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Arcutis Biotherapeutics (ARQT)
NASDAQ:ARQT
Arq-151 Cream 0.05%
Atopic Dermatitis (Eczema)
Phase II
Recruiting
Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis
May 05, 2025
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Vehicle Foam, Roflumilast Foam 0.3%
Scalp Psoriasis
Phase III
Completed
Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)
Aug 25, 2021
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Vehicle Foam, Roflumilast Foam
Seborrheic Dermatitis
Phase III
Completed
Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)
Jul 13, 2021
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Arq-151 Active, Arq-151 Vehicle
Atopic Dermatitis Eczema
Phase III
Completed
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)
Apr 11, 2021
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Arq-252 Cream 0.3%, Arq-252 Vehicle Cream, Nb-Uvb Phototherapy Active Treatment, Nb-Uvb Phototherapy Sham Treatment
Vitiligo
Phase II
Terminated
Safety and Efficacy of ARQ-252 Cream 0.3% in Subjects With Non-Segmental Facial Vitiligo
Mar 18, 2021
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Arq-151 Cream 0.15% Or Arq-151 Cream 0.05%
Atopic Dermatitis Eczema
Phase III
Completed
Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis
Mar 16, 2021
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Vehicle Cream, Roflumilast Cream 0.15%
Atopic Dermatitis Eczema
Phase III
Completed
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis
Feb 24, 2021
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Roflumilast Cream, Vehicle Cream
Atopic Dermatitis Eczema
Phase III
Completed
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)
Feb 24, 2021
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Arq-151 Cream 0.3%
Psoriasis, Plaque Psoriasis
Phase II
Completed
Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-216)
Feb 05, 2021
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Arq-151 Cream 0.3%
Psoriasis, Plaque Psoriasis
Phase II
Completed
Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-215)
Nov 30, 2020
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Arcutis Biotherapeutics (ARQT) have in its pipeline
ARQT is currently developing the following drugs: Arq-151 Cream 0.05%, Vehicle Foam, Roflumilast Foam 0.3%, Vehicle Foam, Roflumilast Foam. These drug candidates are in various stages of clinical development as the company works toward FDA approval.