Erythema Clinical Trial
— RIPTOfficial title:
A Randomized, Controlled Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design
Verified date | April 2024 |
Source | Moberg Pharma AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 250 |
Est. completion date | February 15, 2018 |
Est. primary completion date | February 15, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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: 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. |
Country | Name | City | State |
---|---|---|---|
United States | TKL Research, Inc | Fair Lawn | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Moberg Pharma AB |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | To assess safety | Evaluation of any adverse events (AEs) reported during the study.application to the healthy skin of humans. | 6 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT04290273 -
Characterisation of the Time-course Response of UV-induced Erythema
|
N/A | |
Completed |
NCT01659853 -
Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
|
Phase 3 | |
Completed |
NCT00839462 -
Efficacy of Dexpanthenol in Thermic Erythema
|
Phase 2 | |
Not yet recruiting |
NCT06016361 -
Evaluation of a Novel Amino Acid Based Moisturizing Cream as Part of the Daily Standard Skincare Regimen Recommended During Radiation Therapy
|
N/A | |
Completed |
NCT03633877 -
Durapore vs. Hy-Tape to Secure The Endotracheal Tube
|
N/A | |
Active, not recruiting |
NCT02876107 -
Carboplatin and Paclitaxel With or Without Panitumumab in Treating Patients With Invasive Triple Negative Breast Cancer
|
Phase 2 | |
Completed |
NCT06369675 -
Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design
|
Phase 1 | |
Completed |
NCT03352323 -
An Evaluation of the Reduction in Erythema in Adult Patients With Moderate to Severe Persistent Facial Erythema Associated With Rosacea
|
Phase 3 | |
Completed |
NCT03041064 -
Multiday Beach Study
|
N/A | |
Completed |
NCT02832141 -
Effect of Thoracic Spine Mobilization on Sympathetic Nervous Systems
|
||
Completed |
NCT02131636 -
Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea
|
Phase 3 | |
Completed |
NCT01636765 -
Study of Inter- and Intra-rater Reliability of the Clinician Erythema Assessment Scale
|
||
Terminated |
NCT01597921 -
A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer
|
N/A | |
Completed |
NCT01124513 -
Melanin Index in Those With Fitzpatrick Skin Phototypes I-VI
|
N/A | |
Terminated |
NCT03496584 -
Effects of Phytonutrients on Vascular Health and Skin in Obese Males
|
N/A | |
Completed |
NCT02737592 -
A Clinical Study to Evaluate the Safety of a Personal Lubricant in Healthy Female Subjects
|
N/A | |
Completed |
NCT03852563 -
A Study to Gain Information How Well Dexpanthenol Derma Cream Helps the Face Skin to Recover After Cosmetic Lasering
|
N/A | |
Completed |
NCT05300542 -
Efficacy Study of a Novel Skin Health Product to Reduce an UVB Induced Erythema
|
N/A | |
Completed |
NCT03477825 -
Pilot Study of Triphala and Rubia Cordifolia on Gut Microbiome and Skin
|
N/A | |
Completed |
NCT02490943 -
A Pilot Study of Warm and Cold Compress to Reduce Injection Site Erythema Due to Peginterferon-beta-1a in MS
|
N/A |