Atopic DermatitisPhase 1NCT04544943
Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of Topical BioLexa in Adult Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis
A Phase 1 study testing BioLexa- Cohort 1, BioLexa- Cohort 2 and Gentamicin in people with Atopic Dermatitis, run by Hoth Therapeutics, Inc. at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- BioLexa- Cohort 1, BioLexa- Cohort 2 and Gentamicin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteAustralia
- Study dates
- 17 May 2021to 21 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female volunteers, aged 18 to 65 years
- 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)
- Participants must have a BMI between ≥ 18.0 and ≤ 35.0 kg/m2 at Screening; (Part A and B)
- 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)
- 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)
- Participants must have no relevant dietary restrictions, and be willing to consume standard meals provided; (Part A and B)
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- 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.
- Males must not donate sperm for at least 90 days after the last dose of study drug (Part A and B);
- Participants must have the ability and willingness to attend the necessary visits to the CRU (Part A and B);
- 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:
- Male and Female, 18 to 65 years (Cohort 2 - adult patients)
- 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;
- 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);
- Participant has a minimum of 2 AD lesions;
- Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the patient, as required by local laws;
Who cannot join
- 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)
- 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)
- 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)
- Blood donation or significant blood loss within 60 days prior to the first study drug administration; (Part A and B)
- Plasma donation within 7 days prior to the first study drug administration; (Part A and B)
- Fever (body temperature >38°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening; (Part A and B)
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- History of severe allergic or anaphylactic reactions; (Part A and B)
- Known contact sensitivity to aminoglycosides; (Part A and B)
- Contact sensitivity to BioLexa or any formulation ingredients; (Part A and B)
- 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)
- Abnormal ECG findings at Screening that are considered by the Investigator to be clinically significant; (Part A and B)
- History or presence of a condition associated with significant immunosuppression; (Part A and B)
- History of life-threatening infection (e.g. meningitis); (Part A and B)
- 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:
- 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)
- Treatment with the following topical agents within 2 weeks before the Baseline visit: corticosteroids, phosphodiesterase inhibitors, tacrolimus or pimecrolimus.
- 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
- 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
- Prior treatment with dupilumab or any antibody against IL-4Rα or IL-13 within 1 month before Baseline visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
This study will consist of 3 parts. Part A: Part A will consist of Cohort 1 constituting of heathy subjects. The total body surface area (BSA) dosed will be either 9% or 27% BSA for Cohort 1 subjects. Part A will include both an active-control (lotion base + 0.1% gentamicin) and a placebo control, applied at 9% or 27% BSA.
Part B: Part B will consist of Cohort 2 made up of adult mild to moderate AD patients. 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.
Open-Label Cohort: After closure of Part B, open-label enrolment of patients with mild to moderate atopic dermatitis affecting 3-27% BSA for treatment with BioLexa for 14 days (unblinded).
- Conditions
- Atopic Dermatitis
- Being tested
- BioLexa- Cohort 1, BioLexa- Cohort 2, Placebo, Gentamicin
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioLexa- Cohort 1Drug
Twice daily application of topical BioLexa™ lotion, administered for 14 days in adult healthy subjects
BioLexa- Cohort 2Drug
Twice daily application of topical BioLexa™ lotion, administered for 14 days in adult mild to moderate AD patients
PlaceboDrug
Twice daily (BID) application of placebo for 14 days
GentamicinDrug
Twice daily (BID) application of Gentamicin for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 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. Receives: Drug: BioLexa- Cohort 1; Drug: Placebo; Drug: Gentamicin |
| Cohort 2 | Placebo comparator | 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. Receives: Drug: BioLexa- Cohort 2; Drug: Placebo; Drug: Gentamicin |
| Open-Label | Experimental | 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 Receives: Drug: BioLexa- Cohort 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) of BioLexa™ and active control (gentamicin only)
Measured by Incidence of Treatment-Emergent Adverse Events
Measured: Measurements at Baseline till Follow-up/EOS visit (14 days) or early termination
Secondary outcomes (5)
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
Measured by the change from Baseline in the Eczema Area and Severity Index (EASI) score
Measured: Measured on Day 7, 14, 21 and 28
To evaluate the preliminary efficacy of BioLexa™ in patients with mild to moderate AD (Part B only)- by Scoring Atopic Dermatitis
