A Phase 2, Proof-of-concept, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AT-5214 in Subjects with Moderate to Severe Facial Acne Vulgaris
- Conditions
- Acne vulgarisSkin - Dermatological conditions
- Registration Number
- ACTRN12624000746538
- Lead Sponsor
- Atacama Therapeutics Australia, Pty Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 100
Males and females aged >/= 16years at time of signing informed consent.
- Subject has oily skin as measured on three locations on the face using Sebometer, oily skin being defined as sebum level >100mcg/cm2.
- Subject has moderate to severe (3 or 4 on IGA scale) facial acne vulgaris (including the nose).
- Nonsmoker and/or ex-smoker who has discontinued smoking and/or use of nicotine-containing products, including vaping, for at least 6 months prior to Screening.
- Subject has used the same type and brand of make-up, other facial products (including cleanser) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the study start and agrees to continue his/her other general skin and hair care products and regimen for the entire study.
- Body mass index (BMI) within the range 18 to 30 kg/m2 (inclusive).
- Females of childbearing potential and not abstinent, must be willing to use at least 2 highly effective methods of contraception (hormonal contraception [stable dose for 3 months], intrauterine device/intrauterine hormone-releasing system, and barrier contraceptive method [diaphragm, cervical cap, contraceptive sponge, condom) from screening to 30 days after the last dose of study intervention. Females who are abstinent are not required to use a contraceptive method unless they become sexually active. Alternatively, females must be postmenopausal for >/=1 year or surgically sterile (with tubal ligation, hysterectomy, or bilateral oophorectomy) for >/=6 months.
- Males with female partners of childbearing potential will agree to use barrier contraceptive (i.e., condom) and their female partners must use a highly effective method of contraception from screening to 90 days after the last dose of study intervention. Males also must refrain from sperm donations during this time period. Males who are abstinent are not required to use a contraceptive method unless they become sexually active.
- Subject has rosacea.
- Presence of a significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- Abnormal blood pressure (resting heart rate < /=40 or >/=100 bpm or resting blood pressure <90/40 mmHg or >150/90 mmHg) at screening or before the first administration of study intervention.
- Any other abnormal vital signs that are considered to be clinically significant by the investigator.
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Breast cancer within the past 10 years.
- Any clinically significant laboratory abnormality at the screening visit or before the administration of the first dose of study intervention.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- QTcF (QT with Fredericia’s correction) >/=450 msec.
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Inability to tolerate oral medication.
- Subject has used any of the following topical preparations on the face:
- Topical anti-acne treatments including but not limited to over-the-counter acne cleaners or treatments, benzoyl peroxide, azelaic acid, sulfa-based products, corticosteroids and salicylic acid within 2 weeks of the initiation of treatment.
- Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks of the initiation of treatment.
- Topical anti-acne treatments containing antibiotics within 4 weeks of the initiation of treatment.
Subject has used any of the following systemic medications:
- Corticosteroids (including intramuscular and intralesional injections) within four weeks of the initiation of treatment. Inhaled, intranasal or ocular corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least four [4] weeks prior to the initiation of treatment).
- Antibiotics within 4 weeks of the initiation of treatment with the exception of 5 days or less of antibiotic therapy during this period, but with no antibiotics use permitted within 1 week prior to the initiation of treatment.
- Spironolactone within 4 weeks of the initiation of treatment with the exception of 5 days or less of spironolactone therapy during this period, but with no spironolactone use permitted within 1 week prior to the initiation of treatment.
- Retinoid therapy within 6 months of the initiation of treatment.
- Live vaccine(s) within 1 month before Screening or plans to receive such vaccines during the study.
- Currently enrolled in an investigational drug or device study. Received an investigational drug or treated with an investigational device within 60 days or a minimum of 5 half-lives of the active investigational product prior to screening.
- Positive prestudy drug screen.
- Positive human immunodeficiency virus (HIV) or hepatitis C antibody test (HCV), or hepatitis B surface antigen (HBsAg) at screening or 3 months before enrollment.
- Subject is a smoker or user of nicotine products. Ex-smokers are eligible as long as they stopped s
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of oral AT-5214 or placebo 4 mg BID for 12 weeks on the investigator global assessment scale (IGA) in participants with moderate to severe facial acne vulgaris.<br><br>Investigator global assessment of acne severity will be conducted at Screening (required for entry into the study), Day 1, Week 4, Week 8, and Week 12 post-baseline. An IGA score will be established for each participant.[ Absolute change from baseline in mean IGA score in each treatment group at Week 12 post-baseline (end of treatment).<br>The IGA score will be assessed at day 1, week 4, week 8 and week 12 post-baseline. ]
- Secondary Outcome Measures
Name Time Method