Rosacea

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Rosacea

General Purpose:

Rosacea is a chronic skin condition that affects adults. It is inflammatory in nature, and results in facial redness and the production of small, pus-filled bumps. If it is not treated properly, it can become severe over time. For most people, it occurs in cycles – flaring up for a period of weeks or months, and then diminishing over a period of time.

Rosacea can lead to emotional distress and self-consciousness, due to its cosmetic effects when flare-ups occur. No one knows for certain what causes rosacea, but most researchers believe that it most likely results from a combination of genetic and environmental factors working together.

Many people with rosacea find that their symptoms are triggered or aggravated by things such as hot or spicy foods, alcohol, extreme temperatures, sunlight, stress, exercise, and certain medications. Unfortunately there is no cure for rosacea, but many treatments are available.

However, there is no standard method of treatment preferred for patients. As such, ample research is being conducted to improve existing treatments, search for a cure, and better understand how and why rosacea develops.

What Will Rosacea Clinical Trials Be Like?

The types of procedures used in rosacea clinical trials will ultimately depend on the specific nature of the study and what aspect of rosacea is being studied. Provided below is a list of common procedures, tests, and assessments that may be incorporated into rosacea clinical trials:

  • Detailed physical examination to eliminate conditions that mimic rosacea, such as acne.
  • A questionnaire or face-to-face interview to provide details related to your history of rosacea, which may include questions related to the following:
    • Date you first experienced rosacea
    • Noticeable triggers
    • Use of cosmetic and personal hygiene products
    • Your family history of rosacea
    • Use of prescription or over-the-counter medications, including vitamins, minerals, and other dietary supplements.
    • Treatments you have attempted to use for your rosacea.
    • You may also be asked to avoid wearing lotions, perfumes, colognes, or scented make-up on the day(s) of your appointment.
    • Questionnaires to evaluate your stress level and/or emotional well-being
    • Blood tests
    • Skin biopsy
    • Photographs of your skin
    • Use of lotions, creams, oral medications, or laser light therapy

Typical Rosacea Clinical Trial Protocol:

Specific examples of clinical trials for rosacea might include the following:

  • A study in which rosacea patients are randomly assigned to receive treatment with a newly developed medication designed to target certain immune cells, or a placebo. The purpose of this study would be to test the safety and efficacy of the new drug as a treatment for rosacea.
  • A clinical trial to determine if zinc sulfate is effective at reducing the severity of rosacea in individuals with severe disease. In such a study, patients would be randomly assigned to receive treatment with either zinc sulfate or a placebo.
  • A study to determine if laser light therapy is a safe and effective means of treating rosacea in young adults. In this study, patients would be randomly assigned to receive either treatment with the laser light or a “placebo” treatment during which laser light therapy is simulated but not actively delivered. 
  • A study in which a specific dietary intervention, such as increased intake of fiber and antioxidants though the increased consumption of fresh fruits and vegetables, is effective at 1) decreasing rosacea flare-ups and 2) improving symptoms during flare-ups.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated (such as the first three examples provided above), the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know as many details as possible with regard to your specific circumstances when searching for clinical trials.  Examples of information you may want to have on hand include the following:

  • Your history of treatment for rosacea
  • Your prior and current diagnoses of any other health conditions or diseases
  • Your current medications (including vitamins, minerals, and other dietary supplements)

Suggested Search Terms:

 “rosacea treatment,” “rosacea diet,” “rosacea complications,” “rosacea scar,” “rosacea medication,” “rosacea triggers,” “rosacea environment,” “rosacea genetics,” and “rosacea vitamins.”

Current Search Term:

“Rosacea”

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A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Patients With Rosacea


Condition:   Rosacea
Interventions:   Drug: Azelaic acid (Finacea®) Foam;   Drug: Generic Azelaic Acid Foam;   Drug: Vehicle Foam
Sponsor:   Actavis Inc.
Completed


A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea


Condition:   Papulopustular Rosacea
Intervention:   Drug: FMX103 1.5%
Sponsor:   Foamix Ltd.
Enrolling by invitation


Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea


Conditions:   Rosacea;   Papulopustular Rosacea
Interventions:   Drug: 1% Topical Minocycline Gel;   Drug: 3% Topical Minocycline Gel;   Other: Topical Vehicle Gel
Sponsor:   Hovione Scientia Limited
Not yet recruiting


Characterization of the Facial and Gut Microbiome in Rosacea


Condition:   Rosacea
Intervention:   Other: comparison of twin A to twin B
Sponsor:   The Acne Cure Alliance
Not yet recruiting


EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA


Condition:   Rosacea
Intervention:   Device: Perfecta V-Beam laser
Sponsor:   Syneron Medical
Active, not recruiting


A Study of Patient Concerns and Treatment Satisfaction in Patients Being Treated With Finacea Foam for Rosacea


Condition:   Rosacea
Intervention:   Drug: Finacea Foam, (Azelaic Acid, BAY39-6251)
Sponsor:   Bayer
Active, not recruiting


