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)

Phase 1

• Conditions: Mild to severe Acne conglobata in adults (ages 18 to 65 years, inclusive); MedDRA version: 20.0Level: PTClassification code 10000501Term: Acne conglobataSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-002612-14-DE
• Lead Sponsor: Fraunhofer Gesellschaft for its Institute Fraunhofer Institute for Molecular Biology and Applied Ecology (IME)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-15
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Main inclusion criteria
•Diagnosis of acne conglobata for a minimum of 6 months
•Active condition of acne conglobata
•No clinical significant or severe abnormality of skin (e.g. scars, other severe skin disease) based on medical/medication history or physical examination as determined by the treating physician
•Number of abscesses = 2
•Minimum IGA of 2 (5-point scale) of severity of acne conglobata
•Written informed consent obtained from the patients prior to the initiation of any protocol-required procedures
•Compliance to study procedures and study protocol
•Age 18 – 65 years

Main inclusion criteria related to prior treatments:
•patients who do not tolerate or no longer tolerate therapies or for whom the following treatment options are contraindicated:
oTopical retinoid therapy
oIsotretionin and/or acitretin as standard therapy
oTopical treatment with antibiotics, glucocorticoids, retinoids, Vit-D-analogue, calcineurin inhibitors
osystemic antibiotics, systemic glucocorticoids
osystemic retinoids

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Main exclusion criteria
•Previous use of Apremilast, or any other PDE-4 inhibitor.

Exclusion criteria related to IMP
•According to SmPC
•Known hypersensitivity to any component of the IMP
•Current use of strong CYP3A4 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin, and St. John’s Wort)

Exclusion criteria related to general health
•Active dermatologic conditions which may confound the diagnosis of acne conglobata or would interfere with the assessment of treatment (e.g., acne inversa, atopic dermatitis, seborrheic dermatitis, ichtyosis, and psoriasis)
•History of clinically significant infection within the last 4 weeks before screening, which, in the opinion of the treating physician, may compromise the safety of the patient
•Presentation of special type of acne, including but not limited to:
oMedication related acne (e.g., steroid abuse)
oAcne with facial edema
oRecalcitrant acne
oAcne cosmetic, pomade acne
oAcne mechanica
oChloracne
•History of any kind of cancer or carcinoma in situ within the last 5 years before screening
•History of chronic alcohol/drug abuse within the last 12 months before screening
•Pregnant or breastfeeding women
•Females of childbearing potential not willing to use effective contraception (defined as PEARL index <1 - e.g. hormonal contraceptive containing estrogen and progesterone, or progesterone only, applied orally, intravaginal, transdermal or to be injected, IUD) for the duration of the study, strict abstinence, or partner had a vasectomy
•Severe kidney insufficiency (GFR < 30 ml/min)
•Any severe disease, which, in the opinion of the treating physician, may interfere or worsen the acne conglobata or could become a safety problem for patients
•History of or current Hepatitis-B, Hepatitis-C or HIV infection
•Any active medication which suppresses the immune system, including disease modifying anti-rheumatic drugs (DMARDs)
•Current participation in another investigational clinical trial or participation in another investigational clinical trial within 30 days prior to screening
•Major surgery within the last 4 weeks before screening
•Subject susceptible to take a local corticosteroid treatment (class I – III) during the study except inhaled or topic when needed to treat a condition outside the treatment area (head, neck, upper trunk)

Exclusion criteria related to prior treatments:
•Washout times for previous therapy for acne conglobata before screening:
o1 week for any topical treatment (e.g., antibiotics, glucocorticoids, retinoids, Vit-D-analogue, calcineurin inhibitors)
o4 weeks for any systemic antibiotics, systemic glucocorticoids or UV-therapy
o12 weeks for any systemic retinoids or any investigational drug
oPatients who take any kind of contraceptive therapy (eg. estrogene, gestagene) with known positive effect on acne must be on stable dosage for a minimum of 6 month

Exclusion criteria related to formal aspects:
•Underage or incapable patients
•Patients who are legally institutionalized

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified