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

Last updated: March 24, 2025
Sponsor: Innovaderm Research Inc.
Overall Status: Completed

Phase

4

Condition

Atopic Dermatitis

Dermatitis, Atopic

Rosacea

Treatment

Vehicle

Triamcinolone Acetonide (Aristocort® C)

Clinical Study ID

NCT05844618
Inno-5011
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female subjects 18 years of age or older at the time of consent.

  2. Subject has clinically confirmed diagnosis of active AD, according to Hanifin andRajka criteria.

  3. Subject has at least a 6-month history of AD and had no significant flares in AD forat least 4 weeks before screening.

  4. Subject has 2 applications areas (10 X 10 cm) with a lesional surface of at least 6X 6 cm, preferably located on 2 distinct anatomical areas at Day 1.

Exclusion

Exclusion Criteria:

  1. Subject is a female who is breastfeeding, pregnant, or who is planning to becomepregnant during the study.

  2. Subject has clinically infected AD.

  3. Subject has a Fitzpatrick's Skin Phototype ≥5.

  4. 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.

  5. Subject is known to have immune deficiency or is immunocompromised.

  6. Subject has a history of cancer or lymphoproliferative disease within 5 years priorto Day 1.

  7. Subject has any clinically significant medical condition that would, in the opinionof the investigator, put the subject at undue risk or interfere with interpretationof study results.

  8. Subject has a known history of chronic infectious disease.

  9. Subject has a known or suspected allergy to triamcinolone acetonide (Aristocort® C)or any component of the investigational product.

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Vehicle
Phase: 4
Study Start date:
May 09, 2023
Estimated Completion Date:
March 24, 2025

Study Description

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.

Connect with a study center

  • Innovaderm Research Inc.

    Montréal, Quebec H2X 2V1
    Canada

    Site Not Available

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