Acne ConglobataPhase 2APACCONCT04161456
Preliminary Efficacy and Safety of Apremilast in the Treatment of Acne Conglobata
A Phase 2 study testing Apremilast in people with Acne Conglobata, run by Dr. Frank Behrens at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acne Conglobata
- What is being tested?
- Apremilast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- 9 Oct 2019to 8 Feb 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acne conglobata for a minimum of 6 months
- Active condition of acne conglobata, defined as minimum IGA of 2 (5-point scale) of severity of acne conglobate
- 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
- Written informed consent obtained from the patients prior to the initiation of any protocol-required procedures
- Compliance to study procedures and study protocol
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- Age 18 - 65 years
- patients who do not tolerate or no longer tolerate therapies or for whom the following treatment options are contraindicated:
- Topical retinoid therapy
- isotretinoin and/or acitretin as standard therapy
- Topical treatment with antibiotics, glucocorticoids, retinoids, Vit-D-analogue, calcineurin inhibitors
- systemic antibiotics, systemic glucocorticoids
- systemic retinoids
Who cannot join
- Previous use of Apremilast, or any other PDE-4 inhibitor
- According to Summary of Product characteristics (SmPC); see special warnings regarding suicidal ideation and behaviour
- Known hypersensitivity to any component of the investigator medicinal product (IMP)
- Current use of strong CYP3A4 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin, and St. John's Wort) 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, ichthyosis, 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:
Show all 31Show fewer
- Medication related acne (e.g., steroid abuse)
- Acne with facial edema
- Recalcitrant acne
- Acne cosmetic, pomade acne
- Acne mechanica
- Chloracne
- 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 including also strict abstinence, or partner had a vasectomy
- Severe kidney insufficiency (glomerular filtration rate (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) and biologicals
- Current participation in another investigational clinical trial or participation 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)
- History and current status of suicidal thoughts or behaviour or previous suicidal attempt
- Washout times for previous therapy for acne conglobata before screening:
- 1 week for any topical treatment (e.g., antibiotics, glucocorticoids, retinoids, Vit-D-analogue, calcineurin inhibitors)
- 4 weeks for any systemic antibiotics, systemic glucocorticoids or UV-therapy
- 12 weeks for any systemic retinoids or any investigational drug
- Patients who take any kind of contraceptive therapy (eg. estrogen, gestagen) with known positive effect on acne must be on stable dosage for a minimum of 6 month
- Underage or incapable patients
- Patients who are legally institutionalized
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Acne Conglobata
- Being tested
- Apremilast
- Keywords
- Acne conglobata, Phosphodiesterase (PDE)-Inhibitor
- Medical subject headings
- Acne Conglobata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Also called Otezla
Apremilast twice daily 30 mg
| Study group | Role | What they receive |
|---|---|---|
| Apremilast | Experimental | Apremilast twice daily 30 mg Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
50% reduction in number of lesion
proportion of subjects who achieve at least a 50% reduction in total number of inflammatory lesions
Measured: 24 weeks
Secondary outcomes (47)
Proportionof subjects in Investigator global assessment (IGA)
proportion of subjects who achieve an IGA 0 / 1 or an improvement of a minimum 2 points on an IGA 5-point scale (value 0 to 4, whereby 0 is symptom-free and 4 severe symptoms)
Measured: Baseline to visit 3 (week 2)
proportion of subjects in Investigator global assessment (IGA)
proportion of subjects who achieve an IGA 0 / 1 or an improvement of a minimum 2 points on an IGA 5-point scale (value 0 to 4, whereby 0 is symptom-free and 4 severe symptoms)
Measured: Baseline to visit 4 (week 4)
proportion of subjects in Investigator global assessment (IGA)
proportion of subjects who achieve an IGA 0 / 1 or an improvement of a minimum 2 points on an IGA 5-point scale (value 0 to 4, whereby 0 is symptom-free and 4 severe symptoms)
Measured: Baseline to visit 5 (week 8)
proportion of subjects in Investigator global assessment (IGA)
proportion of subjects who achieve an IGA 0 / 1 or an improvement of a minimum 2 points on an IGA 5-point scale (value 0 to 4, whereby 0 is symptom-free and 4 severe symptoms)
Measured: Baseline to visit 6 (week 16)
proportion of subjects in Investigator global assessment (IGA)
proportion of subjects who achieve an IGA 0 / 1 or an improvement of a minimum 2 points on an IGA 5-point scale (value 0 to 4, whereby 0 is symptom-free and 4 severe symptoms)
Measured: Baseline to visit 7 (week 24)
change in skin condition
skin condition measured in Symptoms Score REduction Index (SSRI), calculated as the percentage of lesions after treatment in relation to before treatment. The lower the value the more reduction of lesions was achieved by treatment
Measured: at visit 3 (week 2)
change in skin condition
skin condition measured in Symptoms Score REduction Index (SSRI)calculated as the percentage of lesions after treatment in relation to before treatment. The lower the value the more reduction of lesions was achieved by treatment
Measured: at visit 4 (week 4)
change in skin condition
skin condition measured in Symptoms Score Reduction Index (SSRI)calculated as the percentage of lesions after treatment in relation to before treatment. The lower the value the more reduction of lesions was achieved by treatment
Measured: at visit 5 (week 8)
change in skin condition
skin condition measured in Symptoms Score Reduction Index (SSRI)calculated as the percentage of lesions after treatment in relation to before treatment. The lower the value the more reduction of lesions was achieved by treatment
Measured: at visit 6 (week 16)
change in skin condition
skin condition measured in Symptoms Score Reduction Index (SSRI)calculated as the percentage of lesions after treatment in relation to before treatment. The lower the value the more reduction of lesions was achieved by treatment
Measured: at visit 7 (week 24)
change in pain of the inflammatory lesions
pain of the inflammatory lesions measured by a visual analog scale (VAS), measured in mm values (0 mm to 100 mm). The higher the value the more pain is experienced by the subject.
