Back to Results
First PageMeta Content
Pharmaceutical sciences / Calcipotriol / Topical / Medicine / Pharmacology / Psoriasis


N22-185S018 Calcipotriene and Betamethasone dipropionate Statistical PREA
Add to Reading List

Open Document

File Size: 563,80 KB

Share Result on Facebook

City

Reference / /

Company

LEO Pharma Inc. / Least 1 AE / the AEs / /

Country

France / United States / Canada / United Kingdom / /

Event

FDA Phase / /

IndustryTerm

final amended protocol / applied study product / drug product / pediatric age / Treatment of psoriasis / study product / draft protocols / topical solution / /

MedicalCondition

lesions Erythema / severe psoriasis / disease / hyperpigmentation / plaque psoriasis / Erythema / Cardiac flutter Conjunctivitis / pain / controlled disease / scalp psoriasis / psoriasis / Joint dislocation Ligament sprain Malaise Myalgia Nasal congestion Nausea Nystagmus Otitis / allergic Dermatitis acneiform Dyspnoea Fatigue Gastroenteritis / /

Organization

U.S. Department of Health and Human Services / Standard Biometrics Division / Translational Sciences Office / Division of Dermatology and Dental Products Clinical Team / Division of Dermatology / Food and Drug Administration Center for Drug Evaluation / Research Office / Medical Division / /

Person

Dawn Williams / Gordana Diglisic / Matthew Guerra / Concurring Reviewers / Melinda McCord / Mohamed Alosh / /

Position

Investigator / Project Manager / M.D. Project Manager / /

Product

Taclonex / Topical Suspension / calcipotriene / betamethasone dipropionate / AEs Reported / Topical / Taclonex® Topical Suspension / MBL-0801 / /

ProvinceOrState

Indiana / /

Technology

amended protocol / following 2 draft protocols / final amended protocol / /

SocialTag