Clinical trial NCT03573518: Evaluation of BTX 1503 in Patients With Moderate to Severe Acne Vulgaris
Official title: A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of BTX 1503 in Patients With Moderate to Severe Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: Synthetic CBD
Cannabidiol
Lead sponsor: Botanix Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-06-29
Enrollment: 368
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess safety and efficacy of various doses of BTX 1503 liquid formulation in subjects with moderate to severe acne vulgaris of the face.

Detailed description: This will be a multi-center, randomized, double-blinded, vehicle-controlled, parallel group, dose-finding study in pediatrics, adolescents and adults (aged 12 to 40 years). The objective of this study is to assess the safety and efficacy of various doses of BTX 1503 in subjects with moderate to severe acne vulgaris of the face.

Eligibility criteria: Inclusion Criteria:

1. Subject (or legal guardian) has the ability and willingness to sign a written informed consent/assent.
2. Subject is of either gender and 12 to 40 years of age.
3. Subject is in good general health without clinically significant haematological, cardiac, respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or malignant disease, as determined by the investigator.
4. Subject has suitable venous access for blood sampling.
5. Subject is able and willing to complete the study and to comply with all study instructions and attend the necessary visits.
6. Subject has acne vulgaris of the face defined as:

   1. 20 to 50 (inclusive) inflammatory lesions on the face
   2. 20 to 100 (inclusive) non-inflammatory lesions on the face
   3. An Investigator's Global Assessment (IGA) score for acne severity of 3 or 4 (moderate or severe) assessed on the face.
7. Subject has ≤ 2 nodular/cystic acne lesions (\>5 mm in diameter).
8. Subject must refrain from the use of other treatments for acne during the study.
9. Subject must agree to not wash or shave their face, swim or otherwise get their face wet for at least 1 hour after application of study medication.
10. Subject must agree to maintain their regular use of sunscreens, moisturizers, shaving cream, and facial make up throughout the entire course of the study.
11. Male subjects and their partners must agree and commit to use a barrier method of contraception during the study and for 90 days after last study drug application.
12. A negative UPT result for all WOCBP at the Screening Visit and Baseline Visit, if applicable. A WOCBP is one who is not permanently sterilized or is not postmenopausal. Postmenopausal is defined as 24 months with no menses without an alternative medical cause.
13. Sexually active women must agree to use the following throughout the study and for 30 days after last study drug application:

    a. One of these highly effective contraception methods i. 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) i. Male or female condom; diaphragm; cervical cap.
14. Male subjects must refrain from sperm donation during the study treatment period until 90 days after final study drug administration.
15. Male subjects 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 Criteria:

