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Dermatitis, AtopicPhase 2SOLARES-AD-1NCT04684485

To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis

A Phase 2 study testing SCD-044_Dose 1, SCD-044_Dose 2 and SCD-044_Dose 3 in people with Dermatitis, Atopic, run by Sun Pharmaceutical Industries Limited at 58 sites in 5 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a Phase II, randomized, double-blind, placebo-controlled study in subjects with moderate to severe atopic dermatitis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dermatitis, Atopic
What is being tested?
SCD-044_Dose 1, SCD-044_Dose 2 and SCD-044_Dose 3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
58 sitesin 5 countries
Study dates
30 Jul 2021to 18 Mar 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged at least 18 years.
  • Males and non-pregnant non-lactating females, diagnosed with chronic atopic dermatitis for ≥ 1 year at Screening and Baseline based on Eichenfield revised criteria of Hanifin and Rajka.
  • Moderate to severe atopic dermatitis at Screening and Baseline

Who cannot join

  • Female Subjects who are pregnant, nursing, or planning to become pregnant during study participation or within 6 months of completing the study.
  • Known organ complications of Diabetes mellitus such as reduced renal function, significant retinal pathology or neuropathy.
  • History or presence of uveitis
  • -

Trial locations and contacts

58 sites in 5 countries.

58 sites in 5 countries

United States34 sites
  • Skin DC Derm

    Arlington, Virginia, 22209

  • Clarity Dermatology

    Castle Rock, Colorado, 80109

  • Oracle Clinical Research

    College Park, Georgia, 30349

  • DFW Clinical Research

    Dallas, Texas, 75234

  • Accel Research Sites Network - Annexus Dermatology & Aestheitcs

    DeLand, Florida, 32720

  • Revival Research Corporation

    Doral, Florida, 33122

  • 3A Research

    El Paso, Texas, 79902

  • T. Joseph Raoof Md, Imc./Encino Research Center

    Encino, California, 91436

  • Advanced Clinical Research Institute

    Florida City, Florida, 33607

  • FXM Clinical Research Fort Lauderdale

    Fort Lauderdale, Florida, 33308

  • Direct Helpers Research Center

    Hialeah, Florida, 33012

  • Evolution Research Center

    Hialeah, Florida, 33012

  • Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research

    Hialeah, Florida, 33016

  • Evolution Clinical Trials, Inc

    Hialeah Gardens, Florida, 33016

  • Metropolis Dermatology

    Los Angeles, California, 90017

  • Axis Clinical Trials

    Los Angeles, California, 90036

  • SMS Clinical Research

    Mesquite, Texas, 75149

  • Advanced Clinical Research Network, Corp

    Miami, Florida, 33135

  • MedOne Clinical Research, LLC

    Miami, Florida, 33145

  • Century Research LLC

    Miami, Florida, 33173

  • FXM Clinical Research Miami

    Miami, Florida, 33175

  • JD Medical Group, LLC

    Miami, Florida, 33176

  • FXM Clinical Research Miramar

    Miramar, Florida, 33027

  • Providence Clinical Research

    North Hollywood, California, 91606

  • Omni Dermatology

    Phoenix, Arizona, 85018

  • Unison Clinical Trials

    Sherman Oaks, California, 91403

  • Springville Dermatology/ CCT Research

    Springville, Utah, 84663

  • Stride Clinical Research

    Sugar Land, Texas, 77479

  • Adtremed Inc

    Tampa, Florida, 33607

  • Alliance Clinical Research of Tampa

    Tampa, Florida, 33615

  • Revival research Institute, LLC

    Troy, Michigan, 48084

  • Providere' Research Inc.

    West Covina, California, 91790

  • Physicians Research Group

    West Lafayette, Indiana, 47906

  • Yuma Clinical Trials, LLC

    Yuma, Arizona, 85364

Other trials in United States

Poland13 sites
  • KLIMED

    Bialystok, 15-704

  • Synexus Polska Sp. z o.o. Branch in Gdansk

    Gdansk, 80-382

  • GLOBE Clinical Research

    Kłodzko, 57-300

  • Dobry Lekarz' Modern Therapies Center Limited Liability Company

    Krakow, 31-011

  • Landa Specialist Doctor's Offices

    Krakow, 31-156

  • Appletreeclinics Clinical Research Centre

    Lodz, 90-349

  • Dermedic Iwona Zdybska

    Lublin, 20-607

  • EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1

    Poznan, 60-309

  • TWOJA PRZYCHODNIA Medical Centre of Szczecin, Twoja Przychodnia SCM

    Szczecin, 71-500

  • National Medical Institute of the MSWiA, Clinical Department of Dermatology

    Warsaw, 02-507

  • Synexus Polska Sp. z o.o. Branch in Warsaw

    Warsaw, 02-672

  • Military Institute of Medicine - National Research Institute, Department of Dermatology CWBK

    Warsaw, 04-141

  • Synexus Polska Sp. z o.o. Branch in Wroclaw

    Wroclaw, 50-381

Other trials in Poland

Georgia7 sites
  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC

    Tbilisi, 101

  • Israeli - Georgian Medical Research Clinic Healthycore LLC

    Tbilisi, 112

  • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC

    Tbilisi, 144

  • Emergency Cardiology Center by Academician G. Chapidze LLC

    Tbilisi, 159

  • LTD Aversi Clinic

    Tbilisi, 160

  • TIM - Tbilisi Institute of Medicine LLC

    Tbilisi, 160

  • David Abuladze Georgian-Italian Clinic LLC

    Tbilisi, 179

Other trials in Georgia

El Salvador3 sites
  • Clinica Vargas

    San Salvador, CP 01101

  • Clinica Dermatologica

    San Salvador, CP 1101

  • Clinica de Dermatologia y Cirugia de Piel

    Santa Tecla, CP: 01501

Other trials in El Salvador

Estonia1 site
  • Clinical Research Centre OU

    Tartu, 50106

Other trials in Estonia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis

This is a Phase II, randomized, double-blind, placebo-controlled study in subjects with moderate to severe atopic dermatitis.

