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Combination Therapy for the Treatment of Rosacea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00945373
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : June 22, 2011
Sponsor:
Collaborator:
American Society for Laser Surgery and Medicine
Information provided by:
Marmur, Ellen, M.D.

Tracking Information
First Submitted Date  ICMJE July 23, 2009
First Posted Date  ICMJE July 24, 2009
Last Update Posted Date June 22, 2011
Study Start Date  ICMJE July 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2009)
global rosacea scale [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00945373 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Therapy for the Treatment of Rosacea
Official Title  ICMJE Combination Therapy for the Treatment of Erythematotelangiectatic Rosacea
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 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 Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Erythematotelangiectatic Rosacea
Intervention  ICMJE
  • 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.
Study Arms Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2011)
6
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2009)
10
Actual Study Completion Date October 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00945373
Other Study ID Numbers  ICMJE GCO # 09-0839
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ellen Marmur, Chief, Dermatologic & Cosmetic Surgery, Mount Sinai School of Medicine
Study Sponsor  ICMJE Marmur, Ellen, M.D.
Collaborators  ICMJE American Society for Laser Surgery and Medicine
Investigators  ICMJE
Principal Investigator: Ellen Marmur, MD Icahn School of Medicine at Mount Sinai
PRS Account Marmur, Ellen, M.D.
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP