Combination Therapy for the Treatment of Rosacea

• ClinicalTrials.gov Identifier: NCT00945373
• Recruitment Status: Completed
• First Posted: July 24, 2009
• Last Update Posted: June 17, 2019
• Sponsor: Ellen Marmur
• Collaborator: American Society for Laser Surgery and Medicine
• Information provided by (Responsible Party): Ellen Marmur, Icahn School of Medicine at Mount Sinai

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Erythematotelangiectatic Rosacea	Drug: calcium dobesilate; Procedure: pulsed dye laser	Phase 1

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 the face such as the cheeks, chin, nose and central aspects of the forehead.

The flushing and telangiectasias associated with erythematotelangietatic rosacea (ETR) are notoriously difficult to treat with standard medications. Patients with ETR have a lower threshold for irritation from topically applied drugs and these substances may even exacerbate their symptoms.

Pulsed dye laser (PDL) is widely considered as the treatment of choice for vascular malformations including telangiectasias, port wine stains and hemangiomas. Several studies have shown successful treatment of rosacea-associated telangiectasia and erythema with pulsed dye laser. Moreover, calcium dobesilate (2,5-dihydroxybenzene sulfonate) is a drug that inhibits vascular smooth muscle cell growth and inhibits cellular proliferation. As a synthetic inhibitor of fibroblast growth factor (FGF), calcium dobesilate targets angiogenic growth factors which lead to uncontrolled blood vessel growth. In light of the fact that angiogenesis has been implicated in erythematotelangietatic rosacea, calcium dobesilate will be useful in the treatment of this subtype of rosacea.

Thus, combination treatment with PDL and calcium dobsilate will act in a synergistic manner to reduce the erythema, flushing and telangectasia associated with erythematotelangietatic rosacea.

If the subject meets the inclusion criteria and informed consent is obtained, the subject will receive 2.5% calcium dobesilate get to apply to half of the face (randomized). The subject will also receive pulsed dye laser treatments to the whole face at two week intervals for a maximum of 3 treatments. The primary endpoint of this study will be the severity of rosacea at the end of the 20 week study.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Combination Therapy for the Treatment of Erythematotelangiectatic Rosacea
• Study Start Date: July 2009
• Actual Primary Completion Date: May 2010
• Actual Study Completion Date: October 2010

Arms and Interventions

Arm

Intervention/treatment

Experimental: Erythematotelangiectatic Rosacea; 2.5% gel calcium dobesilate and pulsed dye laser

Drug: calcium dobesilate; 2.5% gel; Procedure: pulsed dye laser; 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.

Outcome Measures

Primary Outcome Measures :

1. Investigator Global Assessment (IGA) scale [ Time Frame: one year ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, New York

Mount Sinai School of Medicine

New York, New York, United States, 10029

Sponsors and Collaborators

Ellen Marmur

American Society for Laser Surgery and Medicine

Investigators

• Principal Investigator: Ellen Marmur, MD; Icahn School of Medicine at Mount Sinai

More Information

• Responsible Party: Ellen Marmur, Principal Investigator, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT00945373
• Other Study ID Numbers: GCO # 09-0839
• First Posted: July 24, 2009
• Last Update Posted: June 17, 2019
• Last Verified: June 2019

Keywords provided by Ellen Marmur, Icahn School of Medicine at Mount Sinai:

rosacea; telangiectasias; topical treatment; pulsed dye laser

Additional relevant MeSH terms:

Rosacea; Skin Diseases; Calcium Dobesilate; Calcium; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Hemostatics; Coagulants