144 Clinical Trials for Various Conditions
The study is conducted to determine if image-based computer grading can of acne, melasma, rosacea and seborrheic dermatitis correlate well to expert based clinical severity grading.
The objective is to evaluate the tolerability, safety, and efficacy of DMT310 topical powder mixed with diluent in male and female patients with moderate to severe facial acne rosacea.
Rosacea is one of the most commonly occurring dermatoses treated by dermatologist today. Rosacea is an inflammatory condition of the skin presenting as flushing and or blushing along with redness, swelling, telangiectasia, and acne lesions. Minocycline has shown beneficial in the treatment of inflammatory acne lesions in patients with rosacea. This study is to evaluate the efficacy and tolerability of minocycline (Solodyn) alone versus minocycline (Solodyn) in combination with azelaic acid 15%(Finacea) in the treatment of rosacea.
This is a prospective, parallel group, randomized, investigator-blinded pilot study. Approximately 100 subjects will be randomized at a 3:1 ratio to Seysara (sarecycline) at a weight-based dose per label or Centrum Adult Multivitamin to take by mouth daily. The study is comprised of 5 visits: screening, baseline, week 4, week 8, and week 12. Investigators will perform rosacea IGA (Investigator Global Assessment,) inflammatory lesion count, record adverse events and con meds, and ask each subject to complete a DLQI (Dermatology Life Quality Index.)
The study evaluated the safety, tolerability, and efficacy of ACCU-D1 when applied twice daily for 12 weeks in adult participants with moderate to severe acne rosacea. Two-third of the participants received ACCU-D1 while one-third of the participants received vehicle control.
The study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of participants will receive DMT210 Gel while the other half will receive vehicle control.
This research is being done to determine the safety and tolerability of timolol in the treatment of acne and rosacea. The investigators will also look for specific biomolecular changes in acne or rosacea skin when it is exposed to timolol. Timolol is approved by the Food and Drug Administration (FDA) for the treatment of glaucoma. In dermatology, it has been used as a treatment to decrease the size of vascular (blood vessel) malformations in infant skin. Timolol is not approved for use in acne or rosacea and its use in this study is investigational. Many people with rosacea have telangiectasias which are small, red dilated blood vessels on the skin. They also suffer from flushing and acne-like lesions. Better treatments than those currently available are desired. Acne vulgaris, or acne, is another chronic inflammatory and very common skin disease that affects about 8 out of 10 young adults and adolescents. Signs of acne include papules and blackheads that are often called primary lesions because they represent an active form of the disease. There are also secondary lesions that can form later; they are known as acne scars
The pilot study will investigate whether combination treatment of Finacea 15% Gel and Brimonidine 0.33% Gel could be more effective than Brimonidine 0.33% Gel monotherapy in treating both the papules/pustules and erythema associated with rosacea.
The purpose of this open-label study is to determine the tolerance and efficacy of twice-daily application of PRK 124 (Pyratine-6)(0.125%) moisturizing lotion for improving the signs and symptoms of mild to moderate facial rosacea.
The purpose of this study is to determine whether Periostat(R), Doxycycline Hyclate 20 mg Tablets, taken twice daily is effective in reducing the red and white heads and overall redness associated with rosacea.
To demonstrate the efficacy of Clascoterone cream 1% in reducing the size of sebaceous glands in study participants with acneiform rosacea.
There are 3 main objectives of this proposal as follows: (1) to assess the efficacy of radiofrequency microneedling in the treatment of erythematotelangiectatic and or papulopustular rosacea, (2) to determine the potential for combination treatment of radiofrequency microneedling with the 532 nm KTP laser, and (3) identify potential novel therapeutic strategies for the treatment of rosacea.
This will be a double-blind, randomized placebo-controlled study in which participants will be randomized 2:1 to receive 6 mg deucravacitinib or placebo once daily for 8 weeks, followed by an open label extension during which all participants will receive 6 mg deucravacitinib once daily for an additional 8 weeks. The open-label extension has been incorporated in order to ensure all participants receive benefit from the study, as well as to benefit from the intra-patient comparison of placebo to drug, and to provide longer-term clinical data. The study will include 33 adult participants with moderate-to-severe Papulopustular Rosacea (PPR). participants will have baseline Investigator Global Assessment (IGA) score of at least 3 and at least 12 inflammatory lesions. Beginning at Baseline/Week 0 enrolled participants will receive 6mg deucravacitinib or placebo once daily for 8 weeks. At week 8, those participants originally randomized to placebo will initiate dosing with 6mg deucravacitinib once daily for 8 weeks until Week 16. Participants previously randomized to deucravacitinib will continue to receive deucravacitinib for an additional 8 weeks until Week 16. All participants will return for visits at Weeks 4, 8, 12 and 16 following study treatment initiation for repeat clinical assessments, medication reviews, tape-strip collection, blood and urine sample collections, and monitoring for adverse events.
