Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04544943




Registration number
NCT04544943
Ethics application status
Date submitted
27/08/2020
Date registered
10/09/2020
Date last updated
17/11/2022

Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of Topical BioLexa in Adult Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis
Scientific title
A Randomised, Double-Blind, Vehicle Controlled, Sequential Group Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of Topical BioLexa in Adult Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis
Secondary ID [1] 0 0
AD-001
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 - BioLexa- Cohort 1
Treatment: Drugs - BioLexa- Cohort 2
Treatment: Drugs - Placebo
Treatment: Drugs - Gentamicin

Experimental: Cohort 1 - Route of Administration: Topical; Dosage Form: Topical lotion. Product Name: BioLexa. The total body surface area (BSA) dosed will be either 9% or 27% BSA. Part A will include both an active-control (lotion base + 0.1% gentamicin) and a placebo control, applied at 9% or 27% BSA.

Placebo Comparator: Cohort 2 - Route of Administration: Topical; Dosage Form: Topical lotion. Product Name: BioLexa. The minimum % BSA dosed will be 3% BSA and the maximum will be 27% BSA for patients in Cohort 2. Part B will include both an active-control (lotion base + 0.1% gentamicin) and a placebo control.

Experimental: Open-Label - Route of Administration: Topical; Dosage Form: Topical lotion. Product Name: BioLexa. The minimum % BSA dosed will be 3% BSA and the maximum will be 27% BSA for patients


Treatment: Drugs: BioLexa- Cohort 1
Twice daily application of topical BioLexa™ lotion, administered for 14 days in adult healthy subjects

Treatment: Drugs: BioLexa- Cohort 2
Twice daily application of topical BioLexa™ lotion, administered for 14 days in adult mild to moderate AD patients

Treatment: Drugs: Placebo
Twice daily (BID) application of placebo for 14 days

Treatment: Drugs: Gentamicin
Twice daily (BID) application of Gentamicin for 14 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) of BioLexa™ and active control (gentamicin only)
Timepoint [1] 0 0
Measurements at Baseline till Follow-up/EOS visit (14 days) or early termination
Secondary outcome [1] 0 0
To evaluate the preliminary efficacy of BioLexa™ and active control (gentamicin only) in patients with mild to moderate AD (Part B only)- by Eczema Area and Severity Index (EASI) score
Timepoint [1] 0 0
Measured on Day 7, 14, 21 and 28
Secondary outcome [2] 0 0
To evaluate the preliminary efficacy of BioLexa™ in patients with mild to moderate AD (Part B only)- by Scoring Atopic Dermatitis
Timepoint [2] 0 0
Measured on on Day 7, 14, 21 and 28
Secondary outcome [3] 0 0
To characterize pharmacokinetic (PK) profile of BioLexa and active control (gentamicin only) (Part A and B)- AUC
Timepoint [3] 0 0
Measurements at Baseline till the end of the study (14 days)
Secondary outcome [4] 0 0
To characterize pharmacokinetic (PK) profile of BioLexa and active control (gentamicin only) (Part A and B)- Cmax
Timepoint [4] 0 0
Measurements at Baseline till the end of the study (14 days)
Secondary outcome [5] 0 0
To characterize pharmacokinetic (PK) profile of BioLexa and active control (gentamicin only) (Part A and B)- Tmax
Timepoint [5] 0 0
Measurements at Baseline till the end of the study (14 days)

Eligibility
Key inclusion criteria
1. Healthy male or female volunteers, aged 18 to 65 years

2. Participants must be in good general health, with no significant medical history, have
no clinically significant abnormalities on physical examination at Screening and/or
before administration of the initial dose of study drug; (Part A)

3. Participants must have a BMI between = 18.0 and = 35.0 kg/m2 at Screening; (Part A and
B)

4. Participants must have clinical laboratory values within normal range as specified by
the testing laboratory, unless deemed not clinically significant by the Investigator
or delegate; (Part A and B)

5. Participants must be a non-smoker or a smoker who smokes no more than 2 cigarettes or
equivalent per week in order to be included in the study; (Part A and B)

6. Participants must have no relevant dietary restrictions, and be willing to consume
standard meals provided; (Part A and B)

7. Females must be non-pregnant and non-lactating, and must use an acceptable, highly
effective double contraception from screening until study completion, including the
follow-up period.

