Papulopustular RosaceaPhase 1/2NCT03883945
A Safety and Efficacy Study to Evaluate Rosacea
A Phase 1/2 study testing AIV001 in people with Papulopustular Rosacea, run by AiViva BioPharma, Inc. at 1 site in United States.
Trial summary
To evaluate the safety, efficacy, and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with rosacea. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Papulopustular Rosacea
- What is being tested?
- AIV001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2021to Aug 2022
- Phase
- Phase 1/2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy male and/or female subjects between the ages of 18 and 65 year with rosacea, 10 to 30 papules and pustules (at least 5 lesions within the treatment area on each facial side), and < 2 nodules
- Presence of moderate to severe persistent erythema
- Total body weight >45 kg
Who cannot join
- Presence of any skin condition on the face that would interfere with the diagnosis or assessment of rosacea
- Extremely dark skin type that would confound the digital analysis of erythema (eg, Fitzpatrick Skin Type 5 or 6)
- Excessive facial hair (eg, beards, sideburns, moustaches, etc.), birthmarks, or tattoos that would interfere with diagnosis or assessment of rosacea
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception as outlined in this protocol from at least 14 days prior to start of treatment.
- Hypersensitivity or allergy to axitinib or any other component of the study treatment
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- Use within 6 months prior to baseline and during the study of oral retinoids (eg, Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
- Use within 6 weeks prior to baseline and during the study of vasodilators or α-adrenergic receptor-blocking agents.
- Use within 1 month prior to baseline and during the study of 1) topical retinoids to the face, 2) systemic antibiotics know to have an impact on the severity of facial rosacea (eg, containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim), 3) systemic corticosteroids, or 4) facial light-based therapies
Trial locations and contacts
1 site in 1 country.
United States1 site
Cosmetic Laser Dermatology
San Diego, California, 92121
About this study
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Intradermally Administered AIV001 in Subjects With Papulopustular Rosacea
To evaluate the safety, efficacy, and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with rosacea.
Read the detailed description
This is primarily a safety study to evaluate the safety of AIV001 when administered to subjects with rosacea. Exploratory efficacy measures will also be collected as well as pharmacokinetic profiles.
- Conditions
- Papulopustular Rosacea
- Being tested
- AIV001, Vehicle
- Keywords
- rosacea
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIV001Drug
intradermal injection
VehicleDrug
intradermal injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - vehicle | Placebo comparator | Subjects randomized to vehicle will receive vehicle administration to the target area. Receives: Drug: Vehicle |
| Cohort 1 - 0.033% | Active comparator | Subjects randomized to vehicle will receive AIV001 0.033% administration to the target area. Receives: Drug: AIV001 |
| Cohort 2 - vehicle | Placebo comparator | Subjects randomized to vehicle will receive vehicle administration to the target area. Receives: Drug: Vehicle |
| Cohort 2 - 0.1% | Active comparator | Subjects randomized to vehicle will receive AIV001 0.01% administration to the target area. Receives: Drug: AIV001 |
| Cohort 3 - vehicle | Placebo comparator | Subjects randomized to vehicle will receive vehicle administration to the target area. Receives: Drug: Vehicle |
| Cohort 3 - 0.3% | Active comparator | Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area. Receives: Drug: AIV001 |
| Cohort 4 - vehicle | Placebo comparator | Subjects randomized to vehicle will receive vehicle administration to the target area. Receives: Drug: Vehicle |
| Cohort 4 - 1% | Active comparator | Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area. Receives: Drug: AIV001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Adverse Events
The occurrence of adverse events will be collected and reported using MedDRA to code. Description, start and end dates, and severity will be recorded.
Measured: Day 1 through Day 84
Secondary outcomes (3)
Efficacy evaluated by the Investigator using the Investigator Global Assessment Scale
Evaluation of rosacea within the treatment area. 0 = clear (No papules and/or pustules; no or residual erythema; no or mild to moderate telangiectasia), 1 = minimal (Rare papules and/or pustules; residual to mild erythema; mild to moderate telangiectasia), 2 = mild (Few papules and/or pustules; mild erythema; mild to moderate telangiectasia), 3 = mild to moderate (Distinct number of papules and/or pustules; mild to moderate erythema; mild to moderate telangiectasia), 4 = moderate (Pronounced number of papules and/or pustules; moderate erythema; mild to moderate telangiectasia), 5 = moderate to severe (Many papules and/or pustules; occasionally with large inflamed lesions; moderate erythema; moderate degree of telangiectasia), and 6 = severe (Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate or severe erythema; moderate or severe telangiectasia). Scores of 0 or 1 are considered success.
