Ichthyosis VulgarisPhase 2NCT03173547
A Six Week Topical Cream Study for Subjects With Ichthyosis Vulgaris
A Phase 2 study testing 146-9251 cream in people with Ichthyosis Vulgaris, run by Crown Laboratories, Inc. at 7 sites in United States.
Trial summary
The objective of this study is to determine and compare the safety and efficacy of topical 146-9251 cream and vehicle cream applied twice daily for 6 weeks in subjects with moderate to severe ichthyosis vulgaris (IV). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Ichthyosis Vulgaris
- What is being tested?
- 146-9251 cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 7 sitesUnited States
- Study dates
- 25 Apr 2017to 31 Jul 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is a male or female and is at least 12 years old at the time of enrollment.
- Subject has provided written informed consent/assent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must provide informed consent for the subject. If a subject becomes 18 years of age during the study, the subject must provide written informed consent at that time to continue study participation.
- Subject and parent/guardian (if applicable) are willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
- Subject has a clinical diagnosis of ichthyosis vulgaris involving a minimum of 5% body surface area (BSA). If the subject has IV involving over 40% BSA, the investigator must be able to identify a Treatment Area comprising distinct anatomic units that contains about 40% (excluding the scalp and mucosal areas) as detailed in Section 6.2.
- Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.
- Subject is in good general health and free of any disease state or physical condition that might impair evaluation of IV or which, in the investigator's opinion, exposes the subject to an unacceptable risk by study participation.
- Females must be post-menopausal, surgically sterile, or use an effective method of birth control. , Women of childbearing potential (WOCBP) must have with a negative urine pregnancy test (UPT) at the Baseline Visit.
Who cannot join
- 1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
- 2. Subject is currently enrolled in an investigational drug or device study. 3. Subject has used an investigational drug or investigational device treatment within 30 days prior to first application of the test article.
- 4. Subject has used any topical therapy, including topical corticosteroids or retinoids, in the Treatment Area within 2 weeks prior to the initiation of treatment. Note: a bland emollient may be used in the Treatment Area up to 3 days prior to the initiation of treatment.
- 5. Subject has used systemic corticosteroids within 4 weeks or retinoids within 24 weeks prior to the initiation of treatment.
- 6. Subject has stable use of vitamin or herbal supplements for less than 2 weeks prior to the initiation of treatment.
- 7. Subject has a history of sensitivity to any of the ingredients in the test articles.
- 8. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
- 9. Subject has a physical condition or other dermatologic disorders (e.g., atopic, seborrheic or contact dermatitis, psoriasis, tinea infections, etc.) which, in the investigator's opinion, might impair evaluation of IV, or which exposes the subject to unacceptable risk by study participation.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Crown Investigative Site 05
Albuquerque, New Mexico, 87106
Crown Investigative site 04
Columbia, Missouri, 65212
Crown Investigative site 02
Fridley, Minnesota, 55432
Crown Investigative site 06
High Point, North Carolina, 27262
Crown Investigative site 08
Metairie, Louisiana, 70006
Crown Investigative site 07
Plainfield, Indiana, 46168
Crown investigative site 01
San Diego, California, 92123
About this study
Official title: A Randomized, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of 146-9251 Cream Applied Twice-daily for Six Weeks in Subjects With Ichthyosis Vulgaris
The objective of this study is to determine and compare the safety and efficacy of topical 146-9251 cream and vehicle cream applied twice daily for 6 weeks in subjects with moderate to severe ichthyosis vulgaris (IV).
- Conditions
- Ichthyosis Vulgaris
- Being tested
- 146-9251 cream, Vehicle cream
- Medical subject headings
- Ichthyosis Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
146-9251 creamDrug
146-9251 cream contains an active drug and is applied topically.
