Combination Therapy for the Treatment of Rosacea

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ellen Marmur; Marmur, Ellen, M.D.
• Collaborator: American Society for Laser Surgery and Medicine
• Treatments: Calcium; Calcium Dobesilate

Criteria

Inclusion Criteria:

1. Must understand and voluntarily sign an informed consent form.

2. Must be male or female and aged ≥ 18 years at time of consent.

3. Must be able to adhere to the study visit schedule and other protocol requirements.

4. Must have clinically typical confirmed diagnosis of erythematotelangestatic rosacea.

5. 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.

6. 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 Criteria:

1. Inability to provide voluntary informed consent.

2. Pregnant or breastfeeding female.

3. 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.

4. Current or past ocular rosacea, such as conjunctivitis, iritis and keratitis of sufficient severity to require topical or systemic antibiotics.

5. Subjects with recurrent gastritis, renal dysfunction or ulcer disease (peptic or duodenal).

6. 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.

7. Treatment with any systemic medication or therapy known to affect inflammatory responses within the 30 days prior to baseline and throughout the study.

8. Treatment with systemic retinoids within 6 months prior to study entry (e.g., acitretin, isotretinoin).

9. Use of laser or light based rosacea treatments within the past 2 months.

10. History of hypersensitivity or allergies to any ingredient in the study drug.

11. Current drug or alcohol abuse.

12. Have participated in any clinical trial involving an investigational drug or cosmetic product or procedure within the past 30 days.