Evaluation of BTX 1503 in Patients With Moderate to Severe Acne Vulgaris

NCT03573518 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BTX.2018.001
• Study Type: interventional
• Target: 368
• Locations: 2 countries
• Sites: 36

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.

Conditions

Acne Vulgaris

Keywords

Synthetic CBD; Cannabidiol

Outcome Measures

Primary Outcomes (1)

• Safety as Measured by Reported Adverse Events

  Summary of Treatment-Emergent Adverse Events by MedDra Preferred Term that Occurred with a Frequency \> 2% in any Treatment Group (Safety Population)

  Day 84

Secondary Outcomes (1)

• Absolute Change From Baseline in Inflammatory Lesion Counts

  Day 84

Study Arms (5)

BTX 1503 5% BID

EXPERIMENTAL

BTX 1503 5% CBD (w/w) solution twice daily

Drug: BTX 1503

BTX 1503 5% QD

EXPERIMENTAL

BTX 1503 5% CBD (w/w) solution once daily

Drug: BTX 1503

BTX 1503 2.5% QD

EXPERIMENTAL

BTX 1503 2.5% CBD (w/w) solution once daily

Drug: BTX 1503

Vehicle BID

PLACEBO COMPARATOR

Vehicle twice daily

Drug: Vehicle

Vehicle QD

PLACEBO COMPARATOR

Vehicle once daily

Drug: Vehicle

Interventions

BTX 1503 DRUG

BTX 1503 Dose 1 liquid formulation, or BTX 1503 Dose 2 liquid formulation

Also known as: BTX1503

BTX 1503 2.5% QD; BTX 1503 5% BID; BTX 1503 5% QD

Vehicle DRUG

Placebo

Vehicle BID; Vehicle QD

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subject (or legal guardian) has the ability and willingness to sign a written informed consent/assent.
• Subject is of either gender and 12 to 40 years of age.
• 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.
• Subject has suitable venous access for blood sampling.
• Subject is able and willing to complete the study and to comply with all study instructions and attend the necessary visits.
• Subject has acne vulgaris of the face defined as:
• to 50 (inclusive) inflammatory lesions on the face
• to 100 (inclusive) non-inflammatory lesions on the face
• An Investigator's Global Assessment (IGA) score for acne severity of 3 or 4 (moderate or severe) assessed on the face.
• Subject has ≤ 2 nodular/cystic acne lesions (\>5 mm in diameter).
• Subject must refrain from the use of other treatments for acne during the study.
• 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.
• Subject must agree to maintain their regular use of sunscreens, moisturizers, shaving cream, and facial make up throughout the entire course of the study.
• 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.
• 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.

You may not qualify if:

• 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.
• Female subject who is breast feeding, pregnant, or planning to become pregnant any time during the course of the study.
• Subject with history of known or suspected intolerance to the drug product excipients.
• Subject has known HIV infection.
• 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.
• Subject has severe truncal acne.
• Subject has excessive facial hair that would interfere with the evaluation of safety or with the diagnosis or assessment of acne vulgaris.
• 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.
• Subject has any skin condition of the face other than acne vulgaris.
• Subject has used oral retinoid (e.g. isotretinoin) within 6 months (180 days) prior to the Baseline Visit.
• Subject has used Vitamin A supplements greater than 10,000 units/day within 6 months (180 days) prior to the Baseline Visit.
• Subject has used androgen receptor blockers (such as spironolactone or flutamide) within 3 months (90 days) prior to the Baseline Visit.
• Subject has initiated treatment with hormonal therapy or changed dosing with hormonal therapy within 3 months (90 days) prior to the Baseline Visit.
• Subject has had facial procedures (chemical or laser peel, microdermabrasion, etc.) within 8 weeks (56 days) prior to the Baseline Visit.
• Subject has had treatment with systemic antibiotics within 4 weeks (28 days) prior to the Baseline Visit.

Sponsors & Collaborators

• Botanix Pharmaceuticals: lead

Study Sites (36)

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212, United States

Location

Encino Research Center

Encino, California, 91436, United States

Location

Dermatology Specialist, Inc.

Murrieta, California, 92562, United States

Location

Quest Dermatology Research

Northridge, California, 91324, United States

Location

Clinical Science Insitute

Santa Monica, California, 90404, United States

Location

Well Phrama Medical Research

Miami, Florida, 33143, United States

Location

Tory Sullivan, M.D., PA

North Miami Beach, Florida, 33162, United States

Location

Precision Clinical Research

Sunrise, Florida, 33351, United States

Location

DS Research - Louisville

Louisville, Kentucky, 40241, United States

Location

Delricht Research

New Orleans, Louisiana, 70115, United States

Location

Metro Boston Clinical

Brighton, Maine, 02135, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Medisearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Washington University School of Medicine - Dermatology

St Louis, Missouri, 63141, United States

Location

JDR Dermatology Research

Las Vegas, Nevada, 89148, United States

Location

The Acne Treatment and Research Center

Morristown, New Jersey, 07960, United States

Location

Aventiv Research

Dublin, Ohio, 43016, United States

Location

Penn State Hershey Medical

Hershey, Pennsylvania, 17033, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

Greenville Dermatology, LLC

Greenville, South Carolina, 29607, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Avant Research Associates, LLC

Austin, Texas, 78704, United States

Location

DermReasearch

Austin, Texas, 78759, United States

Location

J&S Studies, Inc.

College Station, Texas, 77845, United States

Location

Suzanne Bruce and Associates, PA

Houston, Texas, 77056, United States

Location

Cmax Clinical Research

Adelaide, 5000, Australia

Location

The Skin Centre

Benowa, 4217, Australia

Location

Burswood Dermatology

Burwood, 6100, Australia

Location

Skin & Canver Foundation Inc.

Carlton, 053, Australia

Location

Sinclair Dermatology

East Melbourne, 3002, Australia

Location

Fremantle Dermatology

Fremantle, 6160, Australia

Location

North Eastern Health Specialist

Hectorville, 5073, Australia

Location

St George Dermatology & Skim Cancer Center

Kogarah, 2217, Australia

Location

Captain Sterline Medical Centre

Nedlands, 6009, Australia

Location

Woden Dermatology

Phillip, 2606, Australia

Location

Varacity Clinical Research

Woolloongabba, 4102, Australia

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Head of Development
• Organization: Botanix Pharmaceuticals

trials@botanixpharma.com

+1 445 300 3403

Study Officials

• Anthony Robinson, CRNP

  Head of Development, Botanix Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 29, 2018
• Study Start: June 26, 2018
• Primary Completion: August 16, 2019
• Study Completion: September 5, 2019
• Last Updated: April 18, 2022
• Results First Posted: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (25); AU (11)