Epidermal NeviPhase 2NCT05195762
12-week Study of NFX-179 Gel in Subjects With Epidermal Nevi
A Phase 2 study testing NFX-179 Gel 1.50% in people with Epidermal Nevi and Nevus Sebaceus, run by Albert Chiou at 1 site in United States.
Trial summary
This study of NFX-179 is an open-label study, evaluating safety, tolerability, pharmacodynamic activity, and the clinical effect in subjects with Epidermal Nevus(ENS). NFX-179 is formulated as a gel for topical administration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epidermal Nevi, Nevus Sebaceus
- What is being tested?
- NFX-179 Gel 1.50%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2023to Dec 2024
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, all of the following criteria must be met:
- Subject is at least 18 years of age
- Subject must provide written informed consent prior to any study procedures
- Subject has a Target Epidermal Nevi for treatment that:
- Is a documented, biopsy proven, keratinocytic epidermal nevi (KEN) or nevus sebaceous (NS) or has a 3mm punch biopsy taken for histologic examination to determine KEN or NS status
- Is a discrete lesion surrounded with at least 5mm of non-involved skin
Show all 38Show fewer
- Is not irritated
- Does not have an active cutaneous infection
- Has a Length ≥15mm
- Has a surface area ≤100cm2
- Has an Investigator's Lesion Assessment grade ≥2
- Is located at an anatomical site that the subject can reach to apply the study medication
- Has never been surgically treated
- Subject is willing to have hair in the area surrounding the Target EN shaved, if necessary, to obtain photographs
- Subject is willing to minimize exposure of the Target EN to natural or artificial ultraviolet radiation
- Subject is willing to abstain from application of non-study topical prescription and over the counter medications to the Target EN during the study
- Subject is willing to forego treatment of the Target EN, except protocol specified therapy, during the study
- Female subjects who are women of childbearing potential must have a negative urine pregnancy test result and be willing to use a protocol approved, contraceptive method for the duration of the study.
- Subject is willing and able to follow all study instructions and to attend all study visits.
- No waivers to the inclusion criteria are permitted.
- Exclusion Criteria A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Subject has applied any of the following topical products in the previous 30 days on or in proximity to the Target EN that, in the investigator's opinion, impairs evaluation of the Target EN or which exposes the subject to an unacceptable risk by study participation:
- Topical glucocorticoid steroids
- Topical retinoids (e.g., tazarotene, tretinoin, adapalene)
- > 5% of an alpha-hydroxy acid (e.g., glycolic acid, lactic acid)
- Fluorouracil
- Imiquimod
- The Target EN has ever been treated with a topical MEK inhibitor or a topical BRAF inhibitor
- The Subject has used any of the following systemic medications in the noted time period:
- Systemic retinoids (e.g., etretinate, isotretinoin) in the previous 90 days
- Systemic MEK inhibitors in the previous 180 days
- Systemic BRAF inhibitors in the previous 180 days
- Subject has a history of hypersensitivity to any of the ingredients in the study medications
- Subject has any know intercurrent illness or physical condition that would, in the investigator's opinion, impair evaluation of the Target EN or which exposes the subject to an unacceptable risk by study participation
- Subject has, in the Investigator's opinion, a clinically relevant history of liver disease, including viral hepatitis, current alcohol abuse, or cirrhosis
- Subject has a history of metastatic disease, or active cancer (excluding non-melanoma skin cancer, Stage I cervical cancer, ductal carcinoma in situ of the breast, or Stage 0 chronic lymphocytic lymphoma) within the previous 5 years
- Subject has any condition (e.g., other skin conditions or diseases, metabolic dysfunction, physical examination findings, clinical laboratory findings) or situation (e.g., vacation, scheduled surgery) that would, in the Investigator's opinion, impair evaluation of the Target EN or which exposes the subject to an unacceptable risk by study participation
- Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within the previous 30 days No waivers to the exclusion criteria are permitted.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 12-Week Clinical Study to Determine the Safety, Tolerability, and Clinical Effect of NFX-179 Gel in Subjects With Epidermal Nevi
This study of NFX-179 is an open-label study, evaluating safety, tolerability, pharmacodynamic activity, and the clinical effect in subjects with Epidermal Nevus(ENS). NFX-179 is formulated as a gel for topical administration. NFX-179 has been shown in animal studies and in human extracts to suppress p-ERK with systemic absorption of NFX-179 following topical application to be extremely low, based on serum values observed in animal studies.
