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

NCT06369727 | Completed Phase 1 FDA Drug

• 1 other identifier: MOB015B-VI
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Erythema

Outcome Measures

Primary Outcomes (2)

• 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.

  6 weeks

• To assess safety

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

  6 weeks

Study Arms (3)

MOB015B

EXPERIMENTAL

Patches were applied to the infrascapular area

Drug: MOB015B

Vehicle

PLACEBO COMPARATOR

Patches were applied to the infrascapular area

Drug: MOB015B vehicle

Negative irritant solution (0.9% saline)

OTHER

Patches were applied to the infrascapular area

Drug: Negative irritant solution of 0.9% saline

Interventions

MOB015B DRUG

Topcal formulation

MOB015B

MOB015B vehicle DRUG

Topcal formulation

Vehicle

Negative irritant solution of 0.9% saline DRUG

Negative control

Negative irritant solution (0.9% saline)

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 (see Table 1);
• 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

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: NA- Safety study
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: April 17, 2024
• Study Start: October 15, 2017
• Primary Completion: February 15, 2018
• Study Completion: February 15, 2018
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

US (1)