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

NCT06369675 | Completed Phase 1 FDA Drug

• 1 other identifier: MOB015B-V
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Erythema

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

MOB015B, MOB015B vehicle, 0.2% SLS and an inert control

EXPERIMENTAL

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; Drug: 0.2% SLS; Drug: 0.9% Saline; Drug: MOB015B vehicle

Interventions

MOB015B DRUG

Topical formulation

MOB015B, MOB015B vehicle, 0.2% SLS and an inert control

0.2% SLS DRUG

Positive control

MOB015B, MOB015B vehicle, 0.2% SLS and an inert control

0.9% Saline DRUG

Negative control

MOB015B, MOB015B vehicle, 0.2% SLS and an inert control

MOB015B vehicle DRUG

Topical formulation

MOB015B, MOB015B vehicle, 0.2% SLS and an inert control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Moberg Pharma AB: lead

Study Sites (1)

TKL Research, Inc

Fair Lawn, New Jersey, 07410, United States

Location

MeSH Terms

Conditions

Erythema

Interventions

long-chain-aldehyde dehydrogenase; Saline Solution

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jonathan S Dosik, MD

  TKL Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: April 17, 2024
• Study Start: October 19, 2017
• Primary Completion: November 14, 2017
• Study Completion: November 14, 2017
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)