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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/NCT03824405




Registration number
NCT03824405
Ethics application status
Date submitted
29/01/2019
Date registered
31/01/2019
Date last updated
25/10/2022

Titles & IDs
Public title
Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis
Scientific title
A Randomized, Double-Blind, Vehicle-Controlled Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis
Secondary ID [1] 0 0
BTX.2018.003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BTX 1204
Treatment: Drugs - Vehicle

Active Comparator: BTX 1204 - BTX 1204 twice daily

Placebo Comparator: Vehicle - Vehicle twice daily


Treatment: Drugs: BTX 1204
BTX 1204 liquid formulation

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

Outcomes
Primary outcome [1] 0 0
Investigator's Global Assessment (IGA)
Timepoint [1] 0 0
Day 85

Eligibility
Key inclusion criteria
1. Subject is of either gender between 12 and 70 years of age, inclusive.

2. Subject (or parent/legal guardian) has the ability and willingness to sign a written
informed consent.

3. Subject has a diagnosis of chronic (=1 year), stable atopic dermatitis (AD)

4. Subject has = 5% and = 30% body surface area (BSA) of AD involvement excluding the
scalp and groin.

5. Subject has an Investigator's Global Assessment (IGA) score of moderate (3) atopic
dermatitis on the 5-point IGA (0-4) scale.

6. For selected photography sites, subject has a target lesion of 25 to 200 cm2 in
surface area on the trunk, upper extremities or lower extremities with a Baseline
Signs of AD score of = 6 and = 12.

7. Subject is in good general health without clinically significant hematological,
cardiac, respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or
malignant disease, as determined by the investigator.

8. Subject has suitable venous access for blood sampling.

9. Subject is able and willing to complete the study and to comply with all study
instructions and attend the necessary visits.

10. Male subjects and their partners must agree and commit to use a barrier method of
contraception throughout the study and for 90 days after last study drug application.

11. A negative urine pregnancy test result for all Women of child bearing potential
(WOCBP) at the Screening Visit and Baseline Visit.

12. Sexually active women must agree to use the following throughout the study and for 30
days after last study drug application. WOCBP who are not sexually active at Baseline
and become sexually active must identify a plan for contraception.

1. One of these highly effective contraception methods Intrauterine device (IUD);
hormonal (injections, implants, transdermal patch, vaginal ring); tubal ligation;
partner vasectomy, OR

2. Oral contraceptives WITH a barrier method (listed below), OR

3. Two barrier forms of contraception (listed below) Male or female condom;
diaphragm; cervical cap; contraceptive sponge.

13. Males subjects must refrain from sperm donation during the study treatment period and
until 90 days after last study drug application.
Minimum age
12 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Female subject who is breast feeding, pregnant, or planning to become pregnant.

2. Subject who has an IGA score of 2 (mild) or 4 (severe).

3. Subject with history of known or suspected intolerance to the drug product excipients.

4. Subject has any clinically significant active infection in the investigator's opinion.
This includes active impetigo at any AD lesion.

5. Subject has known Hepatitis-B, Hepatitis-C, or HIV infection.

6. Subject has excessive body or facial hair that would interfere with the evaluation of
safety or with the diagnosis or assessment of AD.

7. 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 AD lesions.

8. Subject has clinically significant or severe allergies that in the investigator's
opinion would interfere with participation in the study.

9. Subject has known intolerability to topical treatments e.g., reports excessive
burning/stinging or pain with use of topical treatments.

10. Subject has an active or potentially recurring skin conditions(s) other than AD that
in the investigator's opinion would interfere with participation in the study.

11. Subject has unstable AD consistent with a requirement for high-potency
corticosteroids.

12. Subject has used dupilumab (Dupixent) within 12 weeks prior to the Baseline Visit.

13. Subject has used any biologic therapy, other than dupilumab, within 28 days prior to
the Baseline Visit.

14. Subject has used systemic (oral, IV or IM) corticosteroids within 28 days prior to the
Baseline Visit. Intra-articular injection for arthroses allowed.

15. Subject has used topical anti-pruritics (e.g., PDE4 inhibitors) within 28 days prior
to the Baseline Visit.

16. If subject is taking oral antihistamines, subject has not been on a stable dose of
oral antihistamines within 28 days prior to the Baseline visit.

17. Subject has used phototherapy, tanning beds, or any other artificial light device
within 28 days prior to the Baseline Visit.

18. Subject has used topical corticosteroids within 14 days prior to the Baseline Visit.

19. Subject has used topical calcineurin inhibitors within 14 days prior to the Baseline
Visit.

20. Subjects has used barrier creams (e.g., Mimyx, Atopiclair), within 7 days prior to the
Baseline Visit.

21. Subject has an underlying disease that requires the use of interfering topical or
systemic therapy.

22. 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, acne or rosacea.

23. 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 or interfere with the subject's
participation in the study. Subjects with other dermatologic conditions, including
genetic syndromes that have an eczematous dermatitis as a component of the disease
(e.g., Netherton's) are excluded.

24. Subject has a clinically relevant history of or current evidence of abuse of alcohol
or other drugs.

25. 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.

26. Subject 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.

27. 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
4/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/03/2020
Sample size
Target
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CMAX Clincial Research - Adelaide
Recruitment hospital [2] 0 0
BurwoodDermatology - Burwood
Recruitment hospital [3] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [4] 0 0
North Eastern Health Specialists - Hectorville
Recruitment hospital [5] 0 0
Premier Specialists PTY LTD - Kogarah
Recruitment hospital [6] 0 0
St George Dermatology & Skin Cancer Center - Kogarah
Recruitment hospital [7] 0 0
Captain Stirling Medical Centre - Nedlands
Recruitment hospital [8] 0 0
The Skin Hospital - Westmead
Recruitment hospital [9] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
6100 - Burwood
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
5073 - Hectorville
Recruitment postcode(s) [5] 0 0
2217 - Kogarah
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment postcode(s) [8] 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
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Nevada
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
New Zealand
State/province [12] 0 0
Auckland
Country [13] 0 0
New Zealand
State/province [13] 0 0
Hamilton
Country [14] 0 0
New Zealand
State/province [14] 0 0
Wellington

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with
moderate AD.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03824405
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