Edema FacePhase 2/3NCT03715387
Tacrolimus for Malar Edema
A Phase 2/3 study testing Tacrolimus Topical 0.1% Topical Ointment and Polysporin Ointment in people with Edema Face, run by University of British Columbia at 1 site in Canada.
Trial summary
Elective lower eyelid surgery is a common cosmetic procedure. Facial swelling is a common complication. Studies suggest that this facial swelling is part of a complex inflammatory process. Topical tacrolimus has long been used to treat various inflammatory skin disorders. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edema Face
- What is being tested?
- Tacrolimus Topical 0.1% Topical Ointment and Polysporin Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 10 Oct 2018to 1 Jul 2019
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bilateral lower lid blepharoplasty, facelift, or both.
- Patients over 18 years of age.
Who cannot join
- -Patients presenting for revision surgery.
- Patients with a known allergy to tacrolimus.
- Patients taking medications that alter tacrolimus metabolism:
- Anticonvulsants: carbamazepine, phenobarbital, phenytoin
- Antibiotics: rifampicin, rifabutin
- Antifungal: clotrimazole, ketoconazole, fluconazole, itraconazole
Show all 13Show fewer
- Ca++ channel blockers: diltiazem, nifedipine, nicardipine, verapamil
- Macrolides: erythromycin, clarithromycin, troleandomycin
- Miscellaneous: cyclosporin A, danazol, bromocriptine, cimetidine, methylprednisolone, protease inhibitors
- Patients with previously diagnosed reduced kidney function.
- Immunocompromised patients.
- Patients with a history of cutaneous facial malignancies.
- Patients with active cutaneous facial infections.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Vancouver Plastic Surgery Center
Vancouver, British Columbia, V5Z 4J7
Richard Warren, MD, 604-876-1774
Tracy Stuby
About this study
Official title: Malar Bags After Lower Lid Blepharoplasty and Facelift: A Randomized Controlled Trial of the Effects of Tacrolimus
Elective lower eyelid surgery is a common cosmetic procedure. Facial swelling is a common complication. Studies suggest that this facial swelling is part of a complex inflammatory process. Topical tacrolimus has long been used to treat various inflammatory skin disorders. By combining our knowledge of facial swelling and tacrolimus mechanism of action, we can hypothesize that it can be used as a treatment to prevent this post-operative swelling. The purpose of this project is to apply topical tacrolimus to one of the patient's cheeks following facial surgery and compare the incidence of facial swelling to the opposite side control cheek.
Read the detailed description
1.0 Purpose:
To perform a randomized controlled trial to determine if topical tacrolimus ointment reduces incidence or severity of post-operative facial edema and malar bags after elective blepharoplasty and/or facelift.
2.0 Hypothesis:
Topical tacrolimus will reduce the incidence and severity of post-operative facial edema presenting as malar bags after blepharoplasty and/or facelift.
3.0 Justification:
Elective blepharoplasty is the fourth most common cosmetic procedures performed in North America. According to a report published by the American Society of Plastic Surgery, eye lid surgery accounted for 209,000 out of the 1.7 million cosmetic surgical procedures performed in 2016. Additionally, the number of eye lid surgeries rose 2% in 2016 compared to 2015 [ref 1].
Recurrent or worsened malar bags is a common complication of lower lid surgery. Studies suggest that post-operative lymphedema is a possible cause of these malar bags. Recent research into lymphedema pathophysiology shows that post-operative lymphedema is not simply a result of direct lymphatic injury, but rather a complex fibroproliferative inflammatory process.
Topical tacrolimus has long been used to treat various inflammatory skin disorders such as atopic dermatitis and psoriasis safely and effectively. By combining our knowledge of lymphedema pathophysiology and tacrolimus mechanism of action, we can hypothesize that it can be effectively used as a treatment to prevent post-operative malar bags as a result of lymphedema.
