Erythematotelangiectatic RosaceaPhase 1NCT00945373
Combination Therapy for the Treatment of Rosacea
A Phase 1 study testing calcium dobesilate and pulsed dye laser in people with Erythematotelangiectatic Rosacea, run by Ellen Marmur at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erythematotelangiectatic Rosacea
- What is being tested?
- calcium dobesilate and pulsed dye laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Oct 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: Combination Therapy for the Treatment of Erythematotelangiectatic Rosacea
The purpose of this study is to determine the efficacy of calcium dobesilate in combination with pulsed dye laser for the treatment of rosacea.
Read the 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.
- Conditions
- Erythematotelangiectatic Rosacea
- Being tested
- calcium dobesilate, pulsed dye laser
- Keywords
- rosacea, telangiectasias, topical treatment, pulsed dye laser
- Medical subject headings
- Rosacea, Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium dobesilateDrug
2.5% gel
pulsed dye laserProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Erythematotelangiectatic Rosacea | Experimental | 2.5% gel calcium dobesilate and pulsed dye laser Receives: Drug: calcium dobesilate; Procedure: pulsed dye laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythematotelangiectatic RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ellen Marmur
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Laser Surgery and Medicine
- Responsible party
- Sponsor-investigator, Ellen Marmur, Icahn School of Medicine at Mount Sinai
- Investigators
- Ellen Marmur, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945373
- Sponsor's protocol ID
- GCO # 09-0839
- Status last verified
- Jun 2019
- First submitted
- 23 Jul 2009
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy for the Treatment of Erythematotelangiectatic Rosacea
- ClinicalTrials.gov ID
- NCT00945373
- Acronym / sponsor ID
- GCO # 09-0839
- Conditions
- Erythematotelangiectatic Rosacea
- Keywords
- rosacea, telangiectasias, topical treatment, pulsed dye laser
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Ellen MarmurUniversity, hospital or other
- Collaborators
- American Society for Laser Surgery and Medicine
- Study start
- Jul 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erythematotelangiectatic Rosacea | Experimental | Drug: calcium dobesilate, Procedure: pulsed dye laser2.5% gel calcium dobesilate and pulsed dye laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calcium dobesilate2.5% gel | Drug | Erythematotelangiectatic Rosacea |
| pulsed dye laserAll 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. | Procedure or surgery | Erythematotelangiectatic Rosacea |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Marmur, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing calcium dobesilate and pulsed dye laser in people with Erythematotelangiectatic Rosacea, run by Ellen Marmur at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator Global Assessment (IGA) scale (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019; AzTrials last refreshed its copy on 7 Nov 2026.