Measured: Day 1 through Day 84
Efficacy evaluated by the Investigator by performing Inflammatory Lesion Counts
The number of inflammatory lesions is a static measure of the number of papules or pustules present within the treatment area.
Measured: Day 1 through 84
Evaluation of Erythema and Topography using Standardized Photography
Photographs using standardized equipment will be taken and uploaded onto the vendor's server. The vendor will then use proprietary software to measure the amount of redness and the topography of the lesions within the treatment area.
Measured: Day 1 through 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study startJul 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionAug 2022 (estimated)
Why it stopped: Sponsor deprioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papulopustular RosaceaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, vehicle-controlled, parallel-group, dose-escalation study evaluating study medication versus vehicle in each of 4 sequentially enrolled cohorts
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AiViva BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitchell Goldman, MD, Principal investigator, West Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883945
- Sponsor's protocol ID
- AIV001-R01
- Status last verified
- Dec 2024
- First submitted
- 16 Mar 2019
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Intradermally Administered AIV001 in Subjects With Papulopustular Rosacea
- ClinicalTrials.gov ID
- NCT03883945
- Acronym / sponsor ID
- AIV001-R01
- Conditions
- Papulopustular Rosacea
- Keywords
- rosacea
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor deprioritization
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AiViva BioPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 21 Mar 2019 (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.
To evaluate the safety, efficacy, and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with rosacea.
Detailed description
This is primarily a safety study to evaluate the safety of AIV001 when administered to subjects with rosacea. Exploratory efficacy measures will also be collected as well as pharmacokinetic profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- Randomized, double-blind, vehicle-controlled, parallel-group, dose-escalation study evaluating study medication versus vehicle in each of 4 sequentially enrolled cohorts
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - vehicle | Placebo comparator | Drug: VehicleSubjects randomized to vehicle will receive vehicle administration to the target area. |
| Cohort 1 - 0.033% | Active comparator | Drug: AIV001Subjects randomized to vehicle will receive AIV001 0.033% administration to the target area. |
| Cohort 2 - vehicle | Placebo comparator | Drug: VehicleSubjects randomized to vehicle will receive vehicle administration to the target area. |
| Cohort 2 - 0.1% | Active comparator | Drug: AIV001Subjects randomized to vehicle will receive AIV001 0.01% administration to the target area. |
| Cohort 3 - vehicle | Placebo comparator | Drug: VehicleSubjects randomized to vehicle will receive vehicle administration to the target area. |
| Cohort 3 - 0.3% | Active comparator | Drug: AIV001Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area. |
| Cohort 4 - vehicle | Placebo comparator | Drug: VehicleSubjects randomized to vehicle will receive vehicle administration to the target area. |
| Cohort 4 - 1% | Active comparator | Drug: AIV001Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male and/or female subjects between the ages of 18 and 65 year with rosacea, 10 to 30 papules and pustules (at least 5 lesions within the treatment area on each facial side), and < 2 nodules
- Presence of moderate to severe persistent erythema
- Total body weight >45 kg
Key exclusion criteria (9 listed)
- Presence of any skin condition on the face that would interfere with the diagnosis or assessment of rosacea
- Extremely dark skin type that would confound the digital analysis of erythema (eg, Fitzpatrick Skin Type 5 or 6)
- Excessive facial hair (eg, beards, sideburns, moustaches, etc.), birthmarks, or tattoos that would interfere with diagnosis or assessment of rosacea
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception as outlined in this protocol from at least 14 days prior to start of treatment.
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 |
|---|---|---|
| AIV001intradermal injection | Drug | Cohort 1 - 0.033%, Cohort 2 - 0.1%, Cohort 3 - 0.3%, Cohort 4 - 1% |
| Vehicleintradermal injection | Drug | Cohort 1 - vehicle, Cohort 2 - vehicle, Cohort 3 - vehicle, Cohort 4 - vehicle |
Primary outcome
Rate of Adverse Events
Time frame: Day 1 through Day 84
The occurrence of adverse events will be collected and reported using MedDRA to code. Description, start and end dates, and severity will be recorded.
3 secondary outcomes
Efficacy evaluated by the Investigator using the Investigator Global Assessment Scale
Time frame: Day 1 through Day 84
Efficacy evaluated by the Investigator by performing Inflammatory Lesion Counts
Time frame: Day 1 through 84
Evaluation of Erythema and Topography using Standardized Photography
Time frame: Day 1 through 84
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- 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.
Mitchell Goldman, MD principal investigator
West Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AIV001 in people with Papulopustular Rosacea, run by AiViva BioPharma, Inc. at 1 site in United States.
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 3 inclusion and 9 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: withdrawn, as of the sponsor's last update on 17 Dec 2024. 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 United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Rate of Adverse Events (time frame: Day 1 through Day 84). 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 Dec 2024.