facial acne vulgaris MedDRA version: 18.1 Level: LLT Classification code 10000519 Term: Acne vulgaris System Organ Class: 100000004858
Conditions
Interventions
Product Name: N-Acetyl-GED-0507-34-Levo 1%
Pharmaceutical Form: Gel
INN or Proposed INN: Not yet available.
CAS Number: 1190427-41-8
Current Sponsor code: N-Acetyl-GED-0507-34-Levo
Concentration unit:
Sponsors
PPM Services S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Informed consent and assent: Written informed consent, before any study-related procedure, personally signed and dated by the patient if the patient is = 18 years old, or signed and dated by the parent(s) or the legal guardian if the patient is 14 - =65 years) no F.1.3.1 Number of subjects for this age range ;Inclusion criteria: 1.Informed consent and assent: Written informed consent, before any study-related procedure, personally signed and dated by the patient if the patient is = 18 years old, or signed and dated by the parent(s) or the legal guardian if the patient is 14 - =65 years) no F.1.3.1 Number of subjects for this age range ;Inclusion criteria: 1.Informed consent and assent: Written informed consent, before any study-related procedure, personally signed and dated by the patient if the patient is = 18 years old, or signed and dated by the parent(s) or the legal guardian if the patient is 14 - =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Acne: Patients with spontaneously improving or rapidly deteriorating acne within at least 3 months before screening. Patients who have a known history of acne unresponsive to topical treatments. Patients with generalized or localized severe acne 2.Beard and facial hair: Patients who have a beard or who intend to grow a beard during the study. Subject has facial hair that could interfere with the study assessments in the opinion of the investigator 3.Skin diseases: Subjects with other active skin diseases (e.g. urticaria, atopic dermatitis) or skin infections (bacterial, fungal, or viral) that might interfere with the evaluation of acne, with the exception of footpad trichophytosis (athlete's foot) or common warts 4.Allergy: Known or suspected hypersensitivity to any active or inactive ingredient in the study products. Subjects with a history of an allergic reaction or significant sensitivity to the formulations’ ingredients 5.Topical therapies: Patients using, will use during the study, or discontinued less than 4 weeks before study baseline, prescribed or over-the counter topical therapies for the treatment of acne including but not limited to: corticosteroids, antibiotics, azelaic acid, benzoyl peroxide and retinoids. 6.Phototherapy: Patients using, will use during the study, or discontinued less than 12 weeks before study baseline, phototherapy for the treatment of acne including but not limited to: UV-A, UV-B, heliotherapy. Patients have the need or plan to be exposed to artificial tanning devices or excessive sunlight during the trial 7.Systemic therapies: Patients using, will use during the study, or discontinued less than 12 weeks before study baseline, systemic therapies for the treatment of acne including but not limited to: antibiotics, isotretinoin. Other systemic therapy which, in the opinion of the investigator, could affect the subject’s acne (Women on hormonal acne therapy can be enrolled if they have been on the hormonal therapy for at least 3 months before the screening visit and are anticipated to continue the hormonal therapy during the entire study). 8.Investigative studies: Participation in the evaluation of any investigational product or device within 30 days before study baseline 9.Diseases: Subject with underlying conditions (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator could significantly immunocompromise the subject and/or place the subject at an unacceptable risk to receiving an immunomodulatory therapy. Any condition which in the investigator’s opinion would make it unsafe for the subject to participate in the study. Patients with Polycystic ovary syndrome 10.Alcohol and other substance abuse: History of alcohol or other substance abuse within one year before screening 11.Communication: Subject and parent/guardian (if applicable) unable to communicate or cooperate with the investigator due to e.g. language problems, impaired cerebral function, bad mental conditions 12.Reliability: Subject who may be unreliable for the study including subjects who are unable to return for the scheduled visits 13.Pregnancy (females only): Pregnant or breastfeeding women or planning to become pregnant during the study. ;Exclusion criteria: 1.Acne: Patients with spontaneously improving or rapidly deteriorating acne within at least 3 months before screening. Patients who have a known history of acne unresponsive to topical treatments. Patients with generalized or