A double-blind, randomized, vehicle-controlled clinical multi-center study to evaluate the efficacy and safety of N-Acetyl-GED-0507-34-LEVO gel, 2 and 5%, applied once daily for 12 weeks in patients with facial acne vulgaris
- Conditions
- facial acne vulgarisMedDRA version: 20.0Level: PTClassification code 10000496Term: AcneSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-003307-19-DE
- Lead Sponsor
- PPM SERVICES S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
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 < 18 years old. An additional informed assent form must be signed by patient if = 14 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. Male and female patients aged = 14 to = 30 years old inclusive;
3. Diagnosis: Patients with facial acne vulgaris with an investigator’s global assessment (IGA) score of 3–4 at screening and baseline visits; 4. Inflammatory lesions: Patients with = 20 and = 100 inflammatory lesions (papules and pustules) on the face (excluding the nose) and = 1 nodules;
5. Non-inflammatory lesions: Patients with = 20 and = 100 non-inflammatory lesions (open and closed comedones) on the face (excluding the nose);
6. Full comprehension: Patient’s and parent(s)/legal guardian for <18 years old patient’s ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study;
7. Women of childbearing potential* who are sexually active with a male partner must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as:
•Hormonal oral, implantable, transdermal, or injectable contraceptives must be stable for at least 6 months before the screening visit
•A non-hormonal intrauterine device (IUD) must be started at least 2 months before the screening visit
•Sexual abstinence in accordance to the preferred life style or vasectomized partner** during the 12-week treatment period
*Note: According to Reccomendations related to contraception and pregnancy testing in clinical trials (CTFG, September 2014), a woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
**Note: Provided that partner is the sole sexual partner of the female trial participant and has received medical assessment of the surgical success.
Are the trial subjects under 18? yes
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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method