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TelangiectasiasPhase 4NCT02761174

Topical Brimonidine to Reduce Inflammation After IPL-treatment in Patients With Facial Telangiectasias

A Phase 4 study testing Brimonidine and IPL+air-cooling in people with Telangiectasias, run by Merete Haedersdal at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Telangiectasias
What is being tested?
Brimonidine and IPL+air-cooling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteDenmark
Study dates
13 Mar 2016to 13 Jan 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Bispebjerg Hospital

    Copenhagen NV, 2200

Other trials in Denmark

About this study

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.

Read the detailed description

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.

Conditions
Telangiectasias
Being tested
Brimonidine, IPL+air-cooling
Keywords
Vascular lesions, inflammation, IPL
Medical subject headings
Telangiectasis, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrimonidineDrug

    Also called Mirvaso cream

    Patients receive brimonidine to half of their face, whereas the other half receives no treatment and thereby patients are their own control

  • IPL+air-coolingOther

    IPL+air-cooling are applied to the whole face and the control side thereby only receives IPL+air-cooling

Study groups in NCT02761174
Study groupRoleWhat they receive
Brimonidine (Mirvaso cream)Active comparatorThis 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.
Receives: Drug: Brimonidine
IPL+air-coolingOtherThis 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).
Receives: Other: IPL+air-cooling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Throughout the study, a period of 10 weeks

  2. 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.

    Measured: Throughout the study, a period of 10 weeks

Secondary outcomes (3)

  1. 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.

    Measured: At the end of the study (after 10 weeks)

  2. 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

    Measured: Throughout the study, a period of 10 weeks

  3. 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.

    Measured: Throughout the study, a period of 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2016 (estimated)
  2. Study start13 Mar 2016
  3. Primary completion11 Jul 2016
  4. Study completion13 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02761174
Sponsor's protocol ID
2015-004789-27
Other IDs
2015
Status last verified
Jan 2018
First submitted
17 Mar 2016
Last updated
5 Jan 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
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

Publications

  • Tierney E, Hanke CW. Randomized controlled trial: Comparative efficacy for the treatment of facial telangiectasias with 532 nm versus 940 nm diode laser. Lasers Surg Med. 2009 Oct;41(8):555-62. doi: 10.1002/lsm.20811.

    PubMed 19746429

  • Adamic M, Pavlovic MD, Troilius Rubin A, Palmetun-Ekback M, Boixeda P. Guidelines of care for vascular lasers and intense pulse light sources from the European Society for Laser Dermatology. J Eur Acad Dermatol Venereol. 2015 Sep;29(9):1661-78. doi: 10.1111/jdv.13177. Epub 2015 Apr 30.

    PubMed 25931003

  • Taub AF, Devita EC. Successful treatment of erythematotelangiectatic rosacea with pulsed light and radiofrequency. J Clin Aesthet Dermatol. 2008 May;1(1):37-40.

    PubMed 21103309

  • Tanghetti EA. Split-face randomized treatment of facial telangiectasia comparing pulsed dye laser and an intense pulsed light handpiece. Lasers Surg Med. 2012 Feb;44(2):97-102. doi: 10.1002/lsm.21151. Epub 2011 Dec 16.

    PubMed 22180317

  • Nymann P, Hedelund L, Haedersdal M. Long-pulsed dye laser vs. intense pulsed light for the treatment of facial telangiectasias: a randomized controlled trial. J Eur Acad Dermatol Venereol. 2010 Feb;24(2):143-6. doi: 10.1111/j.1468-3083.2009.03357.x.

    PubMed 20205349

  • Uebelhoer NS, Bogle MA, Stewart B, Arndt KA, Dover JS. A split-face comparison study of pulsed 532-nm KTP laser and 595-nm pulsed dye laser in the treatment of facial telangiectasias and diffuse telangiectatic facial erythema. Dermatol Surg. 2007 Apr;33(4):441-8. doi: 10.1111/j.1524-4725.2007.33091.x.

    PubMed 17430378

  • Papageorgiou P, Clayton W, Norwood S, Chopra S, Rustin M. Treatment of rosacea with intense pulsed light: significant improvement and long-lasting results. Br J Dermatol. 2008 Sep;159(3):628-32. doi: 10.1111/j.1365-2133.2008.08702.x. Epub 2008 Jun 28.

    PubMed 18565174

  • Clark C, Cameron H, Moseley H, Ferguson J, Ibbotson SH. Treatment of superficial cutaneous vascular lesions: experience with the KTP 532 nm laser. Lasers Med Sci. 2004;19(1):1-5. doi: 10.1007/s10103-004-0294-x. Epub 2004 Apr 14.

    PubMed 15316851

  • Eremia S, Li CY. Treatment of face veins with a cryogen spray variable pulse width 1064 nm Nd:YAG Laser: a prospective study of 17 patients. Dermatol Surg. 2002 Mar;28(3):244-7. doi: 10.1046/j.1524-4725.2002.01217.x.

    PubMed 11896777

  • Bjerring P, Christiansen K, Troilius A. Intense pulsed light source for treatment of facial telangiectasias. J Cosmet Laser Ther. 2001 Dec;3(4):169-73. doi: 10.1080/14764170160260744.

    PubMed 12554324

  • Mark KA, Sparacio RM, Voigt A, Marenus K, Sarnoff DS. Objective and quantitative improvement of rosacea-associated erythema after intense pulsed light treatment. Dermatol Surg. 2003 Jun;29(6):600-4. doi: 10.1046/j.1524-4725.2003.29141.x.

    PubMed 12786702

  • Anderson RR, Parrish JA. Selective photothermolysis: precise microsurgery by selective absorption of pulsed radiation. Science. 1983 Apr 29;220(4596):524-7. doi: 10.1126/science.6836297.

    PubMed 6836297

  • Srinivas CR, Kumaresan M. Lasers for vascular lesions: standard guidelines of care. Indian J Dermatol Venereol Leprol. 2011 May-Jun;77(3):349-68. doi: 10.4103/0378-6323.79728.

    PubMed 21508585

  • Handley JM. Adverse events associated with nonablative cutaneous visible and infrared laser treatment. J Am Acad Dermatol. 2006 Sep;55(3):482-9. doi: 10.1016/j.jaad.2006.03.029.

    PubMed 16908355

  • Alam M, Omura NE, Dover JS, Arndt KA. Clinically significant facial edema after extensive treatment with purpura-free pulsed-dye laser. Dermatol Surg. 2003 Sep;29(9):920-4. doi: 10.1046/j.1524-4725.2003.29254.x.

    PubMed 12930333

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Brimonidine and IPL+air-cooling in people with Telangiectasias, run by Merete Haedersdal at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02761174, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2018.

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