Phase
Condition
Atopic Dermatitis
Allergy
Rash
Treatment
N/AClinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
AD diagnosis (based on Hanifin's criteria) presenting a minimum of 1% and a maximum of 10% body surface area (BSA) excluding face, groin, scalp and genital areas.
Disease severity index (EASI) of less than 12, Investigator's Global Assessment (IGA)of 2-3 at Day 0.
In good general health and free of any condition that might impair evaluation of AD.
Women of child bearing potential (WOCBP) had to have a negative a negative serumhuman-beta chorionic gonadotropin pregnancy test before randomization. WOCBP had to abstain from sex or they and their partners had to use adequate contraceptiveprecautions for the duration of the study.
Willing and able to comply with the protocol and attend all study visits.
Provide a written informed consent form prior to initiation of study procedures.
Exclusion
Exclusion Criteria:
Had spontaneously improving or rapidly deteriorating AD.
Had AD lesions on only hands and/or feet.
Had skin diseases other than AD.
Had active allergic contact dermatitis or other non-atopic forms of dermatitis.
Had other concomitant medical condition that could put the patient at risk during thestudy.
Had a history of neurological/psychiatric disorders that could interfere with thepatient's participation.
Had systemic immunomodulatory therapies within 12 weeks prior to the baseline visit.
Had prolonged exposure to natural or artificial ultraviolet radiation within 4 weeksof baseline visit.
Had phototherapy (including laser), photo-chemotherapy or systemic AD therapy within 4weeks prior to baseline visit.
Had topical AD therapies in the areas to be treated within 2 weeks prior to thebaseline visit.
Had alcohol abuse in the last 2 years.
Had allergic history to any non-medical ingredients of the study cream.
Were treated with an investigational drug within 1 month of Day 0 or were currentlyparticipating in another trial.
Study Design
Study Description
Connect with a study center
Innovaderm Research Inc.,
Montreal, Quebec H2K 4L5
CanadaSite Not Available

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