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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID: NCT03573518
Run by: Botanix Pharmaceuticals
People needed: 368
Starts: 2018-06-26
Expected to finish: 2019-09-05
Last updated by the study team: 2022-04-18

Who can join

Age: 12 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

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:
20 to 50 (inclusive) inflammatory lesions on the face
20 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.
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.
Male subjects must refrain from sperm donation during the study treatment period until 90 days after final study drug administration.
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.

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.
Subject has had treatment with systemic anti-acne drugs within 4 weeks (28 days) prior to the Baseline Visit.
Subject has had treatment with systemic anti-inflammatory drugs within 4 weeks (28 days) prior to the Baseline Visit.
Subject has had treatment with systemic (oral) corticosteroids other immunosuppressive medications within 4 weeks (28 days) prior to the Baseline Visit.
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.
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.
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.
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.
Subject has had photodynamic therapy within 8 weeks (56 days) prior to the Baseline Visit.
Subject has used a tanning bed within 2 weeks (14 days) prior to the Baseline Visit.
Subject has used home-based light treatment within 2 weeks (14 days) prior to the Baseline Visit.

Where it is running

Applied Research Center of Arkansas — Little Rock, Arkansas, United States
Encino Research Center — Encino, California, United States
Dermatology Specialist, Inc. — Murrieta, California, United States
Quest Dermatology Research — Northridge, California, United States
Clinical Science Insitute — Santa Monica, California, United States
Well Phrama Medical Research — Miami, Florida, United States
Tory Sullivan, M.D., PA — North Miami Beach, Florida, United States
Precision Clinical Research — Sunrise, Florida, United States
DS Research - Louisville — Louisville, Kentucky, United States
Delricht Research — New Orleans, Louisiana, United States
Metro Boston Clinical — Brighton, Maine, United States
Minnesota Clinical Study Center — Fridley, Minnesota, United States
Medisearch Clinical Trials — Saint Joseph, Missouri, United States
Washington University School of Medicine - Dermatology — St Louis, Missouri, United States
JDR Dermatology Research — Las Vegas, Nevada, United States
The Acne Treatment and Research Center — Morristown, New Jersey, United States
Aventiv Research — Dublin, Ohio, United States
Penn State Hershey Medical — Hershey, Pennsylvania, United States
Clinical Partners, LLC — Johnston, Rhode Island, United States
Greenville Dermatology, LLC — Greenville, South Carolina, United States
Coastal Carolina Research Center — Mt. Pleasant, South Carolina, United States
Avant Research Associates, LLC — Austin, Texas, United States
DermReasearch — Austin, Texas, United States
J&S Studies, Inc. — College Station, Texas, United States
Suzanne Bruce and Associates, PA — Houston, Texas, United States

Full record on ClinicalTrials.gov

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