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.
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
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
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
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
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.
- Conditions
- Dermatitis, Atopic
- 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 group | Role | What they receive |
|---|---|---|
| Placebo of SCD-044 product | Placebo comparator | Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis. Receives: Drug: Placebo |
| SCD-044 Tablets_Dose 1 | Active comparator | SCD-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 2 | Active comparator | SCD-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 3 | Active comparator | SCD-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.
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)
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
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
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
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
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
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
Percent Change From Baseline in Body Surface Area (BSA) With Atopic Dermatitis
Measured: Week 32
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
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
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
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.
- First posted24 Dec 2020
- Study start30 Jul 2021
- Primary completion11 Nov 2024
- Study completion18 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04684485
- Acronym / sponsor ID
- SOLARES-AD-1 / SCD-044-19-16
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Posted 30 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II, randomized, double-blind, placebo-controlled study in subjects with moderate to severe atopic dermatitis.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo of SCD-044 product | Placebo comparator | Drug: PlaceboPlacebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis. |
| SCD-044 Tablets_Dose 1 | Active comparator | Drug: SCD-044_Dose 1SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis. |
| SCD-044 Tablets_Dose 2 | Active comparator | Drug: SCD-044_Dose 2SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis. |
| SCD-044 Tablets_Dose 3 | Active comparator | Drug: SCD-044_Dose 3SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis. | Drug | Placebo of SCD-044 product |
| SCD-044_Dose 1SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis. | Drug | SCD-044 Tablets_Dose 1 |
| SCD-044_Dose 2SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis. | Drug | SCD-044 Tablets_Dose 2 |
| SCD-044_Dose 3SCD-044 tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis. | Drug | SCD-044 Tablets_Dose 3 |
Primary outcome
Proportion of Subjects Who Achieve ≥75% Overall Improvement in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16.
Time frame: Week16
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.
11 secondary outcomes
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.
Time frame: Week 16
Percent Change in Mean Eczema Area and Severity Index (EASI) Score
Time frame: Week 32
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.
Time frame: Week 32
Proportion of Subjects Who Achieve ≥4-point Improvement in Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline.
Time frame: Week 32
Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32
Time frame: Week 32
Change From Baseline in Quality of Life Measured by Dermatology Life Quality Index (DLQI) Scores.
Time frame: Week 32
Percent Change From Baseline in Body Surface Area (BSA) With Atopic Dermatitis
Time frame: Week 32
Change From Baseline in Patient Oriented Eczema Measure (POEM) Score
Time frame: Week 32
Proportion of Subjects With Improvement in Patient Global Impression of Change (PGIC) Score
Time frame: Week 32
Patient Global Impression of Severity (PGIS) of Disease Score
Time frame: Week 32
Adverse Events.
Time frame: Week 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Dermatitis, Atopic
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
58 sites in 5 countries: see every site and its status.
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.