Cutaneous WartsPhase 1NCT03846648
CyPep-1 in Cutaneous Warts
A Phase 1 study testing Cypep-1 in people with Cutaneous Warts, run by Centre for Human Drug Research, Netherlands at 1 site in Netherlands.
Trial summary
This Phase 1 study is intended to explore the safety, tolerability, pharmacodynamics and efficacy of topical CyPep-1 as a potential treatment for HPV-associated conditions. Since this is a first-on-human study of a topical formulation, the first subjects will be monitored more frequently in order to establish the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cutaneous Warts
- What is being tested?
- Cypep-1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Mar 2019to 20 Dec 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive. (Healthy status is defined by absence of evidence of any clinical significant/uncontrolled active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs,12-lead ECG, haematology, blood chemistry, and urinalysis);
- Body mass index (BMI) between 18 and 35 kg/m2, inclusive;
- Free of clinically significant systemic or dermatologic disorders, which, in the opinion of the investigator, will interfere with the study results or increase the risk of Adverse Events;
- Have at least 1 (non-peri/subungual) common wart on the, preferably, dorsal/palmar side of the hand / fingers which is 3-10 mm (inclusive) in diameter in its longest dimension on the plane of the skin;
- If female of childbearing potential, have a negative urine pregnancy test at Screening/Day 0, and are willing to use effective contraception during the study (i.e. oral, implanted, injectable, IUD, diaphragm, condom, tubal ligation, abstinence, or are in a monogamous relationship with a partner who has had a vasectomy);
- Able to participate and willing to give written informed consent and to comply with the study restrictions;
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- Ability to communicate well with the investigator in the Dutch language;
- Willing to refrain from using cosmetics or other topical products in the treatment area for the duration of the study;
- Agree not to use wart-removing products (prescription or over-the-counter) in the target area or prohibited medications other than the study medication during the course of the study.
Who cannot join
- Any clinically significant abnormality as determined by medical history taking and physical examinations obtained during the screening visit that in the opinion of the investigator would interfere with the study objectives or compromise subject safety;
- Not willing to use effective (double barrier) contraception until at least 3 months after last study drug application;
- For women: a positive pregnancy test and/or breastfeeding at screening or women who plan to become pregnant;
- A positive test for drugs of abuse at screening;
- History of alcohol or illicit drug abuse (alcohol abuse defined as alcohol consumption > 21 units/week);
- Positive test results for Hepatitis B, Hepatitis C or HIV;
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- Have used salicylic acid or any other over-the-counter wart-removing product including cryotherapy in the treatment area within 28 days prior to first study drug application;
- Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) within 60 days prior to first study drug application or during the course of the study. Routine use of inhaled or intranasal corticosteroids during the study is allowed;
- Have any current and / or recurrent clinical significant skin infection in the treatment area other than common warts;
- Have a known sensitivity to any of the investigational product ingredients;
- Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year;
- Donation of blood or blood loss of >500 mL within 3 months prior to screening or donation of plasma within 14 days
- Not having a general practitioner;
- Not willing to give permission to have the general practitioner to be notified upon participation in this study;
- Any condition that in the opinion of the investigator would complicate or compromise the study or the well-being of the subject.
- Part 2 only:
- Have treatment resistant / persistent warts as defined as one of the following:
- More than 5 different failed treatments including topical formulations and cryotherapy
- Longer than 6 years presence of the target wart
- Having received active treatment in a clinical trial with an experimental drug for cutaneous warts.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Centre for Human Drug Research
Leiden, South Holland, 2333 CL
About this study
Official title: A Randomized, Placebo-controlled, Double-blind Phase I Study to Explore Safety, Tolerability and Pharmacodynamics of CyPep-1 in Subjects With Cutaneous Warts
This Phase 1 study is intended to explore the safety, tolerability, pharmacodynamics and efficacy of topical CyPep-1 as a potential treatment for HPV-associated conditions. Since this is a first-on-human study of a topical formulation, the first subjects will be monitored more frequently in order to establish the safety profile. Because clinical outcomes (i.e. reduction/clearance of the lesion) often require lengthy treatment / observation periods, the study design will primarily utilize clinical measurements of wart dimensions, along with HPV viral load as a biomarker of anti-viral effect.
Read the detailed description
This study has a phase 1, randomized, vehicle-controlled, double-blind, single center design to explore the safety, tolerability and pharmacodynamics (PD) of topically applied CyPep-1 in otherwise healthy patients with cutaneous warts.
The study will entail two parts. Part 1 will follow a target area of 5x5 cm healthy skin to study tolerability and safety of the formulation. During this study part also a maximum of 3 common warts, preferably at the dorsal or palmar side of the hand / finger(s), will be treated. Several assessments will be done to determine pharmacodynamics and to explore possible efficacy after a treatment period of 1 week.
Part 2 will evaluate the pharmacodynamics and efficacy of CyPep-1 after a treatment period of 4 weeks. Study part 2 will commence after an interim analysis, e.g. a blind data review, of study part 1 has been conducted.
- Conditions
- Cutaneous Warts
- Being tested
- Cypep-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cypep-1Drug
Eligible subjects will be randomized to one of the two treatment groups in a ratio of 1:1 (active:placebo).
The treatment groups are:
- CyPep-1 topical formulation 1% (w/w)
- Vehicle topical formulation (placebo) The minimum set of studied warts is 1 treated common wart per subject. The subjects will be randomly assigned to treatment. During the treatment period topical formulation will be applied daily on to a maximum of 3 warts. One selected wart will serve as target wart, i.e. the primary wart, for detailed analysis. Selection of warts will be based on the feasibility to conduct treatment application and pharmacodynamics (including biopsy sampling) on the region of interest.
| Study group | Role | What they receive |
|---|---|---|
| Cypep-1 | Active comparator | CyPep-1 cream 1% (w/w) will be applied once daily on a 5x5 cm healthy skin area on the upper back and on 1 to max 3 common warts on the (dorsal/palmar) side of the hand.
In Part 1 the dosing will be performed once daily for 7 days. The dose of 200 μL CyPep-1 cream will be applied on a 5x5 cm on the back by clinical staff. In addition, up to 3 common warts will be treated with 20 μL of the CyPep1 cream per day.
In Part 2 subjects will administer 20-30 mg CyPep-1 cream once daily at home after instruction by clinical staff. The total treatment period will be 28 days, possibility of a maximum extension of three days is allowed. Receives: Drug: Cypep-1 |
| Placebo | Placebo comparator | Placebo cream (the same as that of the drug product CyPep-1 1% (w/w) but without the active substance) will be applied once daily on the same areas as described above. Receives: Drug: Cypep-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in heart rate
Part 1:
Heart rate (number of pulses/min) will be measured during the time points described below.
Measured: Part 1: Baseline, 0.5h, 2h, 4h, 8h, 24h, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21. Part 2: All study visits.
Changes in blood pressure (systolic and diastolic)
Blood pressure (mmHg) will be measured during the time points described below.
Measured: Part 1: Baseline, 0.5h, 2h, 4h, 8h, 24h, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21. Part 2: All study visits.
Changes in body temperature
Body temperature (degrees Celsius) will be measured during the time points described below.
Measured: Part 1: Baseline, 0.5h, 2h, 4h, 8h, 24h, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21. Part 2: All study visits.
Recording of (S)AEs
AEs and AEs will be recorded during all visits.
Measured: At all study visits.
Secondary outcomes (2)
Changes in wart size
Wart size (in mm) will be measured during the time points described below.
Measured: Part 1: Baseline, 24h,Day 3, Day 5, Day 7, Day, 14 and Day 21, Part 2: all study visits
HPV viral load
Part 1:
Swabs will be obtained every 48h during treatment period and at the FU visits.
Part 2:
Swabs will be obtained at all study visits.
Measured: 24-48h during Part 1, 1-6 weeks during Part 1 and Part 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start11 Mar 2019
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous WartsStudies 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
- Model description
- Randomized, placebo-controlled, double-blind phase I study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Human Drug Research, Netherlands
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clintrials CHDR, Centre for Human Drug Research, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846648
- Sponsor's protocol ID
- CHDR1803
- Other IDs
- NL67664.056.18
- Status last verified
- Aug 2021
- First submitted
- 25 Jan 2019
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind Phase I Study to Explore Safety, Tolerability and Pharmacodynamics of CyPep-1 in Subjects With Cutaneous Warts
- ClinicalTrials.gov ID
- NCT03846648
- Acronym / sponsor ID
- CHDR1803
- Conditions
- Cutaneous Warts
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Centre for Human Drug Research, NetherlandsUniversity, hospital or other
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 19 Feb 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.
This Phase 1 study is intended to explore the safety, tolerability, pharmacodynamics and efficacy of topical CyPep-1 as a potential treatment for HPV-associated conditions. Since this is a first-on-human study of a topical formulation, the first subjects will be monitored more frequently in order to establish the safety profile. Because clinical outcomes (i.e. reduction/clearance of the lesion) often require lengthy treatment / observation periods, the study design will primarily utilize clinical measurements of wart dimensions, along with HPV viral load as a biomarker of anti-viral effect.
Detailed description
This study has a phase 1, randomized, vehicle-controlled, double-blind, single center design to explore the safety, tolerability and pharmacodynamics (PD) of topically applied CyPep-1 in otherwise healthy patients with cutaneous warts.
The study will entail two parts. Part 1 will follow a target area of 5x5 cm healthy skin to study tolerability and safety of the formulation. During this study part also a maximum of 3 common warts, preferably at the dorsal or palmar side of the hand / finger(s), will be treated. Several assessments will be done to determine pharmacodynamics and to explore possible efficacy after a treatment period of 1 week.