8. Males must not donate sperm for at least 90 days after the last dose of study drug
(Part A and B);

9. Participants must have the ability and willingness to attend the necessary visits to
the CRU (Part A and B);

10. Participants must be willing and able to provide written informed consent after the
nature of the study has been explained and prior to the commencement of any study
procedures (Part A and B).

In addition to the above-mentioned criteria, participants in Part B should also
fulfill the following inclusion criteria:

11. Male and Female, 18 to 65 years (Cohort 2 - adult patients)

12. Physician documented history or confirmed diagnosis of mild to moderate AD for at
least 6 months prior to screening. AD should be diagnosed by EASI score of Mild or
Moderate on Day 1;

13. Mild to moderate AD with a minimum of 3% to a maximum of 27% BSA involvement on Day 1
(excluding the scalp, designated venous access areas, palms and soles);

14. Participant has a minimum of 2 AD lesions;

15. Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by
the patient, as required by local laws;
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at
any time during the study, including the follow-up period; (Part A and B)

2. Prior or ongoing medical conditions, medical history, physical findings, or laboratory
abnormality that, in the Investigator's (or delegate's) opinion, could adversely
affect the safety of the participant; (Part A and B)

3. Presence of any underlying physical or psychological medical condition that, in the
opinion of the Investigator, would make it unlikely that the participant will comply
with the protocol or complete the study per protocol; (Part A and B)

4. Blood donation or significant blood loss within 60 days prior to the first study drug
administration; (Part A and B)

5. Plasma donation within 7 days prior to the first study drug administration; (Part A
and B)

6. Fever (body temperature >38°C) or symptomatic viral or bacterial infection within 2
weeks prior to Screening; (Part A and B)

7. History of severe allergic or anaphylactic reactions; (Part A and B)

8. Known contact sensitivity to aminoglycosides; (Part A and B)

9. Contact sensitivity to BioLexa or any formulation ingredients; (Part A and B)

10. History of malignancy, except for non-melanoma skin cancer, excised more than 2 years
ago and cervical intraepithelial neoplasia that has been successfully cured more than
5 years prior to Screening; (Part A and B)

11. Abnormal ECG findings at Screening that are considered by the Investigator to be
clinically significant; (Part A and B)

12. History or presence of a condition associated with significant immunosuppression;
(Part A and B)

13. History of life-threatening infection (e.g. meningitis); (Part A and B)

14. Infections requiring parenteral antibiotics within the 6 months prior to Screening;
(Part A and B)

In addition to the above-mentioned criteria, participants in Part B who also fulfill
the following exclusion criteria must be excluded from the study:

15. Have used antiseptic treatments (e.g. bleach baths, potassium permanganate etc.)
within 1 month before Baseline visit. (Patients who have recently used antiseptic
treatment may be rescreened at a later date if they wish to participate in the study
and agree to stop antiseptic treatment)

16. Treatment with the following topical agents within 2 weeks before the Baseline visit:
corticosteroids, phosphodiesterase inhibitors, tacrolimus or pimecrolimus.

17. Systemic treatment for AD or for condition, with steroids or other
immunosuppressive/immunomodulating substances, e.g., cyclosporine,
mycophenolate-mofetil, azathioprine or methotrexate within 4 weeks before the Baseline
visit or 5 half-lives whichever is longer. Use of steroid inhalers and nasal
corticosteroids is allowed

18. Treatment with any cell depleting agents, e.g., rituximab, within 6 months of the
Baseline visit or treatment with other biologics within 3 months of the Baseline visit

19. Prior treatment with dupilumab or any antibody against IL-4Ra or IL-13 within 1 month
before Baseline visit.

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
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
17/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/09/2022
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novatrials - Kotara
Recruitment postcode(s) [1] 0 0
2289 - Kotara

Funding & Sponsors
Primary sponsor type
Other
Name
Hoth Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 1, randomised, double-blind, vehicle controlled study to determine the
safety, tolerability, PK and efficacy of twice daily application of topical BioLexa™ lotion,
administered for 28 days in adult healthy subjects, in adult patients with mild to moderate
AD and in adolescent patients with mild to moderate AD.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04544943
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Oscar Cumming, Dr
Address 0 0
Novatrials
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/NCT04544943