Measured: at visit 3 (week 2)
change in pain of the inflammatory lesions
pain of the inflammatory lesions measured by a visual analog scale (VAS)measured in mm values (0 mm to 100 mm). The higher the value the more pain is experienced by the subject.
Measured: at visit 4 (week 4)
change in pain of the inflammatory lesions
pain of the inflammatory lesions measured by a visual analog scale (VAS)measured in mm values (0 mm to 100 mm). The higher the value the more pain is experienced by the subject.
Measured: at visit 5 (week 8)
change in pain of the inflammatory lesions
pain of the inflammatory lesions measured by a visual analog scale (VAS)measured in mm values (0 mm to 100 mm). The higher the value the more pain is experienced by the subject.
Measured: at visit 6 (week 16)
change in pain of the inflammatory lesions
pain of the inflammatory lesions measured by a visual analog scale (VAS)measured in mm values (0 mm to 100 mm). The higher the value the more pain is experienced by the subject.
Measured: at visit 7 (week 24)
change in itch of the inflammatory lesions measured by a VAS
itch of the inflammatory lesions measured by a VAS, measured in mm values (0 mm to 100 mm). The higher the value the more itching is experienced by the subject.
Measured: at visit 3 (week 2)
change in itch of the inflammatory lesions measured by a VAS
itch of the inflammatory lesions measured by a VAS, measured in mm values (0 mm to 100 mm). The higher the value the more itching is experienced by the subject.
Measured: at visit 4 (week 4)
change in itch of the inflammatory lesions measured by a VAS
itch of the inflammatory lesions measured by a VAS, measured in mm values (0 mm to 100 mm). The higher the value the more itching is experienced by the subject.
Measured: at visit 5 (week 8)
change in itch of the inflammatory lesions measured by a VAS
itch of the inflammatory lesions measured by a VAS, measured in mm values (0 mm to 100 mm). The higher the value the more itching is experienced by the subject.
Measured: at visit 6 (week 16)
change in itch of the inflammatory lesions measured by a VAS
itch of the inflammatory lesions measured by a VAS, measured in mm values (0 mm to 100 mm). The higher the value the more itching is experienced by the subject.
Measured: at visit 7 (week 24)
change in quality of life
change in quality of life measured by Dermatology Life Quality Index (DLQI). The DLQI is calculated by summing the score of each of the 10 questions resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Measured: Baseline to visit 3 (week 2)
change in quality of life
change in quality of life measured by Dermatology Life Quality Index (DLQI).The DLQI is calculated by summing the score of each of the 10 questions resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Measured: Baseline to visit 4 (week 4)
change in quality of life
change in quality of life measured by Dermatology Life Quality Index (DLQI). The DLQI is calculated by summing the score of each of the 10 questions resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Measured: Baseline to visit 5 (week 8)
change in quality of life
change in quality of life measured by Dermatology Life Quality Index (DLQI). The DLQI is calculated by summing the score of each of the 10 questions resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Measured: Baseline to visit 6 (week 16)
change in quality of life
change in quality of life measured by Dermatology Life Quality Index (DLQI). The DLQI is calculated by summing the score of each of the 10 questions resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Measured: Baseline to visit 7 (week 24)
change in depression profile
change in depression profile measured by Patient Health Questionnaire (PHQ-9). The PHQ-9 is the 9-item depression module from the full PHQ. As a severity measure, the PHQ-9 score can range from 0 to 27, since each of the 9-items can be scored from 0 (not at all) to 3 (nearly every day).