Read the detailed description

This is a Phase II, randomized, double-blind, placebo-controlled study to determine the effect of SCD-044 in subjects with moderate to severe atopic dermatitis.

Being tested
Placebo, SCD-044_Dose 1, SCD-044_Dose 2, SCD-044_Dose 3
Medical subject headings
Dermatitis, Atopic

What participants receive

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

  • PlaceboDrug

    Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.

  • SCD-044_Dose 1Drug

    SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.

  • SCD-044_Dose 2Drug

    SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.

  • SCD-044_Dose 3Drug

    SCD-044 tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.

Study groups in NCT04684485
Study groupRoleWhat they receive
Placebo of SCD-044 productPlacebo comparatorPlacebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
Receives: Drug: Placebo
SCD-044 Tablets_Dose 1Active comparatorSCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
Receives: Drug: SCD-044_Dose 1
SCD-044 Tablets_Dose 2Active comparatorSCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
Receives: Drug: SCD-044_Dose 2
SCD-044 Tablets_Dose 3Active comparatorSCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
Receives: Drug: SCD-044_Dose 3

What is being measured

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

  1. Proportion of Subjects Who Achieve ≥75% Overall Improvement in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16.

    Based on gross morphological findings, scores will be assigned on a 4-point scale ['0' (absent), '1' (mild), '2' (moderate) and '3' (severe)] for each clinical sign.

    The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.

    Measured: Week16

Secondary outcomes (11)
  1. Proportion of Subjects Who Achieve Score of '0' (Clear) or '1' (Almost Clear) on a 5-point, vIGA Scale and ≥2 Point Reduction From Baseline to Week 16.

    Based on morphological findings (overall appearance of the lesions at a given time point), scores will be assigned on a 5-point scale ('0' [clear] to 4 [severe]).

    The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.

    Measured: Week 16

  2. Percent Change in Mean Eczema Area and Severity Index (EASI) Score

    Based on gross morphological findings, scores will be assigned on a 4-point scale ['0' (absent), '1' (mild), '2' (moderate) and '3' (severe)] for each clinical sign.

    Measured: Week 32

  3. Proportion of Subjects Who Achieve Score of '0' (Clear) or '1' (Almost Clear) on a 5-point, Validated Investigator's Global Assessment (vlGA) Scale and ≥2 Point Reduction From Baseline.

    Based on morphological findings (overall appearance of the lesions at a given time point), scores will be assigned on a 5-point scale ('0' [clear] to 4 [severe]).

    The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.

    Measured: Week 32

  4. Proportion of Subjects Who Achieve ≥4-point Improvement in Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline.

    The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.

    Measured: Week 32

  5. Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32

    The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.

    Measured: Week 32

  6. Change From Baseline in Quality of Life Measured by Dermatology Life Quality Index (DLQI) Scores.

    Based on 10-item questionnaire on skin problems (0 to 3 scale). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

    The scoring of each question is as follows:

    3=Very much; 2= A lot;

    1= A little; 0= Not at all

    Measured: Week 32

  7. Percent Change From Baseline in Body Surface Area (BSA) With Atopic Dermatitis

    Measured: Week 32

  8. Change From Baseline in Patient Oriented Eczema Measure (POEM) Score

    Subjects will be asked to complete a 7-item questionnaire about their atopic dermatitis over the past week. Each of the seven questions carries equal weight and is scored from 0 to 4 as follows

    4= Every day; 3= 5-6 days; 2= 3-4 days;

    1= 1-2 days; 0= No days

    The POEM scores can be understood as follows:

    0 to 2= Clear or almost clear 3 to 7= Mild eczema 8 to 16= Moderate eczema 17 to 24= Severe eczema 25 to 28= Very severe eczema

    The higher the score, the more quality of life is impaired.

    Measured: Week 32

  9. Proportion of Subjects With Improvement in Patient Global Impression of Change (PGIC) Score

    The subjects will be asked to assess if there has been an improvement or decline in clinical status using a 5-point scale depicting a subject's rating of overall improvement.

    The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.

    Measured: Week 32

  10. Patient Global Impression of Severity (PGIS) of Disease Score

    The subjects will be asked to assess their overall impression of disease severity over the past week using a scale of None, Mild, Moderate or Severe.

    Measured: Week 32

  11. Adverse Events.

    Total Number Affected by adverse events from Baseline through Week 36

    Measured: Week 36

Timeline

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

  1. First posted24 Dec 2020
  2. Study start30 Jul 2021
  3. Primary completion11 Nov 2024
  4. Study completion18 Mar 2025

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
Double blind
Who is masked
Participant, Investigator
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04684485
Sponsor's protocol ID
SCD-044-19-16
Acronym
SOLARES-AD-1
Status last verified
Dec 2025
First submitted
21 Dec 2020
Last updated
30 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SCD-044_Dose 1, SCD-044_Dose 2 and SCD-044_Dose 3 in people with Dermatitis, Atopic, run by Sun Pharmaceutical Industries Limited at 58 sites in 5 countries.

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 3 inclusion and 4 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 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Poland, Georgia, El Salvador, Estonia. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 30 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Subjects Who Achieve ≥75% Overall Improvement in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16. (time frame: Week16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 30 Dec 2025.

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