A Phase 4 interventional study of Brimonidine and IPL+air-cooling in Telangiectasias, sponsored by Merete Haedersdal. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-01-05.
Sponsored by Merete Haedersdal · Phase 4, Interventional, and Treatment
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.
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:
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.
Other excipients:
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.
153 studies on the registry are indexed under Telangiectasis; 16 are open to participants now.
This study's enrollment of 19 is below the median of 30 across 107 interventional studies indexed under Telangiectasis.
Browse Telangiectasis studies →Merete Haedersdal is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
During the study, fertile women must be using effective birth control. Effective contraception is defined as follows:
Exclusion Criteria:
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
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
Patients receive brimonidine to half of their face, whereas the other half receives no treatment and thereby patients are their own control
Also known as: 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.
Erythema is evaluated on the international validated, "Clinician's Erythema Assessment" (CEA) 5-point scale: 0, Clear Clear skin with no signs of erythema 1. Almost clear Almost clear; slight redness 2. Mild Mild erythema; definite redness 3. Moderate Moderate erythema; marked redness 4. Severe Severe erythema; fiery redness
Time frame: Throughout the study, a period of 10 weeks
Reduction in oedema quantified by blinded clinical on-site evaluation and by blinded photo-evaluation.
Oedema is evaluated on a 4-point scale: 0 = no oedema, 1 = little oedema, 2 = moderate oedema and 3 = severe oedema.
Time frame: Throughout the study, a period of 10 weeks
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.
Baseline photos are compared to photos at final follow-up visit approximate 10 weeks after.
Time frame: At the end of the study (after 10 weeks)
Patient discomfort and pain
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
Time frame: Throughout the study, a period of 10 weeks
Patient overall satisfaction
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.
Time frame: Throughout the study, a period of 10 weeks
Plan to share: Yes — 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
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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