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|
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Study design The study is designed as a dual-centre, randomized, intra-individual, split-face clinical controlled trial with blinded outcome assessment. A total of 20 patients with moderate to severe facial telangiectasias, without other clinical active dermatological disease in the skin, will be included. Severity and distribution (cheek, nose and chin) of telangiectasias must be symmetrical between facial sides in the individual patient at inclusion. All patients will receive IPL-treatments to both sides of the face. Before the first IPL-treatment, the left and right side of the face will be randomized to either brimonidine (Mirvaso) or only IPL-treatment and air-cooling (control), respectively. The study is conducted in an international collaboration between Bispebjerg Hospital, Department of Dermatology in Denmark and "Skinperium" private practice in Belgium.
Interventions Patients are asked to attend 3 treatment days and 2 follow-up visits. Treatment days are planed with 3 weeks intervals (± 5 days) and follow-up visits are planned at trial day 2 (one day after treatment day 1) and at 1 month (± 5 days) after the final treatment day. The consultations are estimated to last between half an hour and two hours. Patients are further asked to fill out patient diaries in the first 6 days after follow-up visit at trial day 2.
At each treatment day, patients receive 1) IPL of their whole face, 2) brimonidine is thereafter applied to the facial side randomized to treatment followed by 3) air-cooling, which is applied to the whole face of the patient in accordance with clinical guidelines.
Efficacy endpoints & evaluation methods
Primary efficacy endpoint:
To investigate whether topical brimonidine can reduce IPL-induced inflammatory response
Secondary efficacy endpoints:
- IPL-induced treatment efficacy on telangiectasias with and without application of brimonidine
- Patient-evaluated subjective discomfort and pain in the treatment area
- Overall patient satisfaction
Primary efficacy endpoint is quantified by reduction in erythema and oedema assessed by blinded clinical on-site evaluation and by blinded photo-evaluation.
Secondary efficacy endpoints regarding point 1 are quantified by blinded photo-evaluation obtained with a Visia camera, in which baseline-photos are compared to photos from the final follow-up visit. Point 2 and 3 are evaluated on two separate 0-10 point Visual Analogue Scales (VAS) on discomfort/pain and patient satisfaction, respectively. Patient satisfaction is further evaluated in patient diaries.
Product Mirvaso® (brimonidine tartrate (3,3mg/1g), Galderma Nordic) One gram of gel contains 3.3 mg of brimonidine, equivalent to 5 mg of brimonidine tartrate.
Excipient(s) with known effect:
One gram of gel contains 1 mg methylparahydroxybenzoate (E218) and 55 mg propylene glycol.
- Carbomer Methylparahydroxybenzoate (E218) Phenoxyethanol
- Titanium dioxide
- Propylene glycol
- Sodium hydroxide
- Purified water
Statistic analysis Primary efficacy endpoint is difference in inflammation between brimonidine vs. control.
Wilcoxon signed-rank test will be used for paired comparison to evaluate eventual differences between brimonidine vs. control. Analysis on Per-Protocol will only include the patients completing the study according to protocol.
Sample size Estimation of sample size is based on clinical on-site evaluation on inflammation 30 minutes after incubation of brimonidine (effect of brimonidine is evident after 30 minutes cf.´Summary of Product Characteristics) and 24 hours after application.
With a power of 90%, a type I error probability of 5% and an estimated standard deviation of 25%, we should include 17 patients to detect a minimum relevant difference (MIREDIF) of 20% between brimonidine and control. We choose a 20% MIREDIF, since a reduction in inflammation <20%, based on a resource economic point of view is considered clinical irrelevant. Based on earlier experience and duration of the trial, a 15% dropout rate should be taken into account and therefore, a total of 20 patients will be included.
|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|