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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03573518




Registration number
NCT03573518
Ethics application status
Date submitted
19/06/2018
Date registered
29/06/2018
Date last updated
18/04/2022

Titles & IDs
Public title
Evaluation of BTX 1503 in Patients With Moderate to Severe Acne Vulgaris
Scientific 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
Secondary ID [1] 0 0
BTX.2018.001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acne Vulgaris 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BTX 1503
Treatment: Drugs - Vehicle

Experimental: BTX 1503 5% BID - BTX 1503 5% CBD (w/w) solution twice daily

Experimental: BTX 1503 5% QD - BTX 1503 5% CBD (w/w) solution once daily

Experimental: BTX 1503 2.5% QD - BTX 1503 2.5% CBD (w/w) solution once daily

Placebo Comparator: Vehicle BID - Vehicle twice daily

Placebo Comparator: Vehicle QD - Vehicle once daily


Treatment: Drugs: BTX 1503
BTX 1503 Dose 1 liquid formulation, or BTX 1503 Dose 2 liquid formulation

Treatment: Drugs: Vehicle
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety as Measured by Reported Adverse Events
Timepoint [1] 0 0
Day 84
Secondary outcome [1] 0 0
Absolute Change From Baseline in Inflammatory Lesion Counts
Timepoint [1] 0 0
Day 84

Eligibility
Key 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.
Minimum age
12 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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, a-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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/09/2019
Sample size
Target
Accrual to date
Final
368
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cmax Clinical Research - Adelaide
Recruitment hospital [2] 0 0
The Skin Centre - Benowa
Recruitment hospital [3] 0 0
Burswood Dermatology - Burwood
Recruitment hospital [4] 0 0
Skin & Canver Foundation Inc. - Carlton
Recruitment hospital [5] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [6] 0 0
Fremantle Dermatology - Fremantle
Recruitment hospital [7] 0 0
North Eastern Health Specialist - Hectorville
Recruitment hospital [8] 0 0
St George Dermatology & Skim Cancer Center - Kogarah
Recruitment hospital [9] 0 0
Captain Sterline Medical Centre - Nedlands
Recruitment hospital [10] 0 0
Woden Dermatology - Phillip
Recruitment hospital [11] 0 0
Varacity Clinical Research - Woolloongabba
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
6100 - Burwood
Recruitment postcode(s) [4] 0 0
053 - Carlton
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
6160 - Fremantle
Recruitment postcode(s) [7] 0 0
5073 - Hectorville
Recruitment postcode(s) [8] 0 0
2217 - Kogarah
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment postcode(s) [10] 0 0
2606 - Phillip
Recruitment postcode(s) [11] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maine
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Rhode Island
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Botanix Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03573518
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anthony Robinson, CRNP
Address 0 0
Head of Development, Botanix Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03573518