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Preliminary Efficacy and Safety of Apremilast in the Treatment of Acne Conglobata

NCT04161456 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-03-02

No results posted yet for this study

Summary

Apremilast mediates its clinical effect through the cAMP-PKA-NFkappaB pathway which results in a clinical picture changes to a decrease of all signs of inflammation.

Due to the NFkappaB mediated chronical inflammation in the pathogenesis of acne conglobata, a treatment with Apremilast seems to be an effective option.

In this study, treatment with Apremilast (Otezla®) will be performed in patients with acne conglobata to observe its preliminary efficacy and safety in an open label, single-centre proof of concept study design.

Conditions

  • Acne Conglobata

Interventions

DRUG

Apremilast

Apremilast twice daily 30 mg

Sponsors & Collaborators

  • Dermatology Department University Hospital Frankfurt

    collaborator UNKNOWN

  • Celgene

    collaborator INDUSTRY

  • Dr. Frank Behrens

    lead OTHER

Principal Investigators

  • Andreas Pinter, MD · University Hospital of Goethe-University Frankfurt

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-09
Primary Completion
2021-02-08
Completion
2021-02-08

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04161456 on ClinicalTrials.gov