4.0 Objectives:
4.1. To apply topical tacrolimus ointment to a randomized cheek in sequential patients undergoing lower lid blepharoplasty, facelift or both and compare to the contralateral control cheek.
4.2. To determine if topical tacrolimus affects the incidence and severity of post-operative malar edema compared to the self-matched contralateral control cheek.
5.0 Research Design:
This is a double blinded randomized controlled trial involving an initial surgery followed by random topical drug treatment that is self matched to a contralateral control side. There will be 3 follow up visits for analysis.
6.0 Statistical Analysis:
6.1 Statistical Considerations
The primary endpoint is post operative malar edema which typically occurs 10-20% of the time following lower lid blepharoplasty and/or facelift procedures. If we expect to reduce the occurrence to 1-5% the number of patients required to achieve a significant result (α = 0.05 (2-sided), β = 0.20) is 40-100.
No increase in sample size has been made to account for losses to follow-up. In our practice over the past 10 years we have found that less than 1% of patients do not return for a follow-up visit.
6.2 Outcome Measures
A custom four point scale will be used to record the outcomes for each cheek:
I: No post operative edema. II: Mild post operative edema. III: Moderate post operative edema. IV: Severe post operative edema.
Example photographs will be provided to the blinded rater for each category.
6.3 Data Collection
Outcome measurements will be performed by a single observer who will be blinded to the contents of the containers and which cheek either was applied to. Data will be collected on study specific data collection forms.
7.0 Procedure
7.1 Surgical Procedure
The lower lid blepharoplasty and facelift procedures will be performed by Dr. Richard Warren in the usual fashion based on the patient's presenting problem. Specific differences in technique such as skin only excision vs fat transposition and ORL (Orbicularis Retaining Legament) division will be recorded and analyzed separately.
7.2 Tacrolimus Application
Patients will be given two containers labelled with "Right" and "Left" to be applied to their right and left cheeks respectively. The patients will apply the ointment once daily for 4 weeks post operatively. The contents of the containers will be randomized to either the treatment tacrolimus ointment or the control ointment which will be matched in colour and consistency to the tacrolimus ointment. They will be given instructions on applying the ointments based on FDA recommendations.
7.3 Choice of Tacrolimus Dose
The treatment containers will contain 0.1% tacrolimus ointment (marketed as PROTOPIC) based on FDA recommendations for adult patients. This dose of the drug is known to be sufficiently absorbed by inflamed skin reaching peak concentrations of 0.05-0.25ng/ml 3-6 hours after application. This is significantly lower than the accepted safe level of 5-20ng/ml established based on transplant research. [ref 16,17]
7.4 Post-operative Treatment
Patients will be followed post operatively in the office at 1 week, 4 weeks, and 6 months. Degree of post operative malar edema will be assessed by a single blinded observer. This will be recorded using a four point scale. Any side effects or adverse events will also be recorded.
- Conditions
- Edema Face
- Being tested
- Tacrolimus Topical 0.1% Topical Ointment, Polysporin Ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus Topical 0.1% Topical OintmentDrug
Also called Protopic
Topical tacrolimus ointment
Polysporin OintmentDrug
Also called Polysporin
Polysporin ointment
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus Treatment | Experimental | Tacrolimus Topical 0.1% Topical Ointment Receives: Drug: Tacrolimus Topical 0.1% Topical Ointment |
| Control | Placebo comparator | Patients will be self matched controls with one cheek receiving the study ointment and the other receiving a control ointment (polysporin ointment). Receives: Drug: Polysporin Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malar edema
Development of malar edema post operatively
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start10 Oct 2018
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Edema FaceStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Patients will serve as their own self matched controls with one study cheek and one control cheek.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Warren, University of British Columbia
- Investigators
- Richard Warren, MD, Principal investigator, University of British ColumbiaStahs Pripotnev, MD, Study chair, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715387
- Sponsor's protocol ID
- H17-02969
- Status last verified
- Oct 2018
- First submitted
- 19 Oct 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pessa JE, Garza JR. The malar septum: the anatomic basis of malar mounds and malar edema. Aesthet Surg J. 1997 Jan-Feb;17(1):11-7. doi: 10.1016/s1090-820x(97)70001-3.
