Atopic Dermatitis Clinical Trial
Official title:
A Multicenter, Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in the Treatment of Children, Adolescents and Adults With Mild to Moderate Atopic Dermatitis
| Verified date | April 2024 |
| Source | Acrotech Biopharma Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a Phase 3, open-label study to evaluate the long-term safety of difamilast ointment 1% in subjects ≥2 years of age with mild to moderate AD. The study will also evaluate the long-term efficacy of difamilast ointment 1%, including durability of response.
| Status | Active, not recruiting |
| Enrollment | 500 |
| Est. completion date | October 2024 |
| Est. primary completion date | July 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years and older |
| Eligibility | Important Inclusion Criteria: 1. Subjects who are male or female =2 years of age at Screening (Visit 1). 2. Subjects who have a diagnosis of AD based on the American Academy of Dermatology AD diagnostic criteria 3. Subjects who have had a diagnosis of AD for at least 3 months prior to Screening . 4. Subjects who have an IGA of mild or moderate AD Severity and treatable body surface area (BSA) =3%at Baseline if not previously enrolled in study MEDI-MM36-301 OR b. IGA = 3, with no minimum BSA and completed through Week 4/EOT Visit 6 of the study MEDI-MM36-301. 5. Subject is willing and able to comply with all study-related procedures, including, but not limited to, application of the study drug, and visit requirements. Important Exclusion Criteria: 1. Subjects who have an AD flare (defined as rapid intensification of AD) within 28 days prior to Screening or Baseline (except for those previously enrolled in Study MEDI-MM36-301) or history of consistent requirement for high-potency topical corticosteroids to manage AD signs and symptoms. 2. Subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, or chicken pox), and/or clinically infected AD 3. Subjects with significant systemic or localized infection 4. Subjects with minimal/mild depression and suicidal ideation 5. Subjects using restricted medications, biologics and alternative therapies, or using investigational drug - |
| Country | Name | City | State |
|---|---|---|---|
| United States | Palmetto Clinical Trial Services, LLC | Anderson | South Carolina |
| United States | Arlington Research Center, Inc. | Arlington | Texas |
| United States | Oakland Hills Dermatology, PC | Auburn Hills | Michigan |
| United States | Derm Research | Austin | Texas |
| United States | Bexley Dermatology Research | Bexley | Ohio |
| United States | AllerVie Health | Birmingham | Alabama |
| United States | Qualmedica Research, LLC | Birmingham | Alabama |
| United States | Optima Research | Boardman | Ohio |
| United States | Qualmedica Research, LLC | Bowling Green | Kentucky |
| United States | TrueBlue Clinical Research | Brandon | Florida |
| United States | Metro Boston Clinical Partners | Brighton | Massachusetts |
| United States | Clarity Dermatology, LLC | Castle Rock | Colorado |
| United States | IMMUNOe Research Centers | Centennial | Colorado |
| United States | Coastal Pediatric Research | Charleston | South Carolina |
| United States | DS Research | Clarksville | Indiana |
| United States | J&S Studies | College Station | Texas |
| United States | Optimed Research | Columbus | Ohio |
| United States | Remington-Davis, Inc. | Columbus | Ohio |
| United States | Clinical Trials Management, LLC | Covington | Louisiana |
| United States | Avant Research Associates, LLC | Crowley | Louisiana |
| United States | Annexus Dermatology & Aethestics | DeLand | Florida |
| United States | Accel Research - Edgewater Clinical Research Unit | Edgewater | Florida |
| United States | Qualmedica Research, LLC | Evansville | Indiana |
| United States | First OC Dermatology | Fountain Valley | California |
| United States | Center for Dermatology Clinical Research, Inc. | Fremont | California |
| United States | North Texas Center for Clinical Research | Frisco | Texas |
| United States | Skin Care Research | Hollywood | Florida |
| United States | Center for Clinical Studies, Ltd, LLP | Houston | Texas |
| United States | Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana |
| United States | NEA Baptist Clinic-Dermatology | Jonesboro | Arkansas |
| United States | Forest Hills Dermatology Group | Kew Gardens | New York |
| United States | Cleaver Dermatology | Kirksville | Missouri |
