Clinical trials: Irritation
Menopause, Healthy Female Participants
A Study to Assess the Skin Irritation and Sensitization of Estradiol/Levonorgestrel TDS in Healthy Postmenopausal Subjects
The two products used in this study are transdermal patches that contain selegiline. The test drug is the Estradiol/Levonorgestrel Transdermal Delivery System (TDS). The comparator drug is the Climara Pro® TDS.
- Trial name
- NCT07794150
- Testing
- Estradiol/Levonorgestrel Transdermal System
- Where
- 2 sites in United States, India
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Corium Innovations, Inc.
Healthy
Dermal Cumulative Irritant Patch Study
A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of FMX-101 in Healthy Volunteers Using a Cumulative Irritant Patch Test Design
- Trial name
- NCT04064125
- Testing
- FMX-101
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Vyne Therapeutics Inc.
Skin Care
To Assess the Cutaneous Irritation and Sensitization Potential of a Cosmetic Facial Product Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Participants
The objective of this clinical study is to assess the irritation and sensitisation potential of a cosmetic test product after repeated semi-occlusive patch applications to healthy human participants by following a conventional…
- Trial name
- NCT03175562
- Testing
- Facial micellar cleanser, Saline Solution: Sodium Chloride (NaCl; 0.9%)
- Where
- Brazil
- Volunteers
- 272 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Irritable Bowel Syndrome
Effect of Two Different Rye Bread Types in Irritable Bowel Syndrome
The purpose of this study is to evaluate if low-FODMAP (Fermented Oligo-, Di-, Monosaccharides And Polyols) rye bread is better tolerated in irritable bowel syndrome than commonly available traditional rye bread higher in FODMAP…
- Trial name
- NCT02161120
- Testing
- Traditional Finnish rye bread, Low FODMAP rye bread
- Where
- Finland
- Volunteers
- 87 people
- Sponsor
- Oy Karl Fazer Ab
Hygiene
Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Safety.
To prove the safety in normal conditions of use.
- Trial name
- NCT00785850
- Testing
- Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower
- Where
- Brazil
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Sanofi
Diarrhea-predominant Irritable Bowel Syndrome
Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) With LACTEOL® 340 mg
Irritable bowel syndrome is a complex condition with a high unmet medical need for effective and safe treatment options. Lacteol® is a lactobacillus product used for adjunctive and symptomatic treatment of diarrhea.
- Trial name
- NCT01358708
- Testing
- LACTEOL® 340 mg
- Where
- 8 sites in France, Germany
- Volunteers
- 26 people
- Sponsor
- Forest Laboratories
IBS - Irritable Bowel Syndrome, Anxiety
Study to Evaluate the Efficacy of Arrae's Bloat & Calm Alchemy Capsules to Reduce Bloating, Heartburn and Gas, and Alleviate the Intensity of IBS Symptoms
This is an open-label observational crossover trial to study the efficacy of a commercial dietary supplement and its effect on common symptoms of IBS (such as bloating, gas, heartburn, and other symptoms).
- Trial name
- NCT05197413
- Testing
- Arrae bloat supplement
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Arrae
Atopic Dermatitis (AD)
Tolerance Evaluation of a Nighttime Moisturizing Balm on Babies and Adults With Eczema
The purpose of this 14-day, two phase clinical study is to test the tolerance of a new over-the-counter moisturizing balm on subjects with eczema.
- Trial name
- NCT02357940
- Testing
- Experimental Product
- Where
- 2 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
Inflammatory Bowel Disease
Food-effect, Drug-Drug Interaction (DDI), and Formulation Bridging Study
This is a Phase 1, open-label, 2-cohort, food-effect, DDI, and formulation bridging study.
- Trial name
- NCT03555617
- Testing
- TD-1473, Itraconazole
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Vulvo Vaginal Atrophy (VVA)
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Study Objectives: Primary: To assess the safety, tolerability, and systemic pharmacokinetics (PK) of AZU-101 Secondary: To evaluate efficacy of daily vaginal doses of AZU-101 in postmenopausal women on vaginal epithelium
- Trial name
- NCT06197568
- Testing
- Lasofoxifene Tartrate
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Azure Biotech Inc.
