Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-01 @ 9:21 PM
Study NCT ID:
NCT04161456
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2019-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preliminary Efficacy and Safety of Apremilast in the Treatment of Acne Conglobata
Sponsor:
Dr. Frank Behrens
Organization:
Study Overview
Official Title:
Preliminary Efficacy and Safety of Apremilast in the Treatment of Acne Conglobata: A Phase II, Single Centre, Open Label, Proof of Concept Study for the Treatment of Acne Conglobata With the PDE-4 Inhibitor Apremilast (APACCO-Study)
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APACCO
Brief 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.
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.
Detailed Description:
Treatment options for acne conglobata are limited and those which are effective can only be used in short term such as systemic steroids, antibiotics or retinoids due to their association to side effects or potentially teratogenetic effects.
Apremilast, a specific inhibitor for PDE-4, mediates its clinical effect through the cAMP-PKA-NFkappaB pathway which results in a decrease of pro-inflammatory and increase of anti-inflammatory cytokines in several types of leukocytes. The 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.
Apremilast, a specific inhibitor for PDE-4, mediates its clinical effect through the cAMP-PKA-NFkappaB pathway which results in a decrease of pro-inflammatory and increase of anti-inflammatory cytokines in several types of leukocytes. The 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: