Molluscum ContagiosumEarly Phase 1NCT03336372
Picato for the Treatment of Molluscum Contagiosum in Immunocompromised Patients
A Early Phase 1 study testing Picato in people with Molluscum Contagiosum, run by Center for Clinical Studies, Texas at 1 site in United States.
Trial summary
Patients at least 18 years of age will be enrolled in the study to assess the efficacy and tolerability of Picato gel in the treatment of molluscum contagiosum. Patients must have an immunocompromised condition due to taking immunosuppressive drugs or having an inherited disease affecting the immune system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Molluscum Contagiosum
- What is being tested?
- Picato
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2017to 16 Oct 2018
- Phase
- Early 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female at least 18 years of age.
- Subject must have an immunocompromised condition due to use of immunosuppressive therapies for cancer or autoimmune disease treatment or prevention of organ transplant rejection or due to an inherited condition that affects the immune system.
- Subject has at least 10 clinically typical, visible and discrete MCs within a treatment area on either the face and/or trunk. Treatment area is defined as either:
- One contiguous treatment area of at most 100 cm2
- Two non-contiguous treatment areas totaling at most 100 cm2
- Subject must be willing to forego any other treatments of MC on the face and/or trunk, including tanning bed use and excessive sun exposure, throughout the duration of the trial.
Show all 9Show fewer
- Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods, and to comply with all study requirements.
- Female subjects of childbearing potential must have a negative urine pregnancy test prior to trial treatment.
- Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until the last follow-up visit at Week 24.
Who cannot join
- Location of the treatment area
- on the periorbital skin
- within 5 cm of an incompletely healed wound
- within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
- Previous participation in an ingenol mebutate trial.
- Treatment with ingenol mebutate gel in the treatment area within 6 months or outside of the treatment area within 30 days prior to study treatment initiation.
Show all 20Show fewer
- Receipt of the following within 90 days prior to study treatment initiation:
- interferons or interferon inducers
- any dermatologic procedures or surgeries within the treatment area
- Receipt of any topical prescription medications in the treatment area within 30 days prior to study treatment initiation.
- Lesions in the treatment area have atypical clinical appearance (e.g. giant lesions greater than 5 mm, eczematous lesions, or folliculocentric lesions).
- Active dermatologic conditions that may confound the diagnosis of MC or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, or psoriasis.
- Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a severe AE or interfere with assessments of safety and efficacy during the course of the trial, as determined by the (sub)investigator's clinical judgment.
- Known history of infection with Human Immunodeficiency Virus (HIV).
- History of melanoma.
- History of chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance as judged by the (sub)investigator.
- Known or suspected allergy or reaction to any component of the IMP formulation.
- Patients who have experienced a clinically important medical event within 90 days prior to study treatment initiation (e.g., stroke, myocardial infarction, etc).
- Pregnant, breastfeeding, or lactating women.
- Participation in any another interventional clinical trial within 30 days prior to study treatment initiation.
Trial locations and contacts
1 site in 1 country.
About this study
Patients at least 18 years of age will be enrolled in the study to assess the efficacy and tolerability of Picato gel in the treatment of molluscum contagiosum. Patients must have an immunocompromised condition due to taking immunosuppressive drugs or having an inherited disease affecting the immune system.
- Conditions
- Molluscum Contagiosum
- Being tested
- Picato
- Medical subject headings
- Molluscum Contagiosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PicatoDrug
Picato 0.05% or 0.015% topical gel applied nightly for 3 consecutive nights
| Study group | Role | What they receive |
|---|---|---|
| Picato topical gel | Experimental | Not described Receives: Drug: Picato |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clearance at Week 4
Complete clearance is defined as no clinically visible MCs in the treatment area/
Measured: 4 weeks
Secondary outcomes (3)
Partial clearance at Week 4
Partial clearance defined as at least 50% reduction in the number of clinically visible MCs in the treatment area.
Measured: 4 weeks
Percentage of subjects who sustain complete clearance of MCs in the treatment area at Week 24
Measured: 24 weeks
Percentage of subjects who clear MCs outside of the treatment area at Week 24
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start20 Dec 2017
- Primary completion8 Sep 2018
- Study completion16 Oct 2018
Why it stopped: Sponsor discontinued study on 8Sep2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molluscum ContagiosumStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Clinical Studies, Texas
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma
- Responsible party
- Sponsor
- Investigators
- Stephen K Tyring, MD, PhD, Study director, Center for Clinical Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336372
- Sponsor's protocol ID
- IIS-Picato-1386
- Status last verified
- Mar 2022
- First submitted
- 6 Nov 2017
- Last updated
- 1 Apr 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Picato for the Treatment of Molluscum Contagiosum in Immunocompromised Patients
- ClinicalTrials.gov ID
- NCT03336372
- Acronym / sponsor ID
- IIS-Picato-1386
- Conditions
- Molluscum Contagiosum
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor discontinued study on 8Sep2018
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Center for Clinical Studies, TexasUniversity, hospital or other
- Collaborators
- LEO Pharma
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 8 Sep 2018 (actual)
- Study completion
- 16 Oct 2018 (actual)
- First posted
- 8 Nov 2017 (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.
Patients at least 18 years of age will be enrolled in the study to assess the efficacy and tolerability of Picato gel in the treatment of molluscum contagiosum. Patients must have an immunocompromised condition due to taking immunosuppressive drugs or having an inherited disease affecting the immune system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Picato topical gel | Experimental | Drug: Picato |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or non-pregnant female at least 18 years of age.
- Subject must have an immunocompromised condition due to use of immunosuppressive therapies for cancer or autoimmune disease treatment or prevention of organ transplant rejection or due to an inherited condition that affects the immune system.
- Subject has at least 10 clinically typical, visible and discrete MCs within a treatment area on either the face and/or trunk. Treatment area is defined as either:
- Subject must be willing to forego any other treatments of MC on the face and/or trunk, including tanning bed use and excessive sun exposure, throughout the duration of the trial.
- Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods, and to comply with all study requirements.
Key exclusion criteria (20 listed)
- Location of the treatment area
- Previous participation in an ingenol mebutate trial.
- Treatment with ingenol mebutate gel in the treatment area within 6 months or outside of the treatment area within 30 days prior to study treatment initiation.
- Receipt of the following within 90 days prior to study treatment initiation:
- Receipt of any topical prescription medications in the treatment area within 30 days prior to study treatment initiation.
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 |
|---|---|---|
| PicatoPicato 0.05% or 0.015% topical gel applied nightly for 3 consecutive nights | Drug | Picato topical gel |
Primary outcome
Complete clearance at Week 4
Time frame: 4 weeks
Complete clearance is defined as no clinically visible MCs in the treatment area/
3 secondary outcomes
Partial clearance at Week 4
Time frame: 4 weeks
Percentage of subjects who sustain complete clearance of MCs in the treatment area at Week 24
Time frame: 24 weeks
Percentage of subjects who clear MCs outside of the treatment area at Week 24
Time frame: 24 weeks
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 1 Apr 2022.
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.
Stephen K Tyring, MD, PhD study director
Center for Clinical Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Picato in people with Molluscum Contagiosum, run by Center for Clinical Studies, Texas 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 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: withdrawn, as of the sponsor's last update on 1 Apr 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 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Complete clearance at Week 4 (time frame: 4 weeks). 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 1 Apr 2022.