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NCT Number: NCT05844618

Short-Term Efficacy of Triamcinolone Acetonide (Aristocort® C) in Subjects with Atopic Dermatitis

This study is a randomized, intraindividual study to evaluate the short-term efficacy of triamcinolone acetonide (Aristocort® C) in subjects with atopic dermatitis.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic 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 4

Primary location

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

About this study

This study is being conducted to evaluate the short-term efficacy and effect of triamcinolone acetonide (Aristocort® C) on pruritus, skin biomarkers and skin parameters in subject with atopic dermatitis.

Approximately 20 subjects with atopic dermatitis will receive twice-daily topical application of triamcinolone acetonide (Aristocort® C) or vehicle in two different randomized areas for 3 days.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female subjects 18 years of age or older at the time of consent.
  • Subject has clinically confirmed diagnosis of active AD, according to Hanifin and Rajka criteria.
  • Subject has at least a 6-month history of AD and had no significant flares in AD for at least 4 weeks before screening.
  • Subject has 2 applications areas (10 X 10 cm) with a lesional surface of at least 6 X 6 cm, preferably located on 2 distinct anatomical areas at Day 1.

Exclusion criteria

  • Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
  • Subject has clinically infected AD.
  • Subject has a Fitzpatrick's Skin Phototype ≥5.
  • Subject has a history of skin disease or presence of skin condition, other than AD, that would interfere with the study assessments in the opinion of the investigator.
  • Subject is known to have immune deficiency or is immunocompromised.
  • Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1.
  • Subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
  • Subject has a known history of chronic infectious disease.
  • Subject has a known or suspected allergy to triamcinolone acetonide (Aristocort® C) or any component of the investigational product.

Treatment and study plan

Triamcinolone Acetonide (Aristocort® C)

Drug

On Day 1, Day 2, and Day 3, subjects will receive 2 applications of 3 mg/cm2 on the same lesional area, at an interval of approximately 12 ± 2 hours.

Vehicle

Drug

On Day 1, Day 2, and Day 3, subjects will receive 2 applications of 3 mg/cm2 on the same lesional area, at an interval of approximately 12 ± 2 hours.

Primary outcomes

  1. Change from baseline in pruritus NRS on AD lesions

    Time frame: 72 hours

    The intensity of pruritus will be evaluated using a NRS by asking subjects to assign a numerical score to the worst level of itching at each application area in the past 12 hours, on a scale from 0 to 10, where 0 indicates no itch and 10 indicates the worst imaginable itch.

Secondary outcomes

  1. Change from baseline in pruritus NRS on AD lesions

    Time frame: 12, 24, 36, 48, and 60 hours

    The intensity of pruritus will be evaluated using a NRS (Numeric Rating Scale) by asking subjects to assign a numerical score to the worst level of itching at each application area in the past 12 hours, on a scale from 0 to 10, where 0 indicates no itch and 10 indicates the worst imaginable itch.

  2. Change from baseline in skin biomarkers for AD

    Time frame: Day 2, Day 3, and Day 4

    An untargeted biomarker approach with gene expression profile of treated and untreated skin samples will be performed.

  3. Change from baseline in TSS

    Time frame: Day 4

    The TSS (Total Sign Score) is an assessment of the severity of erythema, edema/papulation, oozing/crusting, excoriation, lichenification, and dryness, each scored independently using the 4-point severity scale with a value range from 0 to 3 (clear to severe). The rating for each parameter is then summed to create a score ranging from 0 to 18.

  4. Change from baseline in TAA

    Time frame: Day 4

    The TAA (Target Areas Assessment) is a 6-point scale with a value range from 0 to 5 (clear to very severe) used to evaluate AD severity at each site of study drugs application.

  5. Change from baseline in lesion IGA

    Time frame: Day 4

    The lesion IGA (Investigator Global Assessment) is a 5-point scale with a value range from 0 to 4 (clear to severe) used for the assessment of each target lesion severity.

Sponsors and collaborators

Lead sponsor

Innovaderm Research Inc.

Other

Registry information

Official study title

A Randomized, Intraindividual, Phase 4 Study to Evaluate the Short-Term Efficacy of Triamcinolone Acetonide (Aristocort® C) in Subjects with Atopic Dermatitis

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 6, 2023
Registry last updated
Mar 26, 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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