SCD-044 for Eczema

(SOLARES-AD-1 Trial)

Recruiting at 84 trial locations

Overseen By Head, Clinical development

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sun Pharmaceutical Industries Limited

Disqualifiers: Pregnancy, Diabetes complications, Uveitis

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 32 weeks

250 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called SCD-044 to see if it can help people with moderate to severe atopic dermatitis by reducing symptoms like itching and inflammation.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

How is the drug SCD-044 for eczema different from other treatments?

SCD-044 is unique because it involves multiple dosage levels being tested, which may help determine the most effective dose for treating eczema. Unlike standard treatments like topical corticosteroids or systemic immunosuppressants, SCD-044's specific mechanism of action and its potential benefits over existing therapies are still being explored in clinical trials. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

I have had chronic atopic dermatitis for over a year.

I am 18 years old or older.

I have moderate to severe eczema.

Exclusion Criteria

I am not pregnant, nursing, or planning to become pregnant soon.

I have diabetes-related complications like kidney issues, eye problems, or nerve damage.

I have had or currently have uveitis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SCD-044 or placebo tablets for the treatment of moderate to severe atopic dermatitis

32 weeks

Regular visits for assessment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• SCD-044_Dose 1
• SCD-044_Dose 2
• SCD-044_Dose 3

Trial Overview 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.

Participant Groups

Group I: SCD-044 Tablets_Dose 1 Active Control 1 Intervention

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

Group II: SCD-044 Tablets_Dose 2 Active Control 1 Intervention

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

Group III: SCD-044 Tablets_Dose 3 Active Control 1 Intervention

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

Group IV: Placebo of SCD-044 product Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Sun Pharmaceutical Industries Limited

Lead Sponsor

Trials

71

Recruited

14,000+

Dilip Shanghvi

Sun Pharmaceutical Industries Limited

Chief Executive Officer since 1993

Majored in Cellular and Molecular Biology at the University of Michigan – Ann Arbor

Dr. Azadar H. Khan

Sun Pharmaceutical Industries Limited

Chief Medical Officer since 2023

MD from a recognized institution

Findings from Research

In a study involving 100 patients with eczema/atopic dermatitis, clocortolone pivalate 0.1% cream was found to be significantly more effective than a placebo in all measured outcomes, both objective and subjective.

The treatment was well-tolerated with no adverse reactions reported, indicating a high level of safety and excellent patient acceptance for both the active and placebo creams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clocortolone pivalate: a paired comparison clinical trial of a new topical steroid in eczema/atopic dermatitis. Rosenthal, AL.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Dupilumab for Allergic Contact Dermatitis: An Overview of Its Use and Impact on Patch Testing. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Guidelines for diagnosis, prevention and treatment of hand eczema--short version. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Dose ranging study: cetirizine in the treatment of atopic dermatitis in adults. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of the ascomycin macrolactam SDZ ASM 981 in the topical treatment of atopic dermatitis. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Clocortolone pivalate: a paired comparison clinical trial of a new topical steroid in eczema/atopic dermatitis. [2019]