A Study to Assess Efficacy and Safety of N-Acetyl-GED-0507-34-LEVO Gel 5% in Patients With Acne Vā¦ (NCT07384208) | Clinical Trial Compass
Active ā Not RecruitingPhase 3
A Study to Assess Efficacy and Safety of N-Acetyl-GED-0507-34-LEVO Gel 5% in Patients With Acne Vulgaris (GEDACNE 2)
Italy400 participantsStarted 2024-11-19
Plain-language summary
The clinical trial aims to test a new drug for acne vulgaris. The trial is performed to answer this question "Is it possible to reduce the number of skin lesions on your face/trunk, after daily applications for 12 consecutive weeks of a new drug?". The trial aims to accurately measure the effects of the new treatment (N-Acetyl-GED-0507-34-LEVO gel 5%) and to achieve this, patients will be randomly assigned to one of the following treatments:
* Study drug 1: test item, containing active ingredient
* Study drug 2: a preparation not containing any active ingredient (vehicle). Researchers will compare active to vehicle to see if there are differences in the efficacy.
Participants will:
* Apply drug or a placebo every day for 12 weeks
* Visit the site once every 4 weeks for checkups and tests (where applicable)
* Record on a diary the daily applications of the study drug at home, and record any adverse events
Who can participate
Age range9 Years ā 50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Informed consent obtained: Written informed consent, before any study-related procedure, personally signed and dated by the patient if the patient is ā„ 18 years old, or signed and dated by the parents or the legal guardian(s) if the patient is ā„ 9 to \< 18 years old. An additional informed assent form must be signed by patient if ā„ 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
ā. Sex and age: Male and female patients aged ā„ 9 and \<50 years
ā. Diagnosis at screening and baseline visits:
ā. 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
ā. 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:
ā. Hormonal oral, implantable, transdermal, or injectable contraceptives must be stable for at least 6 months before the baseline visit
What they're measuring
1
The relative change from baseline in total lesion count (inflammatory plus non-inflammatory) at V5/Wk12 on the face
Timeframe: From enrollment to the end of treatment at 12 weeks
2
Proportion of patients with an IGA success (face) at V5/Wk12.
Timeframe: From enrollment to the end of treatment at 12 weeks
ā. A non-hormonal intrauterine device (IUD) must be started at least 2 months before the baseline visit.
Exclusion criteria
ā. Acne:
ā. Beard and facial/body hair, tattoos:
ā. 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 the evaluation of acne or place the patient at unacceptable risk
ā. Allergy: Known or suspected hypersensitivity to any active or inactive ingredient in the study medications. Patients with a history of an allergic reaction or significant sensitivity to the formulations' ingredients
ā. Topical therapies: Patients who are currently using, will use during the study, or discontinued less than 4 weeks before study baseline the use of prescribed and/or over-the-counter topical therapies for the treatment of acne, including but not limited to: corticosteroids, antibiotics, azelaic acid, benzoyl peroxide, salicylates, Ī±-hydroxy/glycolic acid, any other topical cosmetic therapy for acne and retinoids on the face/trunk
ā. Topical skin care products and procedures: Patients who are currently using, will 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
ā. Phototherapy: Patients who are currently using, will 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
ā. Systemic therapies: Patients who are currently using, will 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