CClinicalTrials.gg
CompletedNCT06369727RIPTUpdated Apr 17, 2024

Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design

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

Phase
Phase 1
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Erythema

Browse trials for

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Is a healthy male or female (to be confirmed by medical history);
  2. Is 18 years of age or older;
  3. 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;
  4. 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);
  5. 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;
  6. Is of any Fitzpatrick Skin Type or race, providing the skin pigmentation will allow discernment of erythema (see Table 1);
  7. Complete a medical screening procedure; and
  8. Read, understand, and sign an informed consent.

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. 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;
  3. 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);
  4. 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);
  5. Is unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study;
  6. Has psoriasis and/or active atopic dermatitis/eczema;
  7. Has a known sensitivity or allergy to constituents of the materials being evaluated;
  8. Is a female who is pregnant, plan to become pregnant during the study, or is breast feeding a child;
  9. 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;
  10. Has received treatment for any type of internal cancer within 5 years prior to study entry;
  11. Has a history of, or are currently being treated for skin cancer and/or hepatitis;
  12. Has a history of, or is currently being treated for, insulin dependent diabetes;
  13. Has any condition that might compromise study results;
  14. Currently or expect to sunbathe or use tanning salons during the study;
  15. Is currently participating in any clinical testing;
  16. Has any known sensitivity to adhesives; and/or
  17. Has received any investigational drug(s) within 4 weeks prior to study entry.
04

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
250 participants (actual)

Study arms

  • Experimental
    MOB015B

    Patches were applied to the infrascapular area

    Drug: MOB015B

  • Placebo comparator
    Vehicle

    Patches were applied to the infrascapular area

    Drug: MOB015B vehicle

  • Other
    Negative irritant solution (0.9% saline)

    Patches were applied to the infrascapular area

    Drug: Negative irritant solution of 0.9% saline

Interventions

  • DrugMOB015B

    Topcal formulation

  • DrugMOB015B vehicle

    Topcal formulation

  • DrugNegative irritant solution of 0.9% saline

    Negative control

05

What researchers measure

Primary outcomes

  1. 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

  2. To assess safety

    Evaluation of any adverse events (AEs) reported during the study.application to the healthy skin of humans.

    Time frame: 6 weeks

06

Study locations

1 site
  • TKL Research, Inc
    Fair Lawn, New Jersey 07410, United States
07

Registry details

Key details

Study ID
NCT06369727
Lead sponsor
Moberg Pharma AB
Responsible party
Sponsor
First posted
Apr 17, 2024
Start date
Oct 15, 2017
Primary completion
Feb 15, 2018
Completion
Feb 15, 2018
Last update
Apr 17, 2024

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion