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SCD-044 for Eczema (SOLARES-AD-1 Trial)

Phase 2

Recruiting

Research Sponsored by Sun Pharmaceutical Industries Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Aged at least 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 36

Awards & highlights

SOLARES-AD-1 Trial Summary

This trial is testing a new medication for people with moderate to severe eczema. The study is double-blind, meaning neither the participants nor the researchers will know who is receiving the medication or the placebo.

Who is the study for?

This trial is for adults over 18 with moderate to severe atopic dermatitis (eczema) that's been diagnosed for at least a year. It's not open to pregnant or nursing women, those planning pregnancy soon, or individuals with complications from diabetes like kidney issues, eye problems, or neuropathy.Check my eligibility

What is being tested?

The study tests the effectiveness and safety of SCD-044 in three different doses compared to a placebo. Participants are randomly assigned to receive either the drug or placebo without knowing which one they're getting in this Phase II trial.See study design

What are the potential side effects?

While specific side effects of SCD-044 aren't listed here, common reactions may include skin irritation at the application site, potential allergic reactions, and other symptoms typical of treatments affecting the immune system.

SOLARES-AD-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had chronic atopic dermatitis for over a year.

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I am 18 years old or older.

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I have moderate to severe eczema.

SOLARES-AD-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Adverse events.

Dermatology Life Quality Index (DLQI)

Eczema Area and Severity Index (EASI) score

+8 more

SOLARES-AD-1 Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: SCD-044 Tablets_Dose 1Active Control1 Intervention

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

Group II: SCD-044 Tablets_Dose 2Active Control1 Intervention

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

Group III: SCD-044 Tablets_Dose 3Active Control1 Intervention

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

Group IV: Placebo of SCD-044 productPlacebo Group1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sun Pharmaceutical Industries LimitedLead Sponsor

64 Previous Clinical Trials

13,271 Total Patients Enrolled

Media Library

Placebo (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04684485 — Phase 2

Atopic Dermatitis Research Study Groups: Placebo of SCD-044 product, SCD-044 Tablets_Dose 1, SCD-044 Tablets_Dose 2, SCD-044 Tablets_Dose 3

Atopic Dermatitis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04684485 — Phase 2

Placebo (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04684485 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has recruitment for this clinical experiment already begun?

"Affirmative. According to clinicaltrials.gov, this study is actively recruiting; it was first announced on July 30th 2021 and most recently modified on August 26th 2022. The research aims at enrolling 240 participants from 17 separate medical centres."

Answered by AI

How many individuals are partaking in this investigation?

"Affirmative. According to the records found on clinicaltrials.gov, this research trial is still actively recruiting participants and has been since July 30th 2021. The study requires 240 people from 17 different sites for admission."

Answered by AI

How many healthcare centers are conducting this research study within the state's border?

"This clinical trial is operating at 17 sites, which include Site #08 in West Lafayette, Site #12 in Encino and Site #16 in Arlington. The remaining fourteen locations are also included."

Answered by AI

Are there any adverse effects associated with SCD-044 Tablets_Dose 1?

"Our team at Power deem SCD-044 Tablets_Dose 1 to be a moderately safe medication, assigning it a score of 2. This evaluation is based on the fact that this is currently in Phase 2, which implies there are some safety data but none for efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04684485.

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