Acne vulgaris Skin and Connective Tissue Diseases
Conditions
Interventions
IMP: N-Acetyl-GED-0507-34-Levo 5% gel (5 mg/100 mg)
Each patient will apply a bean-sized amount of gel as a thin film, once daily (OD), to the entire facial skin area and the affected skin areas of t
0 or 3 months in the Phase 3 pivotal study [blinded assignment to IMP or placebo] and an additional 9 months in this open-label long-term extension study).
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 parents or the legal guardian(s) if the patient is =9 to< 18 years old. An additional informed assent form must be signed by the patient if =9 to <18 years old to confirm his willingness to participate in the study. If the patient becomes 18 years of age during the study, the patient must provide written informed consent at that time to continue study participation. 2. Sex and age: Male and female patients aged =9 and <50 years. Patients who turn 50 during the pivotal study can roll over to the LT study. 3. Diagnosis at screening and baseline visits: 3.1. Patients affected by facial acne vulgaris with an Investigator’s Global Assessment (IGA) score: =1 or 2 for pivotal-naïve* patients not included in pivotal 12 Week treatment studies =0 for patients completing the treatment period of pivotal Phase 3 trials (NAC-GED-0507-ACN-01-23-A and NAC-GED-0507-ACN-01-23-B) 3.2. Patients affected by truncal acne (optional criteria) on areas of the trunk (shoulders, upper back and upper anterior chest) accessible for patient’s self-application of study medication with a Physician Global Assessment (PGA) severity grade: =1 or 2 for pivotal-naïve* patients not included in the pivotal 12Week treatment studies =0 and <4 for patients completing the treatment period of pivotal Phase 3 trials (NAC-GED-0507-ACN-01-23-A and NAC-GED-0507-ACN-01-23-B)*Pivotal-naïve: Patients not rolling over from NAC-GED-0507-ACN-01-23-A and NAC-GED-0507-ACN-01-23-B. If the pivotal-naïve patient is = 9 and = 14 years old and declined participation to the pivotal Phase 3 study, a 12-week period should run before inclusion in the present study. 4. Full comprehension Patients and their parents/legal guardian(s) (for <18 years old patients) can comprehend the whole nature and purpose of the study, including possible risks and side effects, and are able to cooperate with the Investigator and to comply with the requirements of the entire study. 5. Contraception and fertility: Women of childbearing potential must be using an effective contraception method during the entire duration of the study. Effective contraception methods are those considered at least“acceptable” according to CTFG Recommendations. A prior stable treatment period is required for the following reliable methods of contraception: 5.1. Hormonal oral, implantable, transdermal, or injectable contraceptives must be stable for at least 6 months before the screening visit 5.2. A non-hormonal intrauterine device (IUD) must be started at least 2 months before the screening visit.
Exclusion criteria
Exclusion criteria: 1. Acne: 1.1. 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 1.2. Patients with acne requiring systemic treatment 2. Beard and facial/body hair, tattoos: 2.1. Patients with a beard or who intend to grow a beard and/or to perform a facial tattoo during the study 2.2. Patients with facial hair or facial tattoos that could interfere with study assessments in the investigator’s opinion 2.3. For patients with truncal acne: body hair, tattoos (or who intend to perform them) on the shoulders, upper back/upper anterior chest accessible to self-application of study medication by the patient (evaluable area) that may interfere with study assessments in investigator’s opinion. 3. Skin diseases: 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 or truncal region (bacterial, fungal, or viral) or any other facial or truncal disease or condition that might interfere with evaluation of acne or place the patient at unacceptable risk 4. Allergy: Known or suspected hypersensitivity to any active or inactive ingredient in the study medication. Patients with a history of an allergic reaction or significant sensitivity to the formulations’ ingredients. 5. Topical therapies: Patients who are currently using, plan to use during the study, or discontinued less than 4 weeks before study baseline the use of prescribed or over-the-counter topical therapies for the treatm. 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/trunk. 