Topical Brimonidine to Reduce Inflammation After IPL-treatment in Patients With Facial Telangiectasias
![]() |
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: NCT02761174 |
Recruitment Status :
Completed
First Posted : May 4, 2016
Last Update Posted : January 5, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
The aim of the study is to investigate whether brimonidine cream can reduce IPL-induced inflammation in terms of redness, swelling and pain in patients with facial vascular lesions (telangiectasias). Furthermore, the effect of brimonidine cream on IPL-efficacy is evaluated one month after final IPL-treatment.
The hypothesis is that brimonidine, which has been proved effective in reduction of symptomatic erythema in patients with rosacea, also may have the ability to reduce IPL-induced erythema. Since the potential reduction in erythema is caused by vasoconstriction, brimonidine may further reduce IPL-induced oedema and pain.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Telangiectasias | Drug: Brimonidine Other: IPL+air-cooling | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Topical Brimonidine Reduces IPL-induced Erythema Without Affecting Efficacy: a Randomized Controlled Trial in Patients With Facial Telangiectasias |
Actual Study Start Date : | March 13, 2016 |
Actual Primary Completion Date : | July 11, 2016 |
Actual Study Completion Date : | January 13, 2017 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Brimonidine (Mirvaso cream)
This is a split-face study, and patients are thereby their own control. Patients receive IPL-treatment and air-cooling to the whole face (control) and 0.5 g of brimonidine (Mirvaso cream) to the randomized side of the face.
|
Drug: Brimonidine
Patients receive brimonidine to half of their face, whereas the other half receives no treatment and thereby patients are their own control
Other Name: Mirvaso cream |
IPL+air-cooling
This is a split-face study, and patients are thereby their own control. Patients receive IPL-treatment and air-cooling to the whole face and IPL+air-cooling (control) are thereby compared to IPL+air-cooling+brimonidine (Mirvaso cream).
|
Other: IPL+air-cooling
IPL+air-cooling are applied to the whole face and the control side thereby only receives IPL+air-cooling |
- Reduction in erythema quantified by blinded clinical on-site evaluation and by blinded photo-evaluation. [ Time Frame: Throughout the study, a period of 10 weeks ]
Erythema is evaluated on the international validated, "Clinician's Erythema Assessment" (CEA) 5-point scale:
0, Clear Clear skin with no signs of erythema
- Almost clear Almost clear; slight redness
- Mild Mild erythema; definite redness
- Moderate Moderate erythema; marked redness
- Severe Severe erythema; fiery redness
- Reduction in oedema quantified by blinded clinical on-site evaluation and by blinded photo-evaluation. [ Time Frame: Throughout the study, a period of 10 weeks ]Oedema is evaluated on a 4-point scale: 0 = no oedema, 1 = little oedema, 2 = moderate oedema and 3 = severe oedema.
- The effect of brimonidine on IPL-efficacy quantified by blinded photo-evaluation obtained with a Visia camera, in which baseline-photos are compared to photos from the final follow-up visit. [ Time Frame: At the end of the study (after 10 weeks) ]Baseline photos are compared to photos at final follow-up visit approximate 10 weeks after.
- Patient discomfort and pain [ Time Frame: Throughout the study, a period of 10 weeks ]Patient discomfort and pain are evaluated on a numeric Visual Analogue Scale (VAS) from 0 (no discomfort/pain) to 10 (extreme discomfort/pain) separately for brimonidine and control
- Patient overall satisfaction [ Time Frame: Throughout the study, a period of 10 weeks ]Patients evaluate their overall satisfaction with brimonidine to reduce IPL-induced inflammation on a numeric VAS from 0 (poor outcome) to 10 (excellent outcome). Inflammation is described as redness, swelling and pain to the patient.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with moderate to severe facial telangiectasias referred to laser or IPL-treatment. Severity and distribution of telangiectasias must be symmetrical between left and right side of the face in the individual patient
- Telangiectasias may be observed in connection with rosacea, but rosacea must not demonstrate clinical active inflammation or acne
- 18-65 years of age
- Fitzpatrick skin type I-III
- Fertile women must document non-reactive urine pregnancy test at the day of inclusion
-
During the study, fertile women must be using effective birth control. Effective contraception is defined as follows:
- Injectable, implantable or orally taken hormones;
- Intrauterine device;
- Trans-abdominal surgical sterilization;
- Sterilization implant device;
- Surgical sterilization of male partner;
- Complete abstinence from sexual intercourse for two weeks before exposure to study medication and throughout the clinical study
- Verbal and written consent to participate in the study
- Documentation of medicine status
Exclusion Criteria:
- Clinical active dermatological disease in the face
- Wounds, dermatitis, tattoos or scars in treatment area
- Allergies to ingredients in Mirvaso
- Current treatment with monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants which interacts with the noradrenergic transmission
- Current treatment with other systemic adrenergic receptor agonists or antagonists
- Patients with known liver or renal disease
- UV-exposure (solarium or sunbathing) or other treatment within the last month that enhances skin pigmentation
- Use of other topical agents that may interact with treatment
- Local or systemic treatment with photosensitizing drugs
- Pregnancy and breastfeeding women
- Current participation in other clinical trials
- Patients that are considered incapable of complying with the protocol, i.e. patients suffering from dementia, alcoholism or psychiatric conditions

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): NCT02761174
Denmark | |
Bispebjerg Hospital | |
Copenhagen NV, Denmark, 2200 |
Principal Investigator: | Merete Hædersdal, Prof., MD | Department of Dermatology |
Additional Information:
Publications:
Responsible Party: | Merete Haedersdal, Professor, MD, DMSc, PhD, Bispebjerg Hospital |
ClinicalTrials.gov Identifier: | NCT02761174 History of Changes |
Other Study ID Numbers: |
2015-004789-27 |
First Posted: | May 4, 2016 Key Record Dates |
Last Update Posted: | January 5, 2018 |
Last Verified: | January 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Sponsor and investigator allow access to registries, CRF and trial master files in case of audit or quality inspection from relevant authorities such as GCP-unit, Danish Health and Medicine Authority or The Regional Committee on Health Research Ethics |
Vascular lesions inflammation IPL |
Telangiectasis Vascular Diseases Cardiovascular Diseases Brimonidine Tartrate Antihypertensive Agents Adrenergic alpha-2 Receptor Agonists |
Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |