Combination Therapy for the Treatment of Rosacea

NCT00945373 | Completed Phase 1

• 1 other identifier: GCO # 09-0839
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Erythematotelangiectatic Rosacea

Keywords

rosacea; telangiectasias; topical treatment; pulsed dye laser

Outcome Measures

Primary Outcomes (1)

• Investigator Global Assessment (IGA) scale

  Global rosacea scale assssed as the success of rosacea treatment is usually defined as a score of 1 ('almost clear') or 0 ('clear') on the 5-point Investigator Global Assessment (IGA) scale. full scale from 0-4, with higher score indicating more disease.

  one year

Study Arms (1)

Erythematotelangiectatic Rosacea

EXPERIMENTAL

2.5% gel calcium dobesilate and pulsed dye laser

Drug: calcium dobesilate; Procedure: pulsed dye laser

Interventions

calcium dobesilate DRUG

2.5% gel

Erythematotelangiectatic Rosacea

pulsed dye laser PROCEDURE

All study patients will be treated with 595 nm PDL (Vbeam, Candela Corp, Wayland, Mass) with an initial test spot using a fluence of 10 J/cm2, 7-mm spot size and 1.5-ms pulse duration. Based on the biologic response of the test area, the fluence will accordingly be adjusted up or down to find a fluence that produces a transient purpuric effect for a few seconds only.

Erythematotelangiectatic Rosacea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ellen Marmur: lead
• American Society for Laser Surgery and Medicine: collaborator

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Rosacea; Telangiectasis

Interventions

Calcium Dobesilate; Lasers, Dye

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Ellen Marmur, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2009
• First Posted: July 24, 2009
• Study Start: July 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 17, 2019

Record last verified: 2019-06

Locations

US (1)