Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris

NCT06905210 | Not Yet Recruiting Phase 3

• 1 other identifier: EF190
• Study Type: interventional
• Target: 526
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase III randomized, double-blind, placebo-controlled, adaptive, multicenter study evaluates the efficacy and safety of a new concentration of the fixed-dose combination EF190 in women with moderate acne vulgaris over six 28-day treatment cycles. Eligible participants will be randomized (2:1) to receive either the experimental drug or placebo alongside standard skincare. The study includes five in-person visits (screening, randomization, and three follow-ups) and three phone contacts (cycles 2, 4, and 5) to monitor adherence, adverse events, and contraceptive use. A subgroup will undergo additional exploratory assessments, including acne questionnaires, ovarian activity tests, photographic documentation, and specialized lab/ultrasound exams.

Conditions

Acne Vulgaris; Acne Vulgaris on the Face

Keywords

Acne treatment; fixed-dose combination; moderate acne; randomized controlled trial; women's dermatology; adaptive clinical study; efficacy & safety evaluation; hormonal acne research; Moderate acne vulgaris; Phase III; Randomized; Double-blind; Placebo-controlled; Adaptive design; Multicenter; Superiority trial

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in the inflammatory lesion count at cycle 6.

  Inflammatory lesion refears to open and closed comedones, papules, pustules, and nodules

  28 weeks

• Change from Baseline in the percentage of participants with scores 0 or 1 in the Static Investigator Global Assessment (ISGA) at cycle 6.

  0 corresponds to "normal, clear skin with no evidence of acne vulgaris."; 1 corresponds to "skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red). No nodular lesions are present."; 5 indicates "numerous highly inflammatory lesions predominate, with a variable number of comedones, many papules and pustules, or nodular lesions."

  28 weeks

Secondary Outcomes (3)

• Change from Baseline in the inflammatory lesion count at cycle 3.

  14 weeks

• Change from Baseline in the percentage of participants with scores 0 or 1 in the Static Investigator Global Assessment (ISGA) at cycle 3.

  14 weeks

• Absolute change from Baseline in the Acne-Specific Quality of Life Questionnaire (Acne-QoL) at cycle 3 and cycle 6.

  14 and 28 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Drug: Experimental drug

Placebo Group

PLACEBO COMPARATOR

Drug: Placebo of the experimental drug

Interventions

Placebo of the experimental drug DRUG

Subjects randomized to this group will receive one (01) placebo of the experimental drug everyday for 28 weeks.

Placebo Group

Experimental drug DRUG

Subjects randomized to this group will receive one (01) experimental drug everyday for 28 weeks.

Experimental Group

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ability to confirm voluntary participation and agree to all trial procedures by signing the Informed Consent Form (ICF) and Informed Assent Form (ITA), if applicable, prior to any procedure provided for in the protocol. Note: The adult participant or the participant's guardian when the participant is a legal minor (adolescent) must sign the ICF after understanding and agreeing to all trial procedures. The adolescent participant must provide assent by signing the ITA based on local regulations and/or guidelines prior to the start of any study procedures.
• Female sex.
• Age between 14 and 45 years (inclusive).
• At least one year after menarche.
• At least one menstrual period during the last 03 months.
• Absence of known contraindications for the use of combined oral contraceptives. 7. Diagnosis of moderate acne vulgaris on the face for at least six months, characterized by the presence of:
• Note: Information regarding the duration of the disease can be obtained from the clinical history reported by the participant or from a brief medical report of the participant's history, if she is referred from another service.
• At least 15 inflammatory lesions (papules or pustules);
• At least 10 non-inflammatory lesions (comedones); and
• Up to 03 small inactive nodules. Note: Nodules are lesions between 10 and 30 mm, more palpable than visible.
• \. Classification ≥ 3 on the 6-point scale of the Investigator's Static Global Assessment (ISGA).
• \. When the participant did not obtain adequate results with topical treatment, failure or impossibility of systemic treatment with antibiotics (contraindications or intolerance) and the patient has an indication for the use of antiandrogens and/or isotretinoin.
• \. Agreement not to use other topical and/or systemic treatments for acne during the study.