PubMed 19327681Nagi KS, Carlson JA, Wladis EJ. Histologic assessment of dermatochalasis: elastolysis and lymphostasis are fundamental and interrelated findings. Ophthalmology. 2011 Jun;118(6):1205-10. doi: 10.1016/j.ophtha.2010.10.013. Epub 2011 Jan 6.
PubMed 21211847Nijhawan N, Marriott C, Harvey JT. Lymphatic drainage patterns of the human eyelid: assessed by lymphoscintigraphy. Ophthalmic Plast Reconstr Surg. 2010 Jul-Aug;26(4):281-5. doi: 10.1097/IOP.0b013e3181c32e57.
PubMed 20551850Kpodzo DS, Nahai F, McCord CD. Malar mounds and festoons: review of current management. Aesthet Surg J. 2014 Feb;34(2):235-48. doi: 10.1177/1090820X13517897. Epub 2014 Jan 15.
PubMed 24431347Cemal Y, Pusic A, Mehrara BJ. Preventative measures for lymphedema: separating fact from fiction. J Am Coll Surg. 2011 Oct;213(4):543-51. doi: 10.1016/j.jamcollsurg.2011.07.001. Epub 2011 Jul 28. No abstract available.
PubMed 21802319Ghanta S, Cuzzone DA, Torrisi JS, Albano NJ, Joseph WJ, Savetsky IL, Gardenier JC, Chang D, Zampell JC, Mehrara BJ. Regulation of inflammation and fibrosis by macrophages in lymphedema. Am J Physiol Heart Circ Physiol. 2015 May 1;308(9):H1065-77. doi: 10.1152/ajpheart.00598.2014. Epub 2015 Feb 27.
PubMed 25724493Avraham T, Zampell JC, Yan A, Elhadad S, Weitman ES, Rockson SG, Bromberg J, Mehrara BJ. Th2 differentiation is necessary for soft tissue fibrosis and lymphatic dysfunction resulting from lymphedema. FASEB J. 2013 Mar;27(3):1114-26. doi: 10.1096/fj.12-222695. Epub 2012 Nov 27.
PubMed 23193171Clavin NW, Avraham T, Fernandez J, Daluvoy SV, Soares MA, Chaudhry A, Mehrara BJ. TGF-beta1 is a negative regulator of lymphatic regeneration during wound repair. Am J Physiol Heart Circ Physiol. 2008 Nov;295(5):H2113-27. doi: 10.1152/ajpheart.00879.2008. Epub 2008 Oct 10.
PubMed 18849330Zampell JC, Yan A, Elhadad S, Avraham T, Weitman E, Mehrara BJ. CD4(+) cells regulate fibrosis and lymphangiogenesis in response to lymphatic fluid stasis. PLoS One. 2012;7(11):e49940. doi: 10.1371/journal.pone.0049940. Epub 2012 Nov 20.
PubMed 23185491Zhang B, Wang J, Gao J, Guo Y, Chen X, Wang B, Gao J, Rao Z, Chen Z. Alternatively activated RAW264.7 macrophages enhance tumor lymphangiogenesis in mouse lung adenocarcinoma. J Cell Biochem. 2009 May 1;107(1):134-43. doi: 10.1002/jcb.22110.
PubMed 19241443Sehgal VN, Srivastava G, Dogra S. Tacrolimus in dermatology-pharmacokinetics, mechanism of action, drug interactions, dosages, and side effects: part I. Skinmed. 2008 Jan-Feb;7(1):27-30. doi: 10.1111/j.1540-9740.2007.06485.x.