Measured by the change from Baseline in Scoring Atopic Dermatitis (SCORAD) index
Measured: Measured on on Day 7, 14, 21 and 28
To characterize pharmacokinetic (PK) profile of BioLexa and active control (gentamicin only) (Part A and B)- AUC
Measured through Area under the curve (AUC)
Measured: Measurements at Baseline till the end of the study (14 days)
To characterize pharmacokinetic (PK) profile of BioLexa and active control (gentamicin only) (Part A and B)- Cmax
Measured through maximum (or peak) serum concentration (Cmax)
Measured: Measurements at Baseline till the end of the study (14 days)
To characterize pharmacokinetic (PK) profile of BioLexa and active control (gentamicin only) (Part A and B)- Tmax
Measured through time of peak concentration (Tmax)
Measured: Measurements at Baseline till the end of the study (14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start17 May 2021
- Primary completion21 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoth Therapeutics, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
- Investigators
- Oscar Cumming, Dr, Principal investigator, Novatrials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544943
- Sponsor's protocol ID
- AD-001
- Status last verified
- Nov 2022
- First submitted
- 27 Aug 2020
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04544943
- Acronym / sponsor ID
- AD-001
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hoth Therapeutics, Inc.University, hospital or other
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 17 May 2021 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will consist of 3 parts. Part A: Part A will consist of Cohort 1 constituting of heathy subjects. The total body surface area (BSA) dosed will be either 9% or 27% BSA for Cohort 1 subjects. Part A will include both an active-control (lotion base + 0.1% gentamicin) and a placebo control, applied at 9% or 27% BSA.
Part B: Part B will consist of Cohort 2 made up of adult mild to moderate AD patients. 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.
Open-Label Cohort: After closure of Part B, open-label enrolment of patients with mild to moderate atopic dermatitis affecting 3-27% BSA for treatment with BioLexa for 14 days (unblinded).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: BioLexa- Cohort 1, Drug: Placebo, Drug: GentamicinRoute 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. |
| Cohort 2 | Placebo comparator | Drug: BioLexa- Cohort 2, Drug: Placebo, Drug: GentamicinRoute 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. |
| Open-Label | Experimental | Drug: BioLexa- Cohort 1Route 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Healthy male or female volunteers, aged 18 to 65 years
- 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)
- Participants must have a BMI between ≥ 18.0 and ≤ 35.0 kg/m2 at Screening; (Part A and B)
- 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)
- 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)
Key exclusion criteria (20 listed)
- 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)
- 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)
- 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)
- Blood donation or significant blood loss within 60 days prior to the first study drug administration; (Part A and B)
- Plasma donation within 7 days prior to the first study drug administration; (Part A and B)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioLexa- Cohort 1Twice daily application of topical BioLexa™ lotion, administered for 14 days in adult healthy subjects | Drug | Cohort 1, Open-Label |
| BioLexa- Cohort 2Twice daily application of topical BioLexa™ lotion, administered for 14 days in adult mild to moderate AD patients | Drug | Cohort 2 |
| PlaceboTwice daily (BID) application of placebo for 14 days | Drug | Cohort 1, Cohort 2 |
| GentamicinTwice daily (BID) application of Gentamicin for 14 days | Drug | Cohort 1, Cohort 2 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) of BioLexa™ and active control (gentamicin only)
Time frame: Measurements at Baseline till Follow-up/EOS visit (14 days) or early termination
Measured by Incidence of Treatment-Emergent Adverse Events
5 secondary outcomes
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
Time frame: Measured on Day 7, 14, 21 and 28
To evaluate the preliminary efficacy of BioLexa™ in patients with mild to moderate AD (Part B only)- by Scoring Atopic Dermatitis
Time frame: Measured on on Day 7, 14, 21 and 28
To characterize pharmacokinetic (PK) profile of BioLexa and active control (gentamicin only) (Part A and B)- AUC
Time frame: Measurements at Baseline till the end of the study (14 days)
To characterize pharmacokinetic (PK) profile of BioLexa and active control (gentamicin only) (Part A and B)- Cmax
Time frame: Measurements at Baseline till the end of the study (14 days)
To characterize pharmacokinetic (PK) profile of BioLexa and active control (gentamicin only) (Part A and B)- Tmax
Time frame: Measurements at Baseline till the end of the study (14 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar Cumming, Dr principal investigator
Novatrials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BioLexa- Cohort 1, BioLexa- Cohort 2 and Gentamicin in people with Atopic Dermatitis, run by Hoth Therapeutics, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) of BioLexa™ and active control (gentamicin only) (time frame: Measurements at Baseline till Follow-up/EOS visit (14 days) or early termination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.