Combination Therapy for the Treatment of Rosacea
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|ClinicalTrials.gov Identifier: NCT00945373|
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : June 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Erythematotelangiectatic Rosacea||Drug: calcium dobesilate Procedure: pulsed dye laser||Phase 1|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Erythematotelangiectatic Rosacea
2.5% gel calcium dobesilate and pulsed dye laser
Drug: calcium dobesilate
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945373
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Ellen Marmur, MD||Icahn School of Medicine at Mount Sinai|