| United States | Southern CA Dermatology Skin and Laser | Laguna Niguel | California |
| United States | Antelope Valley Clinical Trials | Lancaster | California |
| United States | Vivida Dermatology | Las Vegas | Nevada |
| United States | Dermatology Research Associates | Los Angeles | California |
| United States | DS Research | Louisville | Kentucky |
| United States | Solaris Clinical Research | Meridian | Idaho |
| United States | Clinical Trials Management, LLC | Metairie | Louisiana |
| United States | International Clinical Research - Tennessee, LLC | Murfreesboro | Tennessee |
| United States | Kirsch Dermatology | Naples | Florida |
| United States | Minnesota Clinical Study Center | New Brighton | Minnesota |
| United States | Tory Sullivan, MD PA | North Miami Beach | Florida |
| United States | Nona Pediatrics | Orlando | Florida |
| United States | Pure Skin Dermatology & Aesthetics | Orlando | Florida |
| United States | Accel Research - Ormond Clinical Research Unit | Ormond Beach | Florida |
| United States | Meridian Clinical Research | Overland Park | Kansas |
| United States | Elite Clinical Studies, LLC | Phoenix | Arizona |
| United States | The Indiana Clinical Trials Center | Plainfield | Indiana |
| United States | Research Your Health | Plano | Texas |
| United States | Dermatology Associates of Plymouth Meeting | Plymouth Meeting | Pennsylvania |
| United States | Oregon Health and Science University | Portland | Oregon |
| United States | DermAssociates, LLC | Rockville | Maryland |
| United States | Arlington Dermatology | Rolling Meadows | Illinois |
| United States | Olympian Clinical Research | Saint Petersburg | Florida |
| United States | South Bend Clinic | South Bend | Indiana |
| United States | Premier Clinical Research, LLC | Spokane | Washington |
| United States | Houston Center for Clinical Research | Sugar Land | Texas |
| United States | Clinical Trials Research Institute | Thousand Oaks | California |
| United States | Peak Research, LLC | Upper Saint Clair | Pennsylvania |
| United States | Michigan Dermatology Institute | Waterford | Michigan |
| United States | Center for Clinical Studies | Webster | Texas |
| United States | Options Research Group, LLC | West Lafayette | Indiana |
| Lead Sponsor | Collaborator |
|---|---|
| Acrotech Biopharma Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and their relationship to study drug | 52 week study period | ||
| Primary | Proportion of subjects who discontinue due to an AE over the study period | 52-week study period |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05018806 -
Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis
|
Phase 2 | |
| Completed |
NCT04090229 -
A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis
|
Phase 1 | |
| Terminated |
NCT03847389 -
Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT05388760 -
Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1)
|
Phase 2 | |
| Completed |
NCT05530707 -
Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer
|
N/A | |
| Completed |
NCT02595073 -
Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis
|
Phase 3 | |
| Recruiting |
NCT05509023 -
Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD)
|
Phase 2 | |
| Recruiting |
NCT05048056 -
Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis
|
Phase 2 | |
| Completed |
NCT04598269 -
Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis
|
Phase 2 | |
| Recruiting |
NCT03936335 -
An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
|
||
| Withdrawn |
NCT03089476 -
Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy
|
N/A | |
| Recruiting |
NCT05029895 -
A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
|
||
| Terminated |
NCT03654755 -
Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis
|
Phase 2 | |
| Completed |
NCT04556461 -
Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function
|
Phase 2 | |
| Recruiting |
NCT04818138 -
BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort
|
N/A | |
| Completed |
NCT03719742 -
A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer
|
N/A | |
| Completed |
NCT05375955 -
A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.
|
Phase 2 | |
| Completed |
NCT03441568 -
In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control
|
N/A | |
| Recruiting |
NCT06366932 -
Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models
|
Phase 4 | |
| Completed |
NCT03304470 -
A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis
|
Phase 2 |