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

Sponsor
Dr. Frank Behrens
Study ID
NCT04161456
Phase
PHASE2
Status
Completed

Conditions

  • Acne Conglobata

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Nov 13, 2019
Start date
Oct 9, 2019
Status verified
Mar 2022
Primary completion
Feb 8, 2021
Completion
Feb 8, 2021

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apremilast
    Apremilast twice daily 30 mg

Primary Outcome Measure

50% reduction in number of lesion [ Time Frame: 24 weeks ]