Measured: Baseline to Visit 3 (week 2)
change in depression profile
change in depression profile measured by Patient Health Questionnaire (PHQ-9). The PHQ-9 is the 9-item depression module from the full PHQ. As a severity measure, the PHQ-9 score can range from 0 to 27, since each of the 9-items can be scored from 0 (not at all) to 3 (nearly every day).
Measured: Baseline to Visit 4 (week 4)
change in depression profile
change in depression profile measured by Patient Health Questionnaire (PHQ-9).The PHQ-9 is the 9-item depression module from the full PHQ. As a severity measure, the PHQ-9 score can range from 0 to 27, since each of the 9-items can be scored from 0 (not at all) to 3 (nearly every day).
Measured: Baseline to Visit 5 (week 8)
change in depression profile
change in depression profile measured by Patient Health Questionnaire (PHQ-9). The PHQ-9 is the 9-item depression module from the full PHQ. As a severity measure, the PHQ-9 score can range from 0 to 27, since each of the 9-items can be scored from 0 (not at all) to 3 (nearly every day).
Measured: Baseline to Visit 6 (week 16)
change in depression profile
change in depression profile measured by Patient Health Questionnaire (PHQ-9). The PHQ-9 is the 9-item depression module from the full PHQ. As a severity measure, the PHQ-9 score can range from 0 to 27, since each of the 9-items can be scored from 0 (not at all) to 3 (nearly every day).
Measured: Baseline to Visit 7 (week 24)
compliance to therapy (drug accountability)
compliance to therapy measured by drug accountability (counting of returned IMP)
Measured: at visit 3 (week 2)
compliance to therapy (drug accountability)
compliance to therapy measured by drug accountability (counting of returned IMP)
Measured: at visit 4 (week 4)
compliance to therapy (drug accountability)
compliance to therapy measured by drug accountability (counting of returned IMP)
Measured: at visit 5 (week 8)
compliance to therapy (drug accountability)
compliance to therapy measured by drug accountability (counting of returned IMP)
Measured: at visit 6 (week 16)
compliance to therapy (drug accountability)
compliance to therapy measured by drug accountability (counting of returned IMP)
Measured: at visit 7 (week 24)
Frequency of adverse events (AEs)
Frequency of adverse events (AEs) as documented in Case Report Form (CRF)
Measured: at visit 3 (week 2)
Frequency of adverse events (AEs)
Frequency of adverse events (AEs) as documented in Case Report Form (CRF)
Measured: at visit 4 (week 4)
Frequency of adverse events (AEs)
Frequency of adverse events (AEs) as documented in Case Report Form (CRF)
Measured: at visit 5 (week 8)
Frequency of adverse events (AEs)
Frequency of adverse events (AEs) as documented in Case Report Form (CRF)
Measured: at visit 6 (week 16)
Frequency of adverse events (AEs)
Frequency of adverse events (AEs) as documented in Case Report Form (CRF)
Measured: at visit 7 (week 24)
Frequency of adverse events (AEs)
Frequency of adverse events (AEs) as documented in Case Report Form (CRF)
Measured: at Follow-up (week 28)
Seriousness of adverse events (AEs)
Determination of seriousness of adverse events (AEs) and rate of seriousness as documented in Case Report Form (CRF)
Measured: at visit 3 (week 2)
Seriousness of adverse events (AEs)
Determination of seriousness of adverse events (AEs) and rate of seriousness as documented in Case Report Form (CRF)
Measured: at visit 4 (week 4)
Seriousness of adverse events (AEs)
Determination of seriousness of adverse events (AEs) and rate of seriousness as documented in Case Report Form (CRF)
Measured: at visit 5 (week 8)
Seriousness of adverse events (AEs)
Determination of seriousness of adverse events (AEs) and rate of seriousness as documented in Case Report Form (CRF)
Measured: at visit 6 (week 18)
Seriousness of adverse events (AEs)
Determination of seriousness of adverse events (AEs) and rate of seriousness as documented in Case Report Form (CRF)
Measured: at visit 7 (week 24)
Seriousness of adverse events (AEs)
Determination of seriousness of adverse events (AEs) and rate of seriousness as documented in Case Report Form (CRF)
Measured: at Follow-up (week 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start9 Oct 2019
- Primary completion8 Feb 2021
- Study completion8 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne ConglobataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will be treated with Apremilast
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Frank Behrens
- Sponsor type
- University, hospital or other
- Collaborators
- Dermatology Department University Hospital Frankfurt, Celgene
- Responsible party
- Sponsor-investigator, Dr. Frank Behrens, Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
- Investigators
- Andreas Pinter, MD, Principal investigator, University Hospital of Goethe-University Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161456
- Sponsor's protocol ID
- TMP-0517
- Acronym
- APACCO
- Status last verified
- Mar 2022
- First submitted
- 5 Nov 2019
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04161456
- Acronym / sponsor ID