Skin Health
Effect of Baby Wipe Solutions on Fecal Enzyme-induced Irritation
This is a single-center, prospective, single-blind pilot study to determine baby wipe formulations on an adult dermatitis model.
- Trial name
- NCT03346447
- Testing
- Artificial Fecal Enzyme
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Kimberly-Clark Corporation
Irritable Bowel Disease
Assessing Uniqueness of Inflammatory Bowel Disease Related Microbiome-derived Biomarkers
To assess the differential expression of IBD-related microbiome-derived biomarkers including bacterial strains and peptides such as antimicrobial peptides (AMP) found in inner-colonic samples (HygiSample™) in comparison to home…
- Trial name
- NCT05640583
- Testing
- Hygieacare System
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- HyGIeaCare, Inc.
Healthy, Atopic Dermatitis
A Study of Crisaborole Ointment 2% in Adult Japanese Healthy Subjects and Adult Japanese Subjects With Mild To Moderate Atopic Dermatitis
This is a Phase 1 parallel-cohort study of crisaborole ointment 2% to evaluate the skin irritation potential in adult Japanese healthy subjects in Cohort 1, and to evaluate the safety, tolerability and PK in adult Japanese…
- Trial name
- NCT03260595
- Testing
- Crisaborole ointment 2%, Vehicle
- Where
- Japan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hygiene
Dermacyd Femina (Lactic Acid) - Photo Dermatological Evaluation of the Irritation and Sensitivity Potential.
To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina.
- Trial name
- NCT00705744
- Testing
- Lactic acid (Dermacyd Femina)
- Where
- Brazil
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Sanofi
Irritation/Irritant
Study in Elderly Alzheimer's Patients to Assess Skin Tolerability, Irritation With 3, 7-Day Applications of DTP-System
This study is designed to assess skin tolerability, skin irritation, and adhesion of the 350 mg Donepezil Transdermal Patch (DTP-system), following 3, 7-day applications to 3 specific areas of the body (upper back, upper middle…
- Trial name
- DTP-System (NCT00916383)
- Testing
- 350 mg Donepezil Transdermal Patch
- Where
- 7 sites in United States
- Volunteers
- 49 people
- Sponsor
- Teikoku Pharma USA, Inc.
Myalgic Encephalomyelitis, Chronic Fatigue Syndrome
Effect of Probiotics in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a neurological disease. Currently there is no effective treatment for ME/CFS due to unclear etiology of the disease.
- Trial name
- NCT04741841
- Testing
- GutMagnific™ H., GutMagnific™ L.
- Where
- Sweden
- Volunteers
- 74 people
- Sponsor
- ImmuneBiotech Medical Sweden AB
Small Intestinal Bacterial Overgrowth, SIBO
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
The goal of this study is to test the effect of a probiotic formulation on gastrointestinal symptoms, gut and small intestine microbiota in participants suffering from small intestinal bacterial overgrowth (SIBO).
- Trial name
- NCT06317441
- Testing
- Probiotic
- Where
- Canada
- Volunteers
- 105 people
- Sponsor
- Nimble Science Ltd.
Irritable Bowel Syndrome With Diarrhea
A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)
This study will evaluate the effects of ORP-101 versus placebo on stool consistency and abdominal pain in patients with Irritable Bowel Syndrome with Diarrhea (IBS-D).
- Trial name
- NCT04129619
- Testing
- ORP-101
- Where
- 74 sites in United States
- Volunteers
- 321 people
- Sponsor
- OrphoMed, Inc.
Healthy
Dermacyd Tina Gel Sweet Flower - Photo Evaluation
The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Tina Gel Sweet Flower.
- Trial name
- NCT00668629
- Testing
- Lactic acid (Dermacid)
- Where
- Brazil
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Sanofi
Irritable Bowel Syndrome
Administration of a Molecular Complex of Resins, Polysaccharides and Polyphenols in Irritable Bowel Syndrome.
This study is aimed to investigate the efficacy and safety of Colilen IBS, a Medical Device made of natural substances, even when taken in addition to other therapies, for the treatment of Irritable Bowel Syndrome.
- Trial name
- NCT05016024
- Testing
- Colilen IBS
- Where
- 7 sites in Germany, Italy
- Volunteers
- 71 people
- Sponsor
- Aboca Spa Societa' Agricola