Phase
Condition
Atopic Dermatitis
Dermatitis, Atopic
Rosacea
Treatment
Vehicle
Triamcinolone Acetonide (Aristocort® C)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 andRajka criteria.
Subject has at least a 6-month history of AD and had no significant flares in AD forat least 4 weeks before screening.
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:
Subject is a female who is breastfeeding, pregnant, or who is planning to becomepregnant 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 priorto Day 1.
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.
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.
Study Design
Study Description
Connect with a study center
Innovaderm Research Inc.
Montréal, Quebec H2X 2V1
CanadaSite Not Available
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