6. Topical skin care products and procedures: Patients who are currently using, plan to use during the study, or discontinued less than 4 weeks before study baseline the use of products for facial/truncal application 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/truncal procedures such as chemical peel, laser treatment, photodynamic therapy, acne surgery, cryodestruction or chemodestruction, x-ray therapy, intralesional steroids, dermabrasion; 7. Phototherapy: Patients who are currently using, plan to use during the study, or discontinued less than 4 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. Systemic therapies: Patients who are currently using, plan to use during the study, or discontinued less than 12 weeks before study baseline the use of systemic therapies for the treatment of acne, including but not limited to: antibiotics, isotretinoin. Other systemic therapy that could affect the patient’s acne (i.e., anabolics, lithium, EGRF inhibitors, iodides, systemic corticosteroids - except inhaled corticosteroids or intrathecal corticosteroids - or other immunosuppressants), in the opinion of the investigator. 9. Known systemic diseases that can lead to acneiform eruptions: 9.1. Increased androgen production. 1) Adrenal origin: e.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety will be evaluated as the primary objective of the study up to 52 weeks: 1. Incidence of all Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAES), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) throughout the study; with special attention to local TEAEs concerning the treated facial area (local dermal safety), and systemic TEAEs 2. Frequency of discontinuation of treatment due to TEAEs 3. Changes from baseline of vital signs during the study 4. Physical examination during the study 5. Changes from baseline of laboratory test at V5/Wk12 and V8/Wk52 6. Change from baseline of local tolerability- Application site signs/symptoms during the study* 7. Assessment of overall application site irritation at V5/Wk12, V6/Wk26, V7/Wk38 and V8/Wk52. *Local tolerability will be evaluated based on the following signs and symptoms: application site non-lesional erythema, application site exfoliation, and application site dryness, stinging, burning, itching. For each sign/symptom, a severity score will be assigned using a 4-point scale from 0 = absent to 3 = severe. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy will be evaluated as a secondary objective. IGA and PGA and lesion count assessments are to be performed by a qualified investigator. Training is required for all evaluators who perform IGA/PGA/ lesion count. Efficacy will be assessed by the investigator using acne lesion count and IGA at V2/Day1 (Baseline), Wk4, Wk12, Wk26, Wk38, Wk52. Acne lesion count and IGA will also be performed for inclusion at V1 (screening) and in case of Early Termination Visit [ETV]). Acne lesion count: Inflammatory (papules, pustules and nodules) and non-inflammatory lesions (open [blackheads] and closed [whiteheads ] comedones) on the face (including the nose) and on the trunk will be accurately counted and recorded at each visit as detailed in the study schedule. Total lesions will be calculated as the sum of inflammatory plus non-inflammatory lesions. IGA (Face): Overall severity of acne will be assessed using a 5-point scale from 0 = clear to 4 = severe at each visit as detailed in the study schedule. PGA (Trunk): Overall severity will be assessed using a 5-point scale from 0 = clear to 4 = severe at each visit as detailed in the study schedule. Secondary Efficacy endpoints: To evaluate the efficacy of 5% N-Acetyl-GED-0507-34-Levo gel after a treatment period up to 52 Wks on the following parameters: FACE 1. Percentage of patients who have improvement of IGA score at each time point (Wk4, Wk8, Wk12, Wk26, Wk38, Wk52), vs baseline score 2. The percentage change from baseline in total lesion count (inflammatory plus non-inflammatory) at each time point (Wk4, Wk8, Wk12, Wk26, Wk38, Wk52) 3. Absolute change from baseline in total lesion count at each time point (Wk4, Wk8, Wk12, Wk26, Wk38, Wk52) 4. Change from baseline in inflammatory lesion count (percentage and absolute), at each time point (Wk4, Wk8, Wk12, Wk26, Wk38, Wk52) 5. Change from baseline in non-inflammatory lesion count (percentage and absolute), at each time point (Wk4, Wk8, Wk12, Wk26, Wk38, Wk52) TRUNK 1. Percen | — |
Countries
England, France, Italy, Poland, Scotland, Spain, United Kingdom, Wales
Outcome results
None listed