facial acne vulgaris MedDRA version: 20.0 Level: PT Classification code 10000496 Term: Acne System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
PPM SERVICES S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained. 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 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Patients with spontaneously improving or rapidly deteriorating acne within at least 3 months before study baseline. Patients who have a known history of acne unresponsive to topical and/or oral treatments. In particular subjects with history of persistent acne (a continuation of the disease from adolescence into adulthood) and subjects with history of relapsing acne. Patients with generalized or localized acne forms other than acne vulgaris, e.g., acne conglobata, acne fulminans, acne rosacea, secondary acne (chloracne, drug-induced acne, etc), nodule-cystic acne, acne tarda or acne requiring systemic treatment. 2.Patients who have a beard or who intend to grow a beard and/or to perform a facial tattoo during the study. Patient has facial hair or facial tattoos that could interfere with the study assessments in the opinion of the investigator. 3. Patients with other active skin diseases (e.g., urticaria, atopic dermatitis, sunburn, seborrheic dermatitis, perioral dermatitis, rosacea, skin malignancies) or active skin infections in the facial region (bacterial, fungal, or viral) or any other facial disease or condition that might interfere with the evaluation of acne or place the patient at unacceptable risk. 4. Known or suspected hypersensitivity to any active or inactive ingredient in the study products. Patients with a history of an allergic reaction or significant sensitivity to the formulations’ ingredients 5. 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 salicylates, a-hydroxy/glycolic acid, any other topical cosmetic therapy for acne and retinoids on the face. 6. Patients using, will use during the study, or discontinued less than 4 weeks before study baseline, facial application of products containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non-mild cleansers or moisturizers containing retinol, salicylic or alpha- or beta-hydroxy acids, facial procedures such as chemical peel, laser treatment, photodynamic therapy, acne surgery, cryodestruction or chemodestruction, x-ray therapy, intralesional steroids, dermabrasion, or depilation (except eyebrow shaping). 7. 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 who have the need or plan to be exposed to artificial tanning devices or excessive sunlight during the study. 8. 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 patient’s acne (i.e., anabolics, lithium, EGRF inhibitors, iodides, systemic corticosteroids or other immunosuppressants). 9. Known systemic diseases that can lead to acneiform eruptions: a. Increased androgen production. 1) Adrenal origin: e.g., Cushing’s disease, 21-hydroxylase deficiency; 2) Ovarian origin: e.g., polycystic ovarian syndrome, ovarian hyperthecosis b. Cryptococcosis disseminated c. Dimorphic fungal infections. 10. Participation in the evaluation of any investigational produc
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 2% and 5% N-Acetyl-GED-0507-34-Levo gel, in comparison to the corresponding vehicle gel, applied once daily (OD) for 12 weeks in patients with facial acne vulgaris;Secondary Objective: The objective of the study is to evaluate the efficacy and the local and systemic safety of 2% and 5% N-Acetyl-GED-0507-34-Levo gel, in comparison to the corresponding vehicle gel, applied once daily (OD) for 12 weeks in patients with facial acne vulgaris;Primary end point(s): Two primary efficacy endpoints: To demonstrate the efficacy of a 12 weeks treatment with 5% N-Acetyl-GED-0507-34-Levo gel, the following family of primary efficacy endpoints will be analyzed: 1. Endpoint 1 (E1): the percent change from baseline in total lesion count (inflammatory plus non-inflammatory) at V6/Wk12. 2. Endpoint 2 (E2): proportion of patients with an IGA success defined as score of “clear” (score = 0) or “almost clear” (score = 1) and at least a 2-score point reduction in IGA at V6/Wk12. The assessment of E1 and E2 will be performed according to the hierarchical order above (chosen according to each endpoint clinical relevance), i.e. success on endpoint E1 will permit analysis of E2.;Timepoint(s) of evaluation of this end point: V6/W12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2. To demonstrate the efficacy of a 12 weeks treatment with both 2% and 5% N-Acetyl- GED-0507-34-Levo on the following parameters: a. Absolute change from baseline in total lesion count at V6/Wk12. b. Percent (%) change from baseline in inflammatory lesion count at V6/W12. c. Percent (%) change from baseline in non-inflammatory lesion count at V6/W12. d. Absolute change from baseline in inflammatory lesion count at V6/Wk12. e. Absolute change from baseline in non-inflammatory lesion count at V6/Wk12. f. Percent (%) change from baseline in total lesion count at each post-baseline visit. g. Percent (%) change from baseline in inflammatory lesion count at the other postbaseline assessment times. h. Percent (%) change from baseline in non-inflammatory lesion count at the other post-baseline assessment times. i. Proportion of patients with an IGA success defined as score of “clear” (score = 0) or “almost clear” (score = 1) and at least a 2-score point reduction in IGA at the other post-baseline assessment times. j. Absolute change from baseline in total lesion count (inflammatory plus non-inflammatory) at the other post-baseline visits. k. Absolute change from baseline in inflammatory and non-inflammatory lesion count separately at the other post-baseline assessments.;Timepoint(s) of evaluation of this end point: V6/W12 and the other post-baseline assessment times as described in details in E.5.2 section | — |
Countries
Germany, Italy, Poland
Contacts
Public ContactGLOBAL PROJECT MANAGER
HIPPOCRATES RESEARCH SRL
Outcome results
None listed