ErythemaPhase 1RIPTNCT06369727
Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design
A Phase 1 study testing MOB015B and Negative irritant solution of 0.9% saline in people with Erythema, run by Moberg Pharma AB at 1 site in United States.
Trial summary
A Randomized, Controlled Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design To evaluate the sensitization potential Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Erythema
- What is being tested?
- MOB015B and Negative irritant solution of 0.9% saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2017to 15 Feb 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is a healthy male or female (to be confirmed by medical history);
- Is 18 years of age or older;
- In the case of a female of childbearing potential, is using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom with spermicide, diaphragm with spermicide, abstinence, partner's vasectomy, tubal ligation). Abstinence or vasectomies are acceptable if the female subject agrees to implement one of the other acceptable methods of birth control if her lifestyle/partner changes;
- In the case of a female of childbearing potential, has a negative urine pregnancy test (UPT) on Day 1 prior to randomization and are willing to submit to a UPT at the end of study (EOS);
- Is free of any systemic or dermatological disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs;
- Is of any Fitzpatrick Skin Type or race, providing the skin pigmentation will allow discernment of erythema (see Table 1);
- Complete a medical screening procedure; and
- Read, understand, and sign an informed consent.
Who cannot join
- Has any visible skin disease at the application site which, in the opinion of the Investigator, will interfere with the evaluation of the test site reaction;
- Is using systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
- Is not willing to refrain from using systemic/topical anti-inflammatory analgesics such as aspirin (81 mg daily aspirin will be allowed), Aleve, Motrin, Advil, or Nuprin for 72 hours prior to and during the study (occasional use of acetaminophen will be permitted);
- Is using medication which, in the opinion of the Investigator, will interfere with the study results (e.g. anti-inflammatory medications, antipsychotics, anticonvulsants with potential pain relief effects, immunomodulatory medications, and others);
- Is unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study;
- Has psoriasis and/or active atopic dermatitis/eczema;
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- Has a known sensitivity or allergy to constituents of the materials being evaluated;
- Is a female who is pregnant, plan to become pregnant during the study, or is breast feeding a child;
- Has damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
- Has received treatment for any type of internal cancer within 5 years prior to study entry;
- Has a history of, or are currently being treated for skin cancer and/or hepatitis;
- Has a history of, or is currently being treated for, insulin dependent diabetes;
- Has any condition that might compromise study results;
- Currently or expect to sunbathe or use tanning salons during the study;
- Is currently participating in any clinical testing;
- Has any known sensitivity to adhesives; and/or
- Has received any investigational drug(s) within 4 weeks prior to study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design
A Randomized, Controlled Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design To evaluate the sensitization potential
Read the detailed description
MOB015B is a topical solution for the treatment of nail fungus (onychomycosis) containing the active antifungal ingredient terbinafine. Terbinafine is a well-known antifungal agent that has been widely used for decades for both in topical and oral preparations and is regarded as an effective treatment of dermatophyte infections. In a phase II study, MOB015B was found to be efficacious and safe in the topical treatment of distal subungual onychomycosis. This Phase 1 study will assess the sensitization potential of MOB015B.
- Conditions
- Erythema
- Being tested
- MOB015B, MOB015B vehicle, Negative irritant solution of 0.9% saline
- Medical subject headings
- Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOB015BDrug
Topcal formulation
MOB015B vehicleDrug
Topcal formulation
Negative irritant solution of 0.9% salineDrug
Negative control
| Study group | Role | What they receive |
|---|---|---|
| MOB015B | Experimental | Patches were applied to the infrascapular area Receives: Drug: MOB015B |
| Vehicle | Placebo comparator | Patches were applied to the infrascapular area Receives: Drug: MOB015B vehicle |
| Negative irritant solution (0.9% saline) | Other | Patches were applied to the infrascapular area Receives: Drug: Negative irritant solution of 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the potential of MOB015B to induce sensitization by repeated topical application to the healthy skin of humans under controlled conditions.
Evaluation of dermal reactions at the application sites assessed clinically using a visual scale that rates the degree of erythema, edema, and other signs of cutaneous irritation.
Measured: 6 weeks
To assess safety
Evaluation of any adverse events (AEs) reported during the study.application to the healthy skin of humans.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start15 Oct 2017
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErythemaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moberg Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369727
- Sponsor's protocol ID
- MOB015B-VI
- Acronym
- RIPT
- Status last verified
- Apr 2024
- First submitted
- 1 Aug 2017
- Last updated
- 17 Apr 2024
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design
- ClinicalTrials.gov ID
- NCT06369727
- Acronym / sponsor ID
- RIPT / MOB015B-VI
- Conditions
- Erythema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Moberg Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 17 Apr 2024 (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.
A Randomized, Controlled Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design To evaluate the sensitization potential
Detailed description
MOB015B is a topical solution for the treatment of nail fungus (onychomycosis) containing the active antifungal ingredient terbinafine. Terbinafine is a well-known antifungal agent that has been widely used for decades for both in topical and oral preparations and is regarded as an effective treatment of dermatophyte infections. In a phase II study, MOB015B was found to be efficacious and safe in the topical treatment of distal subungual onychomycosis. This Phase 1 study will assess the sensitization potential of MOB015B.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MOB015B | Experimental | Drug: MOB015BPatches were applied to the infrascapular area |
| Vehicle | Placebo comparator | Drug: MOB015B vehiclePatches were applied to the infrascapular area |
| Negative irritant solution (0.9% saline) | Other | Drug: Negative irritant solution of 0.9% salinePatches were applied to the infrascapular area |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Is a healthy male or female (to be confirmed by medical history);
- Is 18 years of age or older;
- In the case of a female of childbearing potential, is using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom with spermicide, diaphragm with spermicide, abstinence, partner's vasectomy, tubal ligation). Abstinence or vasectomies are acceptable if the female subject agrees to implement one of the other acceptable methods of birth control if her lifestyle/partner changes;
- In the case of a female of childbearing potential, has a negative urine pregnancy test (UPT) on Day 1 prior to randomization and are willing to submit to a UPT at the end of study (EOS);
- Is free of any systemic or dermatological disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs;
Key exclusion criteria (17 listed)
- Has any visible skin disease at the application site which, in the opinion of the Investigator, will interfere with the evaluation of the test site reaction;
- Is using systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
- Is not willing to refrain from using systemic/topical anti-inflammatory analgesics such as aspirin (81 mg daily aspirin will be allowed), Aleve, Motrin, Advil, or Nuprin for 72 hours prior to and during the study (occasional use of acetaminophen will be permitted);
- Is using medication which, in the opinion of the Investigator, will interfere with the study results (e.g. anti-inflammatory medications, antipsychotics, anticonvulsants with potential pain relief effects, immunomodulatory medications, and others);
- Is unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study;
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 |
|---|---|---|
| MOB015BTopcal formulation | Drug | MOB015B |
| MOB015B vehicleTopcal formulation | Drug | Vehicle |
| Negative irritant solution of 0.9% salineNegative control | Drug | Negative irritant solution (0.9% saline) |
Primary outcome
To determine the potential of MOB015B to induce sensitization by repeated topical application to the healthy skin of humans under controlled conditions.
Time frame: 6 weeks
Evaluation of dermal reactions at the application sites assessed clinically using a visual scale that rates the degree of erythema, edema, and other signs of cutaneous irritation.
To assess safety
Time frame: 6 weeks
Evaluation of any adverse events (AEs) reported during the study.application to the healthy skin of humans.
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 17 Apr 2024.
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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 MOB015B and Negative irritant solution of 0.9% saline in people with Erythema, run by Moberg Pharma AB 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 8 inclusion and 17 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 17 Apr 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 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?
To determine the potential of MOB015B to induce sensitization by repeated topical application to the healthy skin of humans under controlled conditions. (time frame: 6 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 17 Apr 2024.