Telangiectasias Clinical Trial
Official title:
Topical Brimonidine Reduces IPL-induced Erythema Without Affecting Efficacy: a Randomized Controlled Trial in Patients With Facial Telangiectasias
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:
1. IPL-induced treatment efficacy on telangiectasias with and without application of
brimonidine
2. Patient-evaluated subjective discomfort and pain in the treatment area
3. 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.
Other excipients:
- Carbomer Methylparahydroxybenzoate (E218) Phenoxyethanol
- Glycerol
- 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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT01118390 -
Treatment of Leg Telangiectasias With Nd:YAG 1064nm
|
N/A |