Mild to severe Acne conglobata in adults (ages 18 to 65 years, inclusive) MedDRA version: 20.0 Level: PT Classification code 10000501 Term: Acne conglobata System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Fraunhofer Gesellschaft for its Institute Fraunhofer Institute for Molecular Biology and Applied Ecology (IME)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the proportion of subjects who achieve at least a 50% reduction in total number of inflammatory lesions at week 24;Secondary Objective: The secondary objectives of the study are •To evaluate the IGA (Investigator’s Global Assessment) of acne severity •To evaluate the improvement of skin condition measured in SSRI (Symptoms Score Reduction Index) •To evaluate the effect of Apremilast in reduction of pain and itch of the inflammatory lesions measured by the visual analogue scale (VAS) of pain and itch •To evaluate lesion check, number of inflammatory lesions •Assessment of quality of life (QoL) by using DLQI •Assessment of depression profile by using PHQ9 •To evaluate compliance (drug accountability) ;Primary end point(s): Primary efficacy: •Determination of proportion of subjects who achieve at least a 50% reduction in total number of inflammatory lesions at week 24 compared to baseline ;Timepoint(s) of evaluation of this end point: Primary efficacy: •At week 24 compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy: Determination of •the proportion of subjects who achieve an IGA 0 / 1 or an improvement of a minimum 2 points on an IGA 5-point scale •change in skin condition measured in SSRI •change in pain and itch of the inflammatory lesions measured by a VAS •change in quality of life measured by DLQI •change in depression profile measured by PHQ-9 •change in compliance (drug accountability) as indicated in flow chart. Overall safety parameters: •Frequency and seriousness of adverse events (AEs) (as detailed under Protocol Version 2.0 dated 20. May 2019) ;Timepoint(s) of evaluation of this end point: The entire assessments will be done on week 0 (visit 2), week 2 (visit 3), week 4 (visit 4), week 8 (visit 5), week 16 (visit 6) and week 24 (visit 7). | — |
Countries
Germany
Contacts
Public ContactProject Group TMP
Fraunhofer IME, Clinical Research
Outcome results
None listed