Rosacea is a common skin condition associated with easy blushing and red face; many patients with rosacea react to sunlight with increased redness. The purpose of this study is to determine if the use of a topical medication will help reduce sunlight induced redness and irritation in patients with rosacea.
The purpose of this study is to evaluate how supplementation will alter the skin and the gut barrier and inflammation in those with rosacea.
This study is a double-blind, vehicle-controlled clinical trial. The study will take place at Icahn School of Medicine at Mount Sinai. The study will include 33-39 adult subjects with moderate-to-severe-Seborrheic dermatitis (SD) as well as 33-39 adult subjects with moderate-to-severe papulopustular rosacea (PPR). Subjects will be randomized 2:1 to receive study drug or placebo. Enrolled subjects will apply topical PF-07038124 0.02% ointment once daily for 8 weeks. They will return for visits at weeks 4, 8, and 12 following study treatment initiation for repeat clinical assessments, medication reviews, tape-strip, blood and urine sample collections, and monitoring for adverse events.
This is a prospective, vehicle controlled, double blinded study to evaluate the safety and potential efficacy of a topical formulation of a MEK inhibitor in patients with erythematotelangiectatic rosacea
10-13 patients will be enrolled to receive split face treatment: the control side will be treated with metronidazole cream, the intervention side will be treated with a cold atmospheric plasma device
This is a 16-week, multicenter, randomized, parallel-group, double-blind, controlled study. After assessing eligibility during a screening period of up to 30 days, approximately 320 subjects at least 18 years old who are diagnosed with moderate to severe papulopustular rosacea will be randomized in a 3:3:2 ratio to DFD-29 (40 mg), Doxycycline capsules 40 mg, or Placebo once daily for 16 weeks. Of the 320 subjects, approximately 160 subjects are planned to be enrolled at 15 sites in the US, while the remaining subjects are to be enrolled at 14 sites in the EU.
Ocular rosacea is an inflammatory disease of the eyelids and ocular surface. Like the facial disease, the ocular condition is chronic and recurrent. Sequelae of ocular rosacea vary from mild to severe. Ocular rosacea may cause chronic eye redness, blepharitis, recurrent chalazia, dry eye, corneal erosion, corneal vascularization, and corneal ulceration. Rosacea affecting the cornea can result in vision loss. Prescription eye drops and ointments can be used topically to control mild ocular rosacea. However, severe disease, or rosacea that is not well controlled with local treatments is treated systemically. The most commonly used systemic treatment for rosacea is the bacteriostatic antibiotic doxycycline. Rosacea treatment doses of doxycycline vary widely. Treatment-dose doxycycline for systemic infections is 100mg twice a day. However, as rosacea is considered an inflammatory disease, doxycycline is often dosed at what is termed, sub-microbial dose doxycycline (SDD). Initially introduced in the oral medicine literature, SDD are doses 40mg and lower because systemic administration at this dose does not appear to alter the oral mucosa flora or increase resistance rates when given long-term for periodontal disease. Whereas 100mg doxycycline, even when given short term, may increase the percentage of culturable nasopharyngeal flora that is resistant to doxycycline. The FDA does not categorize SDD an antibiotic, stating this dosing is expected to exhibit only anti-inflammatory activity.
This is a 16-week, multicenter, randomized, parallel-group, double-blind, controlled study. After assessing eligibility during a screening period of up to 30 days, approximately 320 subjects at least 18 years old who are diagnosed with moderate to severe papulopustular rosacea will be randomized in a 3:3:2 ratio to DFD-29 (40 mg), Doxycycline capsules 40 mg, or Placebo once daily for 16 weeks.
