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軽度から中等度のアトピー性皮膚炎または軽度から重度の尋常性乾癬の患者を対象とした、治験薬(PF-07038124)について学ぶための研究。

基本情報

NCT ID
NCT05375955
ステータス
完了
試験のフェーズ
第2相
試験タイプ
介入
目標被験者数
263
治験依頼者名
Pfizer

概要

The purpose of this clinical trial is to learn about the safety, how well the study medicine works, extent to which side effects can be tolerated, and how the study medicine is changed and eliminated from your body after you apply it on your skin. The study medicine is in ointment form. This study is seeking participants who If they have Atopic Dermatitis (AD): * Have a diagnosis for at least 3 months * Have a diagnosis of mild or moderate disease assessed using Investigator's Global Assessment (IGA) * Have percent Body Surface Area (%BSA) covering 5% up to 40% * A Peak Pruritus Numerical Rating Scale (PP-NRS) average score of ≥2 during the screening period If they have plaque psoriasis (PsO): * Have a diagnosis for at least 6 months * Have a diagnosis of mild, moderate, or severe disease assessed using Physician's Global Assessment (PGA) * Have percent Body Surface Area (%BSA) covering 2% up to 20% All participants in this study will receive either 0.01% PF-07038124, 0.03% PF-07038124, or a vehicle ointment. In addition, some participants with PsO will receive 0.06% PF- PF-07038124. Participants will not know which dose level they have received. The participants will be randomly assigned to each dose group. PF-07038124 ointment will be applied topically to affected areas once daily. We will compare the experiences of people receiving the different dose levels of the ointment to those who receive the vehicle ointment. This will help us determine if PF-07038124 ointment is safe and effective. Participants will take part in this study for approximately 21 weeks. Participants will apply the study medicine once daily for 12 weeks followed by a safety follow-up period of 4-5 weeks from last application of study medicine to last visit.

対象疾患

Atopic DermatitisPlaque Psoriasis

介入

PF-07038124 ointment 0.01%(DRUG)
Vehicle ointment(DRUG)
PF-07038124 ointment 0.03%(DRUG)
PF-07038124 ointment 0.06%(DRUG)

依頼者(Sponsor)

実施施設 (4)

コアラ皮膚科・美容皮膚科クリニック三軒茶屋

Kobe, Hyōgo, Japan

たかぎ皮膚科クリニック

Obihiro, Hokkaido, Japan

産科・婦人科 久米クリニック

Sakai, Osaka, Japan

高木耳鼻咽喉科

Obihiro, Hokkaido, Japan