A Phase III study to assess efficacy and safety of N-acetyl-GED-0507-34-LEVO gel 5%, applied once daily for 12 weeks in patients with acne vulgaris (GEDACNE-1)

PPM Services S.A0 sites400 target enrollmentSeptember 16, 2024

ConditionsAcne vulgaris Skin and Connective Tissue Diseases

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Acne vulgaris
Sponsor: PPM Services S.A
Enrollment: 400
Primary Endpoint: Efficacy is measured via analysis of the relative change in total lesion count (inflammatory plus noninflammatory) at baseline and Visit 5/Week12 on the face AND via the proportion of patients with a change in acne severity measured using the Investigators Global Assessment (IGA) at baseline and Visit 5/Week 12.
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 16, 2024

End Date

May 31, 2026

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

PPM Services S.A

Eligibility Criteria

Inclusion Criteria

•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 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.
•Sex and age: male and female patients aged =9 and <50 years.
•Diagnosis at screening and baseline visits: 3.
•Patients affected by facial acne vulgaris with: Investigator’s Global Assessment (IGA) score: 3.1.
•Equal to 3–4 if patient is >14 and <50 years old 3.1.
•=2 if the patient is =9 and =14 years old. 3.1.
•Face Inflammatory lesions: =20 and =100 inflammatory lesions (papules and pustules) and =1 nodules on the face 3.1.
•Face Non-inflammatory lesions: =20 and =100 non-inflammatory lesions (open and closed comedones) on the face 3.
•Patients affected also by truncal acne (optional criteria): 3.2.
•The patient has a truncal acne on areas of the trunk (shoulders, upper back and upper anterior chest) accessible for patient’s self-application of study medication with a severity grade equal to 2 or 3 on the Physician Global Assessment (PGA) scale. 3.2.

Exclusion Criteria

•Acne: Patients with a known history of acne persistent and unresponsive to topical and/or oral treatments within 6 months before randomisation, patients with generalised or localised acne forms other than acne vulgaris, or patients with acne requiring systemic treatment.
•Beard and facial/body hair, tattoos: Patients with a beard or who intend to grow a beard and/or to perform a facial tattoo during the study or patients with facial hair or facial tattoos that could interfere with study assessments in the investigator’s opinion. For patients with truncal acne: body hair, tattoos (or who intend to perform them) on the shoulders, upper back or upper anterior chest accessible to self-application of study medication by the patient that may interfere with the study assessments in the investigator’s opinion
•Skin diseases: Patients with other active skin diseases or active skin infections in the facial or truncal region or any other facial or truncal disease or condition that might interfere with the evaluation of acne or place the patient at unacceptable risk
•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
•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, a-hydroxy/glycolic acid, any other topical cosmetic therapy for acne and retinoids on the face/trunk
•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 moisturisers 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
•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
•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
•Known systemic diseases that can lead to acneiform eruptions:9.
•Increased androgen production:9.1.

Outcomes

Primary Outcomes

Efficacy is measured via analysis of the relative change in total lesion count (inflammatory plus noninflammatory) at baseline and Visit 5/Week12 on the face AND via the proportion of patients with a change in acne severity measured using the Investigators Global Assessment (IGA) at baseline and Visit 5/Week 12.

Secondary Outcomes

1. Efficacy is measured via analysis of the absolute change in total lesion count at baseline and Visit 5/Week 12 AND via the percentage of patients who achieve an IGA success over the study duration measured using the Investigators Global Assessment (IGA) at baseline and Visit 5/Week 122. Efficacy will also be measured via patient-reported outcomes using the Dermatology Life Quality Index (DLQI) or the Children’s Dermatology Life Quality Index (C-DLQI), scar assessments and photographic scar monitoring (at selected sites only) at baseline and Visit 5/Week 12