Primary objectives:
Read more
- To determine the pharmacodynamic activity of NFX-179 Gel as defined by suppression of phospho-ERK (p-ERK) levels in Target EN in treatment group after 12 weeks of once-daily (QD) application
- To determine the safety and tolerability of treatment with NFX-179 Gel 1.50% applied QD for 12 weeks.
Secondary objectives:
-Clinical effect of NFX-179 Gel 1.5% defined as the percent change in EN volume after 12 weeks of QD application
Read the detailed description
This is a 12-week clinical study to determine safety, tolerability, and clinical effect of NFX-179 Gel 1.50% Gel in subjects with EN.
At Visit 1 (Screening), the Investigator will select 1 Target EN lesion for treatment that meet the inclusion criteria. A biopsy tissue sample of the Target EN will be taken for histological confirmation of an EN diagnosis if required, to assess p-ERK levels and for genetic testing.
Subjects will be seen at Visit 2 for management of the Visit 1 biopsy wounds.
At Visit 3 (Baseline) eligible subjects will be provided study medication and start the 12-week, QD treatment period. Target EN assessments will be collected.
Subjects will be seen for treatment period visits, Visits 4-7, when Target EN assessments will be collected.
At Visit 8, subjects will be seen for the final treatment period visit. Target EN assessments, a biopsy sample for genetic testing and p-ERK levels will be. Subjects will start a 4-week no-treatment follow-up period.
Subjects will be seen at Visit 9, for management of the Visit 8 biopsy wound.
At Visit 10 (end of study), subjects will be seen for the final study visit and will be discharged from the study.
- Conditions
- Epidermal Nevi, Nevus Sebaceus
- Being tested
- NFX-179 Gel 1.50%
- Medical subject headings
- Nevus, Sebaceous of Jadassohn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NFX-179 Gel 1.50%Drug
Stanford University (Stanford) is studying a selective mitogen-activated protein kinase kinase (MEK) inhibitor (NFX-179) that has been chemically engineered for topical application to treat epidermal nevus syndromes (ENS).
Preclinical studies evaluating topical application of NFX-179 to human nevus sebaceous explants demonstrated that NFX-179 can penetrate the tissue and suppress the p-ERK biomarker.
It was also determined that NFX-179, when incubated with the tissues in medium, also suppressed ERK phosphorylation in human keratinocytic epidermal nevi. This clinical study is designed to evaluate the safety, tolerability, and clinical effect of NFX-179 Gel in Subjects with Epidermal Nevi.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving NFX-179 Gel | Experimental | NFX-179 Gel 1.50% applied QD for 12 weeks Receives: Drug: NFX-179 Gel 1.50% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of dermal safety and tolerability assessments including pain/burning, pruritus, erythema, edema, scabbing/crusting, and vesiculation/erosion
To determine the safety and tolerability of treatment with NFX-179 gel applied QD for 12 weeks of treatment.
Measured: 12 weeks
The frequency of adverse events and serious adverse events as assessed by CTCAE v4.0
To determine the safety and tolerability of treatment with NFX-179 gel applied QD for 12 weeks of treatment.
Measured: 12 weeks
Secondary outcomes (2)
Change in ILA (Investigator's Lesion Assessment)
Change in Investigator's Lesion Assessment after 12 weeks of QD application, assessed at screening, baseline, treatment period at week 2, 3, 4, and 8, and end of treatment at week 12.
Measured: 12 weeks
Percent change in EN volume
Percent change in EN volume after 12 weeks of QD application as determined based on EN size derived from ruler measurements, and/or digital images from standardized photography performed at screening, baseline, treatment period at week 2, 3, 4, and 8, and end of treatment at week 12.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study startJun 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Sponsored declined to proceed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermal NeviStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, all participants will apply NFX-179 gel for 12 weeks
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Chiou
- Sponsor type
- University, hospital or other
- Collaborators
- NFlection Therapeutics, Inc.
- Responsible party
- Sponsor-investigator, Albert Chiou, Stanford University
- Investigators
- Albert S Chiou, MD, MBA, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195762
- Sponsor's protocol ID
- 60276
- Status last verified
- May 2024
- First submitted
- 13 Dec 2021
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We will only be sharing participant data with the sponsor, Nflection Therapeutics.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12-Week Clinical Study to Determine the Safety, Tolerability, and Clinical Effect of NFX-179 Gel in Subjects With Epidermal Nevi
- ClinicalTrials.gov ID
- NCT05195762
- Acronym / sponsor ID
- 60276
- Conditions
- Epidermal Nevi, Nevus Sebaceus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsored declined to proceed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Albert ChiouUniversity, hospital or other
- Collaborators
- NFlection Therapeutics, Inc.
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Jan 2022 (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 study of NFX-179 is an open-label study, evaluating safety, tolerability, pharmacodynamic activity, and the clinical effect in subjects with Epidermal Nevus(ENS). NFX-179 is formulated as a gel for topical administration. NFX-179 has been shown in animal studies and in human extracts to suppress p-ERK with systemic absorption of NFX-179 following topical application to be extremely low, based on serum values observed in animal studies.
Primary objectives:
- To determine the pharmacodynamic activity of NFX-179 Gel as defined by suppression of phospho-ERK (p-ERK) levels in Target EN in treatment group after 12 weeks of once-daily (QD) application
- To determine the safety and tolerability of treatment with NFX-179 Gel 1.50% applied QD for 12 weeks.
Secondary objectives:
-Clinical effect of NFX-179 Gel 1.5% defined as the percent change in EN volume after 12 weeks of QD application
Detailed description
This is a 12-week clinical study to determine safety, tolerability, and clinical effect of NFX-179 Gel 1.50% Gel in subjects with EN.
At Visit 1 (Screening), the Investigator will select 1 Target EN lesion for treatment that meet the inclusion criteria. A biopsy tissue sample of the Target EN will be taken for histological confirmation of an EN diagnosis if required, to assess p-ERK levels and for genetic testing.
Subjects will be seen at Visit 2 for management of the Visit 1 biopsy wounds.
At Visit 3 (Baseline) eligible subjects will be provided study medication and start the 12-week, QD treatment period. Target EN assessments will be collected.
Subjects will be seen for treatment period visits, Visits 4-7, when Target EN assessments will be collected.
At Visit 8, subjects will be seen for the final treatment period visit. Target EN assessments, a biopsy sample for genetic testing and p-ERK levels will be. Subjects will start a 4-week no-treatment follow-up period.
Subjects will be seen at Visit 9, for management of the Visit 8 biopsy wound.
At Visit 10 (end of study), subjects will be seen for the final study visit and will be discharged from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, all participants will apply NFX-179 gel for 12 weeks
| Arm | Type | Receives |
|---|---|---|
| Patients receiving NFX-179 Gel | Experimental | Drug: NFX-179 Gel 1.50%NFX-179 Gel 1.50% applied QD for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- In order to be eligible to participate in this study, all of the following criteria must be met:
- Subject is at least 18 years of age
- Subject must provide written informed consent prior to any study procedures
- Subject has a Target Epidermal Nevi for treatment that:
- Subject is willing to have hair in the area surrounding the Target EN shaved, if necessary, to obtain photographs
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| NFX-179 Gel 1.50%Stanford University (Stanford) is studying a selective mitogen-activated protein kinase kinase (MEK) inhibitor (NFX-179) that has been chemically engineered for topical application to treat epidermal nevus syndromes (ENS). Preclinical studies evaluating topical application of NFX-179 to human nevus sebaceous explants demonstrated that NFX-179 can penetrate the tissue and suppress the p-ERK biomarker. It was also determined that NFX-179, when incubated with the tissues in medium, also suppressed ERK phosphorylation in human keratinocytic epidermal nevi. This clinical study is designed to evaluate the safety, tolerability, and clinical effect of NFX-179 Gel in Subjects with Epidermal Nevi. | Drug | Patients receiving NFX-179 Gel |
Primary outcome
The frequency of dermal safety and tolerability assessments including pain/burning, pruritus, erythema, edema, scabbing/crusting, and vesiculation/erosion
Time frame: 12 weeks
To determine the safety and tolerability of treatment with NFX-179 gel applied QD for 12 weeks of treatment.
The frequency of adverse events and serious adverse events as assessed by CTCAE v4.0
Time frame: 12 weeks
To determine the safety and tolerability of treatment with NFX-179 gel applied QD for 12 weeks of treatment.
2 secondary outcomes
Change in ILA (Investigator's Lesion Assessment)
Time frame: 12 weeks
Percent change in EN volume
Time frame: 12 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 28 May 2024.
- Individual participant dataSharing planned: No. We will only be sharing participant data with the sponsor, Nflection Therapeutics.
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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.
Albert S Chiou, MD, MBA principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NFX-179 Gel 1.50% in people with Epidermal Nevi and Nevus Sebaceus, run by Albert Chiou 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 38 inclusion and 0 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 28 May 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. 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?
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?
The frequency of dermal safety and tolerability assessments including pain/burning, pruritus, erythema, edema, scabbing/crusting, and vesiculation/erosion (time frame: 12 weeks). The study lists 2 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 28 May 2024.