localized severe acne 2.Beard and facial hair: Patients who have a beard or who intend to grow a beard during the study. Subject has facial hair that could interfere with the study assessments in the opinion of the investigator 3.Skin diseases: Subjects with other active skin diseases (e.g. urticaria, atopic dermatitis) or skin infections (bacterial, fungal, or viral) that might interfere with the evaluation of acne, with the exception of footpad trichophytosis (athlete's foot) or common warts 4.Allergy: Known or suspected hypersensitivity to any active or inactive ingredient in the study products. Subjects with a history of an allergic reaction or significant sensitivity to the formulations’ ingredients 5.Topical therapies: Patients using, will use during the study, or discontinued less than 4 weeks before study baseline, prescribed or over-the counter topical therapies for the treatment of acne including but not limited to: corticosteroids, antibiotics, azelaic acid, benzoyl peroxide and retinoids. 6.Phototherapy: Patients using, will use during the study, or discontinued less than 12 weeks before study baseline, phototherapy for the treatment of acne including but not limited to: UV-A, UV-B, heliotherapy. Patients have the need or plan to be exposed to artificial tanning devices or excessive sunlight during the trial 7.Systemic therapies: Patients using, will use during the study, or discontinued less than 12 weeks before study baseline, systemic therapies for the treatment of acne including but not limited to: antibiotics, isotretinoin. Other systemic therapy which, in the opinion of the investigator, could affect the subject’s acne (Women on hormonal acne therapy can be enrolled if they have been on the hormonal therapy for at least 3 months before the screening visit and are anticipated to continue the hormonal therapy during the entire study). 8.Investigative studies: Participation in the evaluation of any investigational product or device within 30 days before study baseline 9.Diseases: Subject with underlying conditions (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator could significantly immunocompromise the subject and/or place the subject at an unacceptable risk to receiving an immunomodulatory therapy. Any condition which in the investigator’s opinion would make it unsafe for the subject to participate in the study. Patients with Polycystic ovary syndrome 10.Alcohol and other substance abuse: History of alcohol or other substance abuse within one year before screening 11.Communication: Subject and parent/guardian (if applicable) unable to communicate or cooperate with the investigator due to e.g. language problems, impaired cerebral function, bad mental conditions 12.Reliability: Subject who may be unreliable for the study including subjects who are unable to return for the scheduled visits 13.Pregnancy (females only): Pregnant or breastfeeding women or planning to become pregnant during the study. ;Exclusion criteria: 1.Acne: Patients with spontaneously improving or rapidly deteriorating acne within at least 3 months before screening. Patients who have a known history of acne unresponsive to topical treatments. Patients with generalized or localized severe acne 2.Beard and facial hair: Patients who have a beard or who intend to grow a beard during the study. Subject has facial hair that could interfere with the study assessments in the opinion of the investigator 3.Skin diseases: Subjects with other active skin diseases (e.g. urticaria, atopic dermatitis) or skin infections (bacterial, fungal, or viral) that might interfere with the evaluation of acne, with the exception of footpad trichophytosis (athlete's foot) or common warts 4.Allergy: Known or suspected hypersensitivity to any active or inactive ingredient in the study products. Subjects with a history of an allergic reaction or significant sensitivity to the formulations’ ingredients 5.Topical therapies: Patients using, will use during the study, or discontinued less than 4 weeks before study baseline, prescribed or over-the counter topical therapies for the treatment of acne including but not limited to: corticosteroids, antibiotics, azelaic acid, benzoyl peroxide and retinoids. 6.Phototherapy: Patients using, will use during the study, or discontinued less than 12 weeks before study baseline, phototherapy for the treatment of acne including but not limited to: UV-A, UV-B, heliotherapy. Patients have the need or plan to be exposed to artificial tanning devices or excessive sunlight during the trial 7.Systemic therapies: Patients using, will use during the study, or discontinued less than 12 weeks before study baseline, systemic therapies for the treatment of acne including but not limited to: antibiotics, isotretinoin. Other systemic therapy which, in the opinion of the investigator, could affect the subject’s acne (Women on hormonal acne therapy can be enrolled if they have been on the hormonal therapy for at least 3 months before the screening visit and are anticipated to continue the hormonal therapy during the entire study). 