Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age14-45
SponsorEurofarma Laboratorios S.A.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo of the experimental drug
DrugSubjects randomized to this group will receive one (01) placebo of the experimental drug everyday for 24 weeks.
Experimental drug
DrugSubjects randomized to this group will receive one (01) experimental drug everyday for 24 weeks.
Treatment groups
531 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Absolute reduction from baseline in the number of inflammatory acne lesions assessed at Cycle 6.
Inflammatory lesion refears to open and closed comedones, papules, pustules, and nodules
Time frame
24 weeks2
Absolute reduction from baseline in the total number of acne lesions assessed at Cycle 6.
Acne lesions refears to open comedones, closed comedones, papules, pustules, and nodules.
Time frame
24 weeks3
Change from Baseline 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."
Time frame
24 weeksSecondary outcomes
1
Change from Baseline in the inflammatory lesion count at cycle 3.
Inflammatory lesion refears to open and closed comedones, papules, pustules, and nodules
Time frame
14 weeks2
Change from Baseline in the percentage of participants with scores 0 or 1 in the Static Investigator Global Assessment (ISGA) at cycle 3.
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."
Time frame
14 weeks3
Absolute change from Baseline in the Acne-Specific Quality of Life Questionnaire (Acne-QoL) at cycle 3 and cycle 6.
The questionnaire has four (4) domains: Self perception (score range, 0 - 30), Role-Social (0 - 24), Role-emotional (0 - 30), and Acne Symptons (0 - 30). Overall, tem sum for all domains scores range from 0 to 114. Each domain scores responses are numbered starting with '0' in ascending order (ie. extremely=0, very much=1, quite a bit=2, a good bit=3, somewhat=4, a little bit=5, not at all=6). Higher scores for each domain in Acne-Specific Quality of Life Questionnaire (Acne-QoL) reflect increased health related quality of life, ie. less negative self perception, social, emotional and symptomatic effects associated with acne.
Time frame
14 and 28 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov