and Eczema, Atopic, run by Ralexar Therapeutics, Inc. at 35 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physician's Global Assessment (PGA) (time frame: Day 42). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03175354.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018; AzTrials last refreshed its copy on 29 Oct 2026.

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