- APACCO / TMP-0517
- Conditions
- Acne Conglobata
- Keywords
- Acne conglobata, Phosphodiesterase (PDE)-Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Dr. Frank BehrensUniversity, hospital or other
- Collaborators
- Dermatology Department University Hospital Frankfurt, Celgene
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will be treated with Apremilast
| Arm | Type | Receives |
|---|---|---|
| Apremilast | Experimental | Drug: ApremilastApremilast twice daily 30 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosis of acne conglobata for a minimum of 6 months
- Active condition of acne conglobata, defined as minimum IGA of 2 (5-point scale) of severity of acne conglobate
- 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
- Written informed consent obtained from the patients prior to the initiation of any protocol-required procedures
Key exclusion criteria (31 listed)
- Previous use of Apremilast, or any other PDE-4 inhibitor
- According to Summary of Product characteristics (SmPC); see special warnings regarding suicidal ideation and behaviour
- Known hypersensitivity to any component of the investigator medicinal product (IMP)
- Current use of strong CYP3A4 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin, and St. John's Wort) 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, ichthyosis, 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApremilastAlso: OtezlaApremilast twice daily 30 mg | Drug | Apremilast |
Primary outcome
50% reduction in number of lesion
Time frame: 24 weeks
proportion of subjects who achieve at least a 50% reduction in total number of inflammatory lesions
47 secondary outcomes
Proportionof subjects in Investigator global assessment (IGA)
Time frame: Baseline to visit 3 (week 2)
proportion of subjects in Investigator global assessment (IGA)
Time frame: Baseline to visit 4 (week 4)
proportion of subjects in Investigator global assessment (IGA)
Time frame: Baseline to visit 5 (week 8)
proportion of subjects in Investigator global assessment (IGA)
Time frame: Baseline to visit 6 (week 16)
proportion of subjects in Investigator global assessment (IGA)
Time frame: Baseline to visit 7 (week 24)
change in skin condition
Time frame: at visit 3 (week 2)
change in skin condition
Time frame: at visit 4 (week 4)
change in skin condition
Time frame: at visit 5 (week 8)
change in skin condition
Time frame: at visit 6 (week 16)
change in skin condition
Time frame: at visit 7 (week 24)
change in pain of the inflammatory lesions
Time frame: at visit 3 (week 2)
change in pain of the inflammatory lesions
Time frame: at visit 4 (week 4)
change in pain of the inflammatory lesions
Time frame: at visit 5 (week 8)
change in pain of the inflammatory lesions
Time frame: at visit 6 (week 16)
change in pain of the inflammatory lesions
Time frame: at visit 7 (week 24)
change in itch of the inflammatory lesions measured by a VAS
Time frame: at visit 3 (week 2)
change in itch of the inflammatory lesions measured by a VAS
Time frame: at visit 4 (week 4)
change in itch of the inflammatory lesions measured by a VAS
Time frame: at visit 5 (week 8)
change in itch of the inflammatory lesions measured by a VAS
Time frame: at visit 6 (week 16)
change in itch of the inflammatory lesions measured by a VAS
Time frame: at visit 7 (week 24)
change in quality of life
Time frame: Baseline to visit 3 (week 2)
change in quality of life
Time frame: Baseline to visit 4 (week 4)
change in quality of life
Time frame: Baseline to visit 5 (week 8)
change in quality of life
Time frame: Baseline to visit 6 (week 16)
change in quality of life
Time frame: Baseline to visit 7 (week 24)
change in depression profile
Time frame: Baseline to Visit 3 (week 2)
change in depression profile
Time frame: Baseline to Visit 4 (week 4)
change in depression profile
Time frame: Baseline to Visit 5 (week 8)
change in depression profile
Time frame: Baseline to Visit 6 (week 16)
change in depression profile
Time frame: Baseline to Visit 7 (week 24)
compliance to therapy (drug accountability)
Time frame: at visit 3 (week 2)
compliance to therapy (drug accountability)
Time frame: at visit 4 (week 4)
compliance to therapy (drug accountability)
Time frame: at visit 5 (week 8)
compliance to therapy (drug accountability)
Time frame: at visit 6 (week 16)
compliance to therapy (drug accountability)
Time frame: at visit 7 (week 24)
Frequency of adverse events (AEs)
Time frame: at visit 3 (week 2)
Frequency of adverse events (AEs)
Time frame: at visit 4 (week 4)
Frequency of adverse events (AEs)
Time frame: at visit 5 (week 8)
Frequency of adverse events (AEs)
Time frame: at visit 6 (week 16)
Frequency of adverse events (AEs)
Time frame: at visit 7 (week 24)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Pinter, MD principal investigator
University Hospital of Goethe-University Frankfurt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apremilast in people with Acne Conglobata, run by Dr. Frank Behrens at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
50% reduction in number of lesion (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.