Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design (CIPT)

A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design

A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design To evaluate the irritation potential of MOB015B on normal skin. Single center, randomized, controlled, evaluator blinded, within-subject comparison study

Study Overview

• Status: Completed
• Conditions: Erythema
• Intervention / Treatment: Drug: MOB015B; Drug: 0.2% SLS; Drug: 0.9% Saline; Drug: MOB015B vehicle

Detailed Description

MOB015B is a newly developed topical solution for the treatment of nail fungus (onychomycosis) containing the active antifungal ingredient terbinafine. A This study investigates the irritation potential of MOB015B under standardized conditions compared with a known irritant (0.2% SLS) and an inert control (normal saline). Because MOB015B is formulated for topical use, it is necessary to determine the potential of this product to cause irritation after repeated topical application to the skin.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

A subject will be considered eligible for participation in the study if all of the following inclusion criteria are satisfied prior to randomization:

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
7. Complete a medical screening procedure; and
8. Read, understand, and sign an informed consent.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MOB015B, MOB015B vehicle, 0.2% SLS and an inert control; All subjects will receive MOB015B, MOB015B vehicle, 0.2% SLS (positive control) and inert control (negative control) Each subject will serve as his or her own control	Drug: MOB015B; Topical formulation; Drug: 0.2% SLS; Positive control; Drug: 0.9% Saline; Negative control; Drug: MOB015B vehicle; Topical formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the potential of MOB015B to cause skin irritation after repeated topical application to the healthy skin of humans under controlled conditions.	The mean cumulative irritation score	22 days
To assess safety	Safety was assessed by evaluation of any AEs reported during the study.	22 days

Collaborators and Investigators

• Sponsor: Moberg Pharma AB
• Investigators: Principal Investigator: Jonathan S Dosik, MD, TKL Research

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2017
• Primary Completion (Actual): November 14, 2017
• Study Completion (Actual): November 14, 2017

Study Registration Dates

• First Submitted: August 1, 2017
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Erythema
• Other Study ID Numbers: MOB015B-V

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No