1. People who would otherwise qualify for the study but are living in the same household as a study subject, are not allowed to participate in the study.
2. Female subject who is breast feeding, pregnant, or planning to become pregnant any time during the course of the study.
3. Subject with history of known or suspected intolerance to the drug product excipients.
4. Subject has known HIV infection.
5. Subject has acne conglobata, acne fulminans, secondary acne (chloracne), pseudo-folliculitis, severe acne requiring systemic treatment, or is taking a medication known to induce or exacerbate acne.
6. Subject has severe truncal acne.
7. Subject has excessive facial hair that would interfere with the evaluation of safety or with the diagnosis or assessment of acne vulgaris.
8. Subject 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.
9. Subject has any skin condition of the face other than acne vulgaris.
10. Subject has used oral retinoid (e.g. isotretinoin) within 6 months (180 days) prior to the Baseline Visit.
11. Subject has used Vitamin A supplements greater than 10,000 units/day within 6 months (180 days) prior to the Baseline Visit.
12. Subject has used androgen receptor blockers (such as spironolactone or flutamide) within 3 months (90 days) prior to the Baseline Visit.
13. Subject has initiated treatment with hormonal therapy or changed dosing with hormonal therapy within 3 months (90 days) prior to the Baseline Visit.
14. Subject has had facial procedures (chemical or laser peel, microdermabrasion, etc.) within 8 weeks (56 days) prior to the Baseline Visit.
15. Subject has had treatment with systemic antibiotics within 4 weeks (28 days) prior to the Baseline Visit.
16. Subject has had treatment with systemic anti-acne drugs within 4 weeks (28 days) prior to the Baseline Visit.
17. Subject has had treatment with systemic anti-inflammatory drugs within 4 weeks (28 days) prior to the Baseline Visit.
18. Subject has had treatment with systemic (oral) corticosteroids other immunosuppressive medications within 4 weeks (28 days) prior to the Baseline Visit.
19. Subject has had treatment with prescription topical retinoid use on the face (e.g. tretinoin, tazarotene) within 4 weeks (28 days) prior to the Baseline Visit.
20. Subject has had treatment with topical prescription antibiotics (e.g. dapsone, clindamycin, erythromycin, or sulfacetamide) or combination products that include a topical antibiotic within 2 weeks (14 days) prior to the Baseline Visit.
21. Subject has had treatment with over-the-counter (OTC) topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti- inflammatory medications, corticosteroids, adapalene, α-hydroxy/glycolic acid on the face within 2 weeks (14 days) prior to the Baseline Visit.
22. Subject is currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
23. Subject has had photodynamic therapy within 8 weeks (56 days) prior to the Baseline Visit.
24. Subject has used a tanning bed within 2 weeks (14 days) prior to the Baseline Visit.
25. Subject has used home-based light treatment within 2 weeks (14 days) prior to the Baseline Visit.
26. Subject has an underlying disease that requires the use of interfering topical or systemic therapy.
27. Subject 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.
28. Subject has had excessive sun exposure (in the opinion of the investigator) within one week prior to the Baseline Visit and an unwillingness to refrain from excessive sun exposure during the study.
29. Subject 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 subject at undue risk. This may include respiratory (including chronic asthma requiring repetitive drug interventions), gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders.
30. Subject has a clinically relevant history of, or current evidence of, abuse of alcohol or other drugs. Subjects may be deemed eligible if the UDS identifies subject-reported, prescribed drugs or appropriate levels of alcohol, as determined by the investigator.
31. Subject has participated in another investigational drug or device research study within 4 weeks (28 days) of the Baseline Visit or five half-lives of the drug, whichever is longer.
32. Any other reason that would make the subject, in the opinion of the investigator or sponsor, unsuitable for the study.

Primary outcomes:
measure: Safety as Measured by Reported Adverse Events
timeFrame: Day 84
Secondary outcomes:
measure: Absolute Change From Baseline in Inflammatory Lesion Counts
timeFrame: Day 84
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Encino
country: United States
facility: Encino Research Center
state: California
city: Murrieta
country: United States
facility: Dermatology Specialist, Inc.
state: California
city: Northridge
country: United States
facility: Quest Dermatology Research
state: California
city: Santa Monica
country: United States
facility: Clinical Science Insitute
state: California
city: Miami
country: United States
facility: Well Phrama Medical Research
state: Florida
city: North Miami Beach
country: United States
facility: Tory Sullivan, M.D., PA
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: Louisville
country: United States
facility: DS Research - Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Delricht Research
state: Louisiana
city: Brighton
country: United States
facility: Metro Boston Clinical
state: Maine
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Saint Joseph
country: United States
facility: Medisearch Clinical Trials
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine - Dermatology
state: Missouri
city: Las Vegas
country: United States
facility: JDR Dermatology Research
state: Nevada
city: Morristown
country: United States
facility: The Acne Treatment and Research Center
state: New Jersey
city: Dublin
country: United States
facility: Aventiv Research
state: Ohio
city: Hershey
country: United States
facility: Penn State Hershey Medical
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Greenville
country: United States
facility: Greenville Dermatology, LLC
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Austin
country: United States
facility: Avant Research Associates, LLC
state: Texas
city: Austin
country: United States
facility: DermReasearch
state: Texas
city: College Station
country: United States
facility: J&S Studies, Inc.
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, PA
state: Texas
city: Adelaide
country: Australia
facility: Cmax Clinical Research
city: Benowa
country: Australia
facility: The Skin Centre
city: Burwood
country: Australia
facility: Burswood Dermatology
city: Carlton
country: Australia
facility: Skin & Canver Foundation Inc.
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
city: Fremantle
country: Australia
facility: Fremantle Dermatology
city: Hectorville
country: Australia
facility: North Eastern Health Specialist
city: Kogarah
country: Australia
facility: St George Dermatology & Skim Cancer Center
city: Nedlands
country: Australia
facility: Captain Sterline Medical Centre
city: Phillip
country: Australia
facility: Woden Dermatology
city: Woolloongabba
country: Australia
facility: Varacity Clinical Research
Study officials:
affiliation: Head of Development, Botanix Pharmaceuticals
name: Anthony Robinson, CRNP
role: STUDY_DIRECTOR
References: