A Phase 1 interventional study of MOB015B and MOB015B vehicle in Erythema, sponsored by Moberg Pharma AB. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Moberg Pharma AB · Phase 1, Interventional, and Other
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
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.
131 studies on the registry are indexed under Erythema; 17 are open to participants now.
This study's enrollment of 250 is above the median of 50 across 114 interventional studies indexed under Erythema.
Browse Erythema studies →Moberg Pharma AB is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patches were applied to the infrascapular area
Drug: MOB015B
Patches were applied to the infrascapular area
Drug: MOB015B vehicle
Patches were applied to the infrascapular area
Drug: Negative irritant solution of 0.9% saline
Topcal formulation
Topcal formulation
Negative control
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.
Time frame: 6 weeks
To assess safety
Evaluation of any adverse events (AEs) reported during the study.application to the healthy skin of humans.
Time frame: 6 weeks
Ran from Oct 2017 to primary completion in Feb 2018, 4 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Terbinafine
Moberg Pharma AB