Topical Brimonidine to Reduce Inflammation After IPL-treatment in Patients With Facial Telangiectasias
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|ClinicalTrials.gov Identifier: NCT02761174|
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : January 5, 2018
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
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
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).
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.
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
|Copenhagen NV, Denmark, 2200|
|Principal Investigator:||Merete Hædersdal, Prof., MD||Department of Dermatology|