8.Investigative studies: Participation in the evaluation of any investigational product or device within 30 days before study baseline 9.Diseases: Subject with underlying conditions (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator could significantly immunocompromise the subject and/or place the subject at an unacceptable risk to receiving an immunomodulatory therapy. Any condition which in the investigator’s opinion would make it unsafe for the subject to participate in the study. Patients with Polycystic ovary syndrome 10.Alcohol and other substance abuse: History of alcohol or other substance abuse within one year before screening 11.Communication: Subject and parent/guardian (if applicable) unable to communicate or cooperate with the investigator due to e.g. language problems, impaired cerebral function, bad mental conditions 12.Reliability: Subject who may be unreliable for the study including subjects who are unable to return for the scheduled visits 13.Pregnancy (females only): Pregnant or breastfeeding women or planning to become pregnant during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to evaluate the efficacy and the local and systemic safety of 1% and 2% N-Acetyl-GED-0507-34-Levo gel, in comparison to the matching placebo gel, applied once daily for 12 weeks in patients with mild to moderate facial acne vulgaris;Secondary Objective: Not applicable;Primary end point(s): Percentage of change from baseline in inflammatory lesions at week 12;Timepoint(s) of evaluation of this end point: 12 weeks;Main Objective: The objective of the study is to evaluate the efficacy and the local and systemic safety of 1% and 2% N-Acetyl-GED-0507-34-Levo gel, in comparison to the matching placebo gel, applied once daily for 12 weeks in patients with mild to moderate facial acne vulgaris;Secondary Objective: Not applicable;Primary end point(s): Percentage of change from baseline in inflammatory lesions at week 12;Timepoint(s) of evaluation of this end point: 12 weeks;Main Objective: The objective of the study is to evaluate the efficacy and the local and systemic safety of 1% and 2% N-Acetyl-GED-0507-34-Levo gel, in comparison to the matching placebo gel, applied once daily for 12 weeks in patients with mild to moderate facial acne vulgaris;Secondary Objective: Not applicable;Primary end point(s): Percentage of change from baseline in inflammatory lesions at week 12;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Absolute change from baseline in inflammatory lesions at week 12 2) Change from baseline (absolute and percentage) in inflammatory lesions at the other post-baseline assessment times 3) Change from baseline (absolute and percentage) in non-inflammatory lesions and total lesions (inflammatory plus non-inflammatory) at week 12 and at the other post-baseline assessment times 4) Proportion of subjects with an Investigator’s Global Assessment (IGA) score of “clear” (score=0) or “almost clear” (score=1) AND at least a two-score point reduction in IGA compared to baseline at week 12 and at the other post-baseline assessment times 5) Evaluation of safety, tolerability and local tolerability of the test treatments as compared to the matching placebo. ;Timepoint(s) of evaluation of this end point: 12 weeks;Secondary end point(s): 1) Absolute change from baseline in inflammatory lesions at week 12 2) Change from baseline (absolute and percentage) in inflammatory lesions at the other post-baseline assessment times 3) Change from baseline (absolute and percentage) in non-inflammatory lesions and total lesions (inflammatory plus non-inflammatory) at week 12 and at the other post-baseline assessment times 4) Proportion of subjects with an Investigator’s Global Assessment (IGA) score of “clear” (score=0) or “almost clear” (score=1) AND at least a two-score point reduction in IGA compared to baseline at week 12 and at the other post-baseline assessment times 5) Evaluation of safety, tolerability and local tolerability of the test treatments as compared to the matching placebo. ;Timepoint(s) of evaluation of this end point: 12 weeks;Secondary end point(s): 1) Absolute change from baseline in inflammatory lesions at week 12 2) Change from baseline (absolute and percentage) in inflammatory lesions at the other post-baseline assessment times 3) Change from baseline (absolute and percentage) in non-inflammatory lesions and total lesions (inflammatory plus non-i | — |
Countries
Hungary
Contacts
Public ContactAngelo Vaccani;Angelo Vaccani;Angelo Vaccani ;;
CROSS Reserach;CROSS Reserach;CROSS Reserach
Outcome results
None listed