Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test D… (NCT06369675) | Clinical Trial Compass
CompletedPhase 1
Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design
United States45 participantsStarted 2017-10-19
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;
What they're measuring
1
To determine the potential of MOB015B to cause skin irritation after repeated topical application to the healthy skin of humans under controlled conditions.
✕. 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;