Status:
COMPLETED
Combination Therapy for the Treatment of Rosacea
Lead Sponsor:
Ellen Marmur
Collaborating Sponsors:
American Society for Laser Surgery and Medicine
Conditions:
Erythematotelangiectatic Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the efficacy of calcium dobesilate in combination with pulsed dye laser for the treatment of rosacea.
Detailed Description
Rosacea is a common cutaneous disorder characterized by facial erythema, papules and pustules and telangiectasias. The clinical manifestations of this disorder are distributed along the convexities of...
Eligibility Criteria
Inclusion
- Must understand and voluntarily sign an informed consent form.
- Must be male or female and aged ≥ 18 years at time of consent.
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Must have clinically typical confirmed diagnosis of erythematotelangestatic rosacea.
- Females of childbearing potential (FCBP)‡ must have one negative urine pregnancy tests at screening. In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception while on study medication: oral, injectable, or implantable hormonal contraceptives; tubal ligation; intrauterine device; barrier contraceptive with spermicide; or vasectomized partner while on the study. A FCBP must agree to have pregnancy tests every 4 weeks while on study medication.
- Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in sexual activity with FCBP while on study medication.
Exclusion
- Inability to provide voluntary informed consent.
- Pregnant or breastfeeding female.
- A skin examination reveals the presence of another skin disease and/or condition (excessive facial hair, excessive scarring, sunburn, or other disfigurement) located on the face that would confound the evaluation of the rosacea.
- Current or past ocular rosacea, such as conjunctivitis, iritis and keratitis of sufficient severity to require topical or systemic antibiotics.
- Subjects with recurrent gastritis, renal dysfunction or ulcer disease (peptic or duodenal).
- Treatment with topical antibiotics, topical steroids, topical retinoids and other topical rosacea treatments on the face within 14 days of baseline and throughout the study.
- Treatment with any systemic medication or therapy known to affect inflammatory responses within the 30 days prior to baseline and throughout the study.
- Treatment with systemic retinoids within 6 months prior to study entry (e.g., acitretin, isotretinoin).
- Use of laser or light based rosacea treatments within the past 2 months.
- History of hypersensitivity or allergies to any ingredient in the study drug.
- Current drug or alcohol abuse.
- Have participated in any clinical trial involving an investigational drug or cosmetic product or procedure within the past 30 days.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00945373
Start Date
July 1 2009
End Date
October 1 2010
Last Update
June 17 2019
Active Locations (1)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029