Part 2 will evaluate the pharmacodynamics and efficacy of CyPep-1 after a treatment period of 4 weeks. Study part 2 will commence after an interim analysis, e.g. a blind data review, of study part 1 has been conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, placebo-controlled, double-blind phase I study
| Arm | Type | Receives |
|---|---|---|
| Cypep-1 | Active comparator | Drug: Cypep-1CyPep-1 cream 1% (w/w) will be applied once daily on a 5x5 cm healthy skin area on the upper back and on 1 to max 3 common warts on the (dorsal/palmar) side of the hand. In Part 1 the dosing will be performed once daily for 7 days. The dose of 200 μL CyPep-1 cream will be applied on a 5x5 cm on the back by clinical staff. In addition, up to 3 common warts will be treated with 20 μL of the CyPep1 cream per day. In Part 2 subjects will administer 20-30 mg CyPep-1 cream once daily at home after instruction by clinical staff. The total treatment period will be 28 days, possibility of a maximum extension of three days is allowed. |
| Placebo | Placebo comparator | Drug: Cypep-1Placebo cream (the same as that of the drug product CyPep-1 1% (w/w) but without the active substance) will be applied once daily on the same areas as described above. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive. (Healthy status is defined by absence of evidence of any clinical significant/uncontrolled active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs,12-lead ECG, haematology, blood chemistry, and urinalysis);
- Body mass index (BMI) between 18 and 35 kg/m2, inclusive;
- Free of clinically significant systemic or dermatologic disorders, which, in the opinion of the investigator, will interfere with the study results or increase the risk of Adverse Events;
- Have at least 1 (non-peri/subungual) common wart on the, preferably, dorsal/palmar side of the hand / fingers which is 3-10 mm (inclusive) in diameter in its longest dimension on the plane of the skin;
- If female of childbearing potential, have a negative urine pregnancy test at Screening/Day 0, and are willing to use effective contraception during the study (i.e. oral, implanted, injectable, IUD, diaphragm, condom, tubal ligation, abstinence, or are in a monogamous relationship with a partner who has had a vasectomy);
Key exclusion criteria (20 listed)
- Any clinically significant abnormality as determined by medical history taking and physical examinations obtained during the screening visit that in the opinion of the investigator would interfere with the study objectives or compromise subject safety;
- Not willing to use effective (double barrier) contraception until at least 3 months after last study drug application;
- For women: a positive pregnancy test and/or breastfeeding at screening or women who plan to become pregnant;
- A positive test for drugs of abuse at screening;
- History of alcohol or illicit drug abuse (alcohol abuse defined as alcohol consumption > 21 units/week);
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 |
|---|---|---|
| Cypep-1Eligible subjects will be randomized to one of the two treatment groups in a ratio of 1:1 (active:placebo). The treatment groups are: * CyPep-1 topical formulation 1% (w/w) * Vehicle topical formulation (placebo) The minimum set of studied warts is 1 treated common wart per subject. The subjects will be randomly assigned to treatment. During the treatment period topical formulation will be applied daily on to a maximum of 3 warts. One selected wart will serve as target wart, i.e. the primary wart, for detailed analysis. Selection of warts will be based on the feasibility to conduct treatment application and pharmacodynamics (including biopsy sampling) on the region of interest. | Drug | Cypep-1, Placebo |
Primary outcome
Changes in heart rate
Time frame: Part 1: Baseline, 0.5h, 2h, 4h, 8h, 24h, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21. Part 2: All study visits.
Part 1: Heart rate (number of pulses/min) will be measured during the time points described below.
Changes in blood pressure (systolic and diastolic)
Time frame: Part 1: Baseline, 0.5h, 2h, 4h, 8h, 24h, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21. Part 2: All study visits.
Blood pressure (mmHg) will be measured during the time points described below.
Changes in body temperature
Time frame: Part 1: Baseline, 0.5h, 2h, 4h, 8h, 24h, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21. Part 2: All study visits.
Body temperature (degrees Celsius) will be measured during the time points described below.
Recording of (S)AEs
Time frame: At all study visits.
AEs and AEs will be recorded during all visits.
2 secondary outcomes
Changes in wart size
Time frame: Part 1: Baseline, 24h,Day 3, Day 5, Day 7, Day, 14 and Day 21, Part 2: all study visits
HPV viral load
Time frame: 24-48h during Part 1, 1-6 weeks during Part 1 and Part 2
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 3 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cypep-1 in people with Cutaneous Warts, run by Centre for Human Drug Research, Netherlands at 1 site in Netherlands.
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 9 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 3 Aug 2021. 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 Netherlands. 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?
Changes in heart rate (time frame: Part 1: Baseline, 0.5h, 2h, 4h, 8h, 24h, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21. Part 2: All study visits.). The study lists 4 primary outcomes in all. 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 3 Aug 2021.