Study of BTX 1503 Solution in Patients with Acne Vulgaris
An Open-Label Study to Evaluate the Safety and Tolerability of BTX 1503 Solution in Patients with Acne Vulgaris
Botanix Pharmaceuticals Ltd
16 participants
Oct 24, 2017
Interventional
Conditions
Summary
Purpose The purpose of this study is to describe the safety of treatment with the study drug (BTX 1503 5% Solution) with twice daily dosing in subjects with acne vulgaris. The study drug’s effect on acne vulgaris will be evaluated. Study participants Patients with acne vulgaris aged between 18 and 65 years, inclusive, will participate. Experimental Treatment The study will investigate 3mL of BTX 1503 5% Solution applied twice daily to the face for 28 days. The study consists of a screening visit (up to 14 days before receiving study treatment) and an enrolment visit initially. On Day 7, a call will be made to each participant to ensure that they continue with dosing per instructions. There is a visit on Day 14 during the 28 day dosing period. Participants will return to the clinic on Day 28 for safety assessments. There is a follow up visit on Day 35. The maximum study duration for any participant will be a total of up to 49 days; screening period (up to 14 days), 28 days of treatment, and 1 week of follow-up.
Eligibility
Inclusion Criteria25
- Participant (or legal guardian) has the ability and willingness to sign a written informed consent.
- Participant is of either gender between 18 and 65 years of age, inclusive.
- Participant is in good general health without clinically significant haematological, cardiac, respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or malignant disease, as determined by the investigator.
- Participant has suitable venous access for blood sampling.
- Participant is able and willing to complete the study and to comply with all study instructions and attend the necessary visits.
- Participant has acne vulgaris of the face defined as:
- a. 20 to 50 (inclusive) inflammatory lesions on the face
- b. 20 to 100 (inclusive) non-inflammatory lesions on the face
- c. An Investigator Global Assessment (IGA) score for acne severity of 3 or 4 (moderate or severe) assessed on the face.
- Participant has <= 3 nodular/cystic acne lesions (>5 mm in diameter)
- Participant must be willing to use the facial cleanser provided (Neutrogena) throughout the study.
- Participant must refrain from the use of other treatments for acne during the study.
- Participant must agree to not wash their face for 4 hours after application of study medication.
- Participant must agree that shaving cream and provided facial cleansers will not be used within 5 minutes prior to, or for 4 hours after, application of study medication.
- Participant must agree to maintain their regular use of sunscreens, moisturisers, and facial makeup throughout the entire course of the study and not apply sunscreens, moisturisers, or facial makeup within 4 hours prior to, or 1 hour after, study drug application.
- Participant agrees to not use marijuana products throughout the study.
- Male participants and their partners must agree and commit to use a barrier method of contraception during the study.
- A negative urine pregnancy test (UPT) result for all WOCBP at the Screening Visit and Baseline visit, if applicable. A WOCBP is one who is permanently sterilised or is postmenopausal. Postmenopausal is defined as 12 months with no menses without an alternative medical cause.
- Sexually active women must agree to use:
- a. One of these highly effective contraception methods - Intrauterine device (IUD); hormonal (injections, implants, transdermal patch, vaginal ring; tubal ligation; partner vasectomy, OR
- b. Oral contraceptives WITH a barrier method (listed below), OR
- c. Two barrier forms of contraception (listed below)
- Male or female condom; diaphragm; cervical cap.
- Male participants must refrain from sperm donation during the study treatment period until 90 days after final study drug administration.
- Male participants must agree to keep their face clean shaven (no moustache or goatee; short sideburns acceptable) throughout the study and use the same method for shaving as was used for the 4 weeks prior to the Screening Visit.
Exclusion Criteria26
- Female participant who is breast feeding, pregnant, or planning to become pregnant any time during the course of the study.
- Participant with history of known or suspected intolerance to dimethicone containing products, or drug product excipients (hexamethyldisiloxane, polymethylsiloxane, and polypropylene glycol (PPG) 15 stearyl ether).
- Participant has used any marijuana products, via any route, within 4 weeks prior to the Screening Visit. A urine drug test positive for THC will exclude the participant.
- Participant has known HIV infection.
- Participant has acne conglobata, acne fulminans, secondary acne (chloracne), drug-induced acne, pseudo-folliculitis, or severe acne requiring systemic treatment.
- Participant has severe truncal acne.
- Participant has excessive facial hair that would interfere with the evaluation of safety or with the diagnosis or assessment of acne vulgaris.
- Participant has sunburns, unevenness in skin tones, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality that would result in the inability to evaluate the skin of the face.
- Participant has any skin condition of the face other than acne vulgaris.
- Participant started a topical medication regimen for treatment of acne vulgaris on the face within 14 days of the Screening Visit.
- Participant has used systemic corticosteroids, oral antibiotics, anti-inflammatory drugs (NSAIDs are permitted) or a prescription topical retinoid on the face within 4 weeks prior to the Screening Visit.
- Participant has initiated hormonal therapy or had a dose change to hormonal therapy within 12 weeks prior to the Screening Visit.
- Participant uses hormonal therapy solely for the control of acne.
- Participant has used androgen receptor blockers (eg, spironolactone) within 12 weeks prior to the Screening Visit.
- Participant has used oral retinoids (eg, isotretinoin) within 24 months prior to the Screening Visit.
- Participant has had facial procedures (eg, microdermabrasion, chemical or laser peel) within 8 weeks prior to the Screening Visit.
- Participant has had photodynamic therapy within 8 weeks prior to the Screening Visit.
- Participant has an underlying disease that requires the use of interfering topical or systemic therapy.
- Participant has other dermatological conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, psoriasis, perioral dermatitis, or rosacea.
- Participant has had excessive sun exposure (in the opinion of the investigator) within one week prior to the Screening Visit and an unwillingness to refrain from excessive sun exposure during the study.
- Participant has a clinically relevant history or currently suffering from any disease or condition that, in the opinion of the investigator, may affect the evaluation of the study product or place the participant at undue risk. This may include respiratory (including chronic asthma requiring repetitive drug interventions), gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders.
- Participant has a clinically relevant history of, or current evidence of, abuse of alcohol or other drugs. If the urine drug screen (UDS) at the Screening Visit is positive for any drugs of abuse, the participant is not eligible to participate. Participants may be deemed eligible if the UDS identifies participant-reported, prescribed drugs or appropriate levels of alcohol, as determined by the investigator.
- Participant has used systemic or other immunosuppressive medications within 4 weeks of the Screening Visit (inhaled corticosteroid <= 1000 µg daily dose is acceptable).
- Participant is currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the participant at undue risk.
- Participant has participated in another investigational drug or device research study within 30 days of the Screening Visit or five half-lives of the drug, whichever is longer.
- Any other reason that would make the participant, in the opinion of the investigator or sponsor, unsuitable for the study
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Approximately 16 participants with acne vulgaris will be enrolled and receive 3ml dose of BTX 1503 5% Solution twice daily. Participants will receive their initial application of study drug on Day 1 at the clinical sites administered by the clinical site staff. Participants will be instructed in how to apply study drug when not at the clinical site. Starting on the evening of Day 1, participants will apply their study drug at home. Each application of study drug will occur at approximately the same time in the morning with the second application 12 hours later. Participants will apply study drug twice daily through Day 27. Participants will apply study drug at the clinical site on the morning of Day 14 and on the morning of Day 28 (final dose). A diary will be maintained documenting compliance with application of the self-administered applications. Each dose of study drug will be applied to the entire face. Participants will be asked to apply the total amount of study drug per application evenly, as best as possible, to cover all the face.
Locations(4)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12617001127392