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Completed

NCT Number: NCT04684485

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.

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Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinica Dermatologica, San Salvador, El Salvador

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

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Treatment and study plan

Placebo

Drug

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

SCD-044_Dose 1

Drug

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

SCD-044_Dose 2

Drug

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

SCD-044_Dose 3

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  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.

    Time frame: 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.

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

    Time frame: Week 32

    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.

  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.

    Time frame: Week 32

    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.

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

    Time frame: Week 32

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

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

    Time frame: Week 32

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

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

    Time frame: Week 32

    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

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

    Time frame: Week 32

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

    Time frame: Week 32

    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.

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

    Time frame: Week 32

    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.

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

    Time frame: Week 32

    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.

  11. Adverse Events.

    Time frame: Week 36

    Total Number Affected by adverse events from Baseline through Week 36

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries Limited

Industry

Registry information

Official study 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

Acronym: SOLARES-AD-1

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Dec 24, 2020
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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