Open Label Study to Assess the Effect of Secukinumab in Moderate to Severe Papulopustular Rosacea


Condition:   Papulopustular Rosacea
Intervention:   Drug: Secukinumab
Sponsor:   Anne Chang
Recruiting


Oracea Soolantra Association in Patients With Severe Rosacea


Condition:   Rosacea
Interventions:   Drug: Ivermectin 1% cream;   Drug: Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules;   Other: Oral placebo capsules
Sponsor:   Galderma
Recruiting


Efficacy of Accu-D1 in the Treatment of Acne Rosacea


Condition:   Acne Rosacea
Interventions:   Drug: ACCU-D1;   Drug: Placebo Comparator
Sponsor:   Accuitis, Inc.
Not yet recruiting


Intense Pulsed Light as an Adjunctive to Bromonidine for the Treatment of Rosacea


Condition:   Rosacea
Interventions:   Drug: Bromonide 0.33% gel;   Device: Intense Pulsed Light (M22)
Sponsor:   Rabin Medical Center
Not yet recruiting


Internet Surveys and Their Impact on Adherence for Rosacea


Condition:   Rosacea
Interventions:   Behavioral: Internet survey;   Drug: Brimonidine gel
Sponsor:   Wake Forest University Health Sciences
Completed


Azelaic Acid on Demodex Counts in Rosacea


Condition:   Rosacea
Intervention:   Drug: Azelaic acid
Sponsor:   Wake Forest University
Completed


DMT210 Topical Gel in the Treatment of Acne Rosacea


Condition:   Acne Rosacea
Interventions:   Drug: DMT210 Topical Gel 5%;   Other: Vehicle Control
Sponsor:   Dermata Therapeutics
Active, not recruiting


Genetic Basis of Rosacea


Condition:   Rosacea
Intervention:   Genetic: buccal swab
Sponsor:   Stanford University
Recruiting


Genetic Basis of Rosacea Study (Control)


Condition:   Rosacea
Intervention:   Genetic: Skin Biopsy
Sponsor:   Stanford University
Recruiting


Internet Surveys and Their Impact on Adherence to Brimonidine Topical Gel and QOL in Patients With Rosacea


Condition:   Rosacea
Interventions:   Other: internet survey;   Drug: brimonidine topical gel 0.33%
Sponsor:   Wake Forest University Health Sciences
Recruiting


MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea.


Condition:   Rosacea
Interventions:   Drug: Brimonidine 0.33% gel (Br);   Other: CD07805/47 (Br) placebo gel;   Drug: Ivermectin 1% cream (IVM);   Other: CD5024 (IVM) placebo cream
Sponsor:   Galderma
Completed


Preferences & Treatment Satisfaction Drivers in Rosacea Patients


Condition:   Rosacea
Interventions:   Drug: Azelaic Acid Gel including: Finacea (Azelaic Acid Gel 15%, BAY39-6251);   Drug: Azelaic Acid Cream;   Drug: Metronidazole gel;   Drug: Metronidazole cream;   Drug: Metronidazole Emulsion;   Drug: Metronidazole Lotion;   Drug: Brimonidine Tartrate Gel
Sponsor:   Bayer
Completed


Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea


Conditions:   Rosacea;   Papulopustular Rosacea
Interventions:   Drug: FMX-103 1.5%;   Drug: FMX-103 3%;   Drug: Vehicle foam (0%)
Sponsor:   Foamix Ltd.
Completed


Effect of CD07805/47 Gel in Rosacea Flushing


Condition:   Rosacea
Interventions:   Drug: CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo;   Drug: Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo;   Drug: CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47;   Drug: Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47
Sponsor:   Galderma R&D
Completed


Ultherapy® for the Treatment of Erythematotelangiectatic Rosacea


Conditions:   Erythematotelangiectatic Rosacea;   Rosacea
Intervention:   Device: Ulthera System Treatment
Sponsor:   Ulthera, Inc
Completed


Photodynamic Therapy for Papulopustular Rosacea


Conditions:   Rosacea;   Papulopustular Rosacea
Interventions:   Drug: Aminolevulinic acid topical solution 20%;   Device: Blu-U Light Therapy;   Other: Placebo vehicle only
Sponsors:   George Washington University;   DUSA Pharmaceuticals, Inc.
Recruiting


Combination Gel and Vascular ND in Mild to Moderate Rosacea


Condition:   Rosacea
Interventions:   Drug: Azelaic acid;   Device: Nd:Yag laser
Sponsors:   Wake Forest University Health Sciences;   Bayer
Completed


Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients


Condition:   Erythemato-telangiectatic Rosacea
Interventions:   Drug: BFH772 1% ointment;   Drug: Vehicle ointment;   Drug: Noritate® 1% cream
Sponsor:   Novartis Pharmaceuticals
Completed


Open Label Pilot Study of Apremilast in Treatment of Rosacea


Conditions:   Erythematotelangiectatic Rosacea;   Papulopustular Rosacea
Intervention:   Drug: Apremilast
Sponsors:   Julian M. Mackay-Wiggan;   Celgene Corporation
Completed

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