You may not qualify if:

• \. Confirmed or suspected pregnancy. 2. History of childbirth, abortion or lactation in the last 3 months. 3. Participants who do not agree to use non-hormonal contraceptive methods permitted during the study, unless they are surgically sterile or who expressly declare themselves to be free from risk of pregnancy because they do not engage in sexual practices or engage in them in a non-reproductive manner.
• \. Current or previous treatment with agents described below with a washout period shorter than that provided for each:
• At least 6 months for systemic isotretinoin and/or injectable contraceptive (such as Depo Provera);
• At least 3 months for implantable contraceptives (such as Implanon) or Levonorgestrel-Releasing Intrauterine System (such as Mirena and Kyleena);
• At least 2 months for oral contraceptives or other systemic anti-acne agents not mentioned (such as systemic antibiotics);
• At least 4 weeks for topical retinoids;
• At least 2 weeks for other topical anti-acne agents (such as topical antibiotics or benzoyl peroxide); 5. Personal history or first-degree family history of vascular disease including previous arterial thromboembolic disease (myocardial infarction or stroke), venous thromboembolic disease (peripheral venous thrombosis or pulmonary embolism) or any condition that increases the risk for any of the previous conditions.
• \. Known personal history of thrombophilia. 7. Current smoking. 8. Any disease or condition that compromises the function of body systems that would result in altered absorption, excessive accumulation, impaired metabolism or altered excretion of the study medication, including malabsorptive conditions (such as previous bariatric surgery).
• \. Any condition that worsens under hormonal treatment or that interferes with the conduct of the study or interpretation of the results, such as gestational herpes or idiopathic jaundice during previous pregnancy, otosclerosis, Sydeham's chorea, porphyria, bile flow disorders (presence or history of cholestasis, gallstones, systemic lupus erythematosus).
• \. Other comorbidities (history or current diagnosis) such as chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), hemolytic uremic syndrome, headache with focal neurological symptoms, epilepsy, asthma with chronic use of oral corticosteroids, multiple sclerosis, Chorea minor, tetany, endometriosis, mastopathy, current premenstrual dysphoric disorder, sickle cell anemia, pancreatitis, vascular complications of diabetes, major depressive disorder or other conditions that, in the investigator's assessment, may compromise the participant's safety.
• \. Hypersensitivity to any of the components of the experimental drug or placebo.
• \. Presence of moderate to severe atopy, acne comedonica or acne conglobata, induced acne or acne with multiple large nodules, cysts, fistular comedones or fistular duct abscess or other dermatological conditions that, in the investigator's assessment, may compromise the evaluation of efficacy.
• \. Use of comedogenic creams or sunscreens, other preparations with sex hormones or any other anti-acne therapy (such as phototherapy, oleic acids, chemical peeling, mechanical extraction of comedones).
• \. Preparations with acnegenic effects, such as iodinated or brominated drugs, tuberculostatics, lithium, vitamins B1 (\> 1.5 mg/day), B6 (\> 2 mg/day) or B12 (\> 6 g/day), corticosteroids, adrenocorticotropic hormone (ACHT), anabolic steroids, quinine, disulfiram, methoxypsoralen, phenobarbital, phenytoin, trimethadione, thyroid depressants, certain oily cosmetics.
• \. History of drug abuse. 16. History of neoplasia in the last 5 years, except non-melanoma skin cancer, or any history of sex hormone-dependent neoplasia or current suspicion of neoplasia, including meningioma.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (1)

Eurofarma Laboratórios S.A

Itapevi, São Paulo, 06696-000, Brazil

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Drugs, Investigational

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Central Study Contacts

Gleyce Lima

CONTACT

+55 11 5090 8411; gleyce.lima@eurofarma.com

Luiza Terranova

CONTACT

+55 11 4144-9500; luiza.terranova@eurofarma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-03

Locations

BR (1)