Clinical trial for Acne Vulgaris
Official title Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris
ClinicalTrials.gov ID: NCT06905210
What this study is testing
What is Experimental drug?
Experimental drug is an investigational medicine, being studied as a potential treatment for acne vulgaris.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 45, women only
You may be able to join if
- Ability to confirm voluntary participation and agree to all trial procedures by signing the Informed Consent Form (ICF) and Informed Assent Form...
- 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.
You likely can't join if
- 1\. Confirmed or suspected pregnancy. 2. History of childbirth, abortion or lactation in the last 3 months. 3. Participants who do not agree to use...
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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. 8\. Classification ≥ 3 on the 6-point scale of the Investigator's Static Global Assessment (ISGA). 9\. When...
- 1\. 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Itapevi, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 14 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Itapevi, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.