Vehicle creamDrug
Vehicle cream does not contain an active drug and is applied topically.
| Study group | Role | What they receive |
|---|---|---|
| 146-9251 cream | Active comparator | Topical cream to be applied two times daily to specified treatment areas for 6 weeks. Receives: Drug: 146-9251 cream |
| Vehicle cream | Placebo comparator | Topical cream to be applied two times daily to specified treatment areas for 6 weeks. Receives: Drug: Vehicle cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success
Number of participants that show at least a 2 level improvement of overall severity of disease (as measured by IGA score) at 6 weeks. The IGA score is a static evaluation of the overall or "average" degree of severity of a participant's disease, taking into account all of the participant's scaling, erythema, and fissuring in the Treatment Area. IGA was assessed using the following 5-point scale: clear (0), almost clear (1), mild (2), moderate (3), or severe (4).
Measured: Day 43 (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start25 Apr 2017
- Primary completion30 Apr 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ichthyosis VulgarisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crown Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173547
- Sponsor's protocol ID
- 146-9251-201
- Status last verified
- Aug 2021
- First submitted
- 30 May 2017
- Last updated
- 10 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of 146-9251 Cream Applied Twice-daily for Six Weeks in Subjects With Ichthyosis Vulgaris
- ClinicalTrials.gov ID
- NCT03173547
- Acronym / sponsor ID
- 146-9251-201
- Conditions
- Ichthyosis Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Crown Laboratories, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 2 Jun 2017 (actual)
- Results
- Posted 14 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine and compare the safety and efficacy of topical 146-9251 cream and vehicle cream applied twice daily for 6 weeks in subjects with moderate to severe ichthyosis vulgaris (IV).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Placebo controlled
| Arm | Type | Receives |
|---|---|---|
| 146-9251 cream | Active comparator | Drug: 146-9251 creamTopical cream to be applied two times daily to specified treatment areas for 6 weeks. |
| Vehicle cream | Placebo comparator | Drug: Vehicle creamTopical cream to be applied two times daily to specified treatment areas for 6 weeks. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is a male or female and is at least 12 years old at the time of enrollment.
- Subject has provided written informed consent/assent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must provide informed consent for the subject. If a subject becomes 18 years of age during the study, the subject must provide written informed consent at that time to continue study participation.
- Subject and parent/guardian (if applicable) are willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
- Subject has a clinical diagnosis of ichthyosis vulgaris involving a minimum of 5% body surface area (BSA). If the subject has IV involving over 40% BSA, the investigator must be able to identify a Treatment Area comprising distinct anatomic units that contains about 40% (excluding the scalp and mucosal areas) as detailed in Section 6.2.
- Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.
Key exclusion criteria (8 listed)
- 1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
- 2. Subject is currently enrolled in an investigational drug or device study. 3. Subject has used an investigational drug or investigational device treatment within 30 days prior to first application of the test article.
- 4. Subject has used any topical therapy, including topical corticosteroids or retinoids, in the Treatment Area within 2 weeks prior to the initiation of treatment. Note: a bland emollient may be used in the Treatment Area up to 3 days prior to the initiation of treatment.
- 5. Subject has used systemic corticosteroids within 4 weeks or retinoids within 24 weeks prior to the initiation of treatment.
- 6. Subject has stable use of vitamin or herbal supplements for less than 2 weeks prior to the initiation 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 |
|---|---|---|
| 146-9251 cream146-9251 cream contains an active drug and is applied topically. | Drug | 146-9251 cream |
| Vehicle creamVehicle cream does not contain an active drug and is applied topically. | Drug | Vehicle cream |
Primary outcome
Treatment Success
Time frame: Day 43 (6 weeks)
Number of participants that show at least a 2 level improvement of overall severity of disease (as measured by IGA score) at 6 weeks. The IGA score is a static evaluation of the overall or "average" degree of severity of a participant's disease, taking into account all of the participant's scaling, erythema, and fissuring in the Treatment Area. IGA was assessed using the following 5-point scale: clear (0), almost clear (1), mild (2), moderate (3), or severe (4).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 146-9251 cream in people with Ichthyosis Vulgaris, run by Crown Laboratories, Inc. at 7 sites 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 7 inclusion and 8 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 10 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 7 sites 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 14 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Success (time frame: Day 43 (6 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 10 Aug 2021.