This is a double blind single site vehicle controlled study. The following activities will be conducted at each visit. Baseline Research Center Visit Obtain a signed and dated, written ICF prior to any study-related procedures.· Obtain demographic data· Assign subject number based on the order in which subjects present to the research center· Obtain medical/surgical history· Obtain concomitant medications· Assess eligibility based on inclusion/exclusion criteria· Collect blood and urine samples for clinical laboratory tests and send to the central laboratory· Perform serum pregnancy test in all women of child bearing potential (WOCBP)· Obtain vitals· Assess IGA, inflammation, erythema· Perform facial lesion counts· Perform local signs and symptoms assessments· Perform Columbia Suicide Severity Rating Scale (C-SSRS) for baseline visit· Randomize subject and dispense Investigational Study Medication and use instructions along with compliance diary· Schedule return visit Week 2 Phone Call· Reassess medical/surgical history· Reassess concomitant medications· Assess adverse events· Assess compliance Weeks 4, 8 Research Center Visit Reassess medical/surgical history· Reassess concomitant medications· Assess adverse events· Collect a urine sample from female subjects of childbearing potential for a urine pregnancy test· Obtain vitals· Assess IGA, inflammation, erythema· Perform facial lesion counts· Perform local signs and symptoms assessments· Perform Columbia Suicide Severity Rating Scale (C-SSRS) for return visits· Assess compliance diary and Investigational Study Medication, collect used Investigational Study Medication and redispense as necessary· Schedule return visit Week 12 Research Center Visit· Reassess medical/surgical history· Reassess concomitant medications· Assess adverse events· Collect a urine sample from female subjects of childbearing potential for a urine pregnancy test· Collect blood and urine samples for clinical laboratory tests and send to the central laboratory· Obtain vitals· Assess IGA, inflammation, erythema· Perform facial lesion counts· Perform local signs and symptoms assessments· Perform Columbia Suicide Severity Rating Scale (C-SSRS) for return visits· Assess compliance diary and Investigational Study Medication· Collect diary and Investigational Study Medication· Release subject from study participation
Rosacea is a common chronic inflammatory relapsing-remitting skin condition almost exclusively affecting the central area of the face and the eyes. Preliminary evidence suggests that treatment with rifaximin, a poorly absorbed oral antibiotic drug may be beneficial in patients with rosacea, particularly in those with papulopustular phenotype and positivity to Lactulose Breath Test (L-BT). The objective of this study is twofold: 1. To explore the safety and efficacy of 2 doses of oral Rifaximin versus placebo in adults with moderate-to-severe papulopustular rosacea. 2. To assess the pharmacokinetics (PK) of these two dose regimens in a sub-group of patients.
This is a multicenter, randomized, double-blind, vehicle-controlled, parallel design study evaluating the efficacy and safety of CGB-400 Topical Gel for the treatment of inflammatory lesions of rosacea. The study consists of a 12-week double-blind treatment period with clinic visits at Baseline (Day 0), and Weeks 2, 4, 8, and 12. Approximately 80 subjects will be enrolled and randomized at a 1:1 ratio to treatment with either CGB-400 Topical Gel (40%) BID or Vehicle Gel BID.
The primary objectives of this study are to determine the efficacy and safety of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea.
The primary hypothesis is that weekly digital interactions and routine measurement of TEWL rates and SC hydration levels will promote patient adherence to maintenance ivermectin therapy and prevent disease relapse. The project will consist of a trial in which thirty subjects with rosacea receive ivermectin therapy and are randomized to receive either no intervention, a weekly digital survey to assess patient's attitudes towards ivermectin therapy, or a portal hydration measurement device that measures TEWL rates and SC hydration levels. The study team will measure adherence objectively in all groups with electronic monitors attached to the containers of the ivermectin, which all subjects will be told to use daily for maintenance therapy. Additionally, the hydration measurement device can transmit data to an Internet server via a smartphone using Bluetooth technology, thereby allowing providers to monitor a patient's TEWL rate and SC levels.
This study will compare treatment outcome with pulsed dye laser, when used used as an adjunctive treatment to oxymetazoline HCl 1% cream, compared to oxymetazoline HCL 1% cream alone, for patients with moderate or severe erythematotelangiectatic rosacea.
The skin and gut microbiome of rosacea patients differs from individuals without rosacea and that the microbiome suffers from unique derangements in rosacea patients following antibiotic therapy. This study was proposed to examine microbial signatures of the skin and gut microbiome in patients with moderate to severe rosacea and to identify differences between microbe communities in patients with rosacea and volunteers without rosacea using 16S ribosomal ribonucleic acid (rRNA) polymerase chain reaction (PCR) amplification, sequencing and computational phylogenetics and to assess alterations in the gut and skin microbiota of patients with moderate to severe rosacea in response to varying formulations of antimicrobial treatment.
To evaluate the therapeutic equivalence and safety of ivermectin cream 1% (Zydus Worldwide DMCC) and Soolantra® (ivermectin) cream, 1% (Galderma Laboratories, L.P.) in the treatment of moderate to severe facial papulopustular rosacea. To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of moderate to severe facial rosacea.
Rosacea is a common skin disorder which causes facial redness and inflammation in about 16 million Americans, from an unknown cause. Many triggers of rosacea symptoms are stressors that affect the sympathetic ("fight or flight") portion of the nervous system, and a recent pilot study suggests there is sympathetic dysfunction in rosacea. This project will benefit patients, clinicians, and basic scientists by increasing our understanding of sympathetic nervous system involvement in rosacea symptoms in order to develop improved treatments for patients with rosacea.