PubMed 18174798Gardenier JC, Kataru RP, Hespe GE, Savetsky IL, Torrisi JS, Nores GD, Jowhar DK, Nitti MD, Schofield RC, Carlow DC, Mehrara BJ. Topical tacrolimus for the treatment of secondary lymphedema. Nat Commun. 2017 Feb 10;8:14345. doi: 10.1038/ncomms14345.
PubMed 28186091
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malar Bags After Lower Lid Blepharoplasty and Facelift: A Randomized Controlled Trial of the Effects of Tacrolimus
- ClinicalTrials.gov ID
- NCT03715387
- Acronym / sponsor ID
- H17-02969
- Conditions
- Edema Face
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Elective lower eyelid surgery is a common cosmetic procedure. Facial swelling is a common complication. Studies suggest that this facial swelling is part of a complex inflammatory process. Topical tacrolimus has long been used to treat various inflammatory skin disorders. By combining our knowledge of facial swelling and tacrolimus mechanism of action, we can hypothesize that it can be used as a treatment to prevent this post-operative swelling. The purpose of this project is to apply topical tacrolimus to one of the patient's cheeks following facial surgery and compare the incidence of facial swelling to the opposite side control cheek.
Detailed description
1.0 Purpose:
To perform a randomized controlled trial to determine if topical tacrolimus ointment reduces incidence or severity of post-operative facial edema and malar bags after elective blepharoplasty and/or facelift.
2.0 Hypothesis:
Topical tacrolimus will reduce the incidence and severity of post-operative facial edema presenting as malar bags after blepharoplasty and/or facelift.
3.0 Justification:
Elective blepharoplasty is the fourth most common cosmetic procedures performed in North America. According to a report published by the American Society of Plastic Surgery, eye lid surgery accounted for 209,000 out of the 1.7 million cosmetic surgical procedures performed in 2016. Additionally, the number of eye lid surgeries rose 2% in 2016 compared to 2015 [ref 1].
Recurrent or worsened malar bags is a common complication of lower lid surgery. Studies suggest that post-operative lymphedema is a possible cause of these malar bags. Recent research into lymphedema pathophysiology shows that post-operative lymphedema is not simply a result of direct lymphatic injury, but rather a complex fibroproliferative inflammatory process.
Topical tacrolimus has long been used to treat various inflammatory skin disorders such as atopic dermatitis and psoriasis safely and effectively. By combining our knowledge of lymphedema pathophysiology and tacrolimus mechanism of action, we can hypothesize that it can be effectively used as a treatment to prevent post-operative malar bags as a result of lymphedema.
4.0 Objectives:
4.1. To apply topical tacrolimus ointment to a randomized cheek in sequential patients undergoing lower lid blepharoplasty, facelift or both and compare to the contralateral control cheek.
4.2. To determine if topical tacrolimus affects the incidence and severity of post-operative malar edema compared to the self-matched contralateral control cheek.
5.0 Research Design:
This is a double blinded randomized controlled trial involving an initial surgery followed by random topical drug treatment that is self matched to a contralateral control side. There will be 3 follow up visits for analysis.
6.0 Statistical Analysis:
6.1 Statistical Considerations
The primary endpoint is post operative malar edema which typically occurs 10-20% of the time following lower lid blepharoplasty and/or facelift procedures. If we expect to reduce the occurrence to 1-5% the number of patients required to achieve a significant result (α = 0.05 (2-sided), β = 0.20) is 40-100.
No increase in sample size has been made to account for losses to follow-up. In our practice over the past 10 years we have found that less than 1% of patients do not return for a follow-up visit.
6.2 Outcome Measures
A custom four point scale will be used to record the outcomes for each cheek:
I: No post operative edema. II: Mild post operative edema. III: Moderate post operative edema. IV: Severe post operative edema.
Example photographs will be provided to the blinded rater for each category.
6.3 Data Collection
Outcome measurements will be performed by a single observer who will be blinded to the contents of the containers and which cheek either was applied to. Data will be collected on study specific data collection forms.
7.0 Procedure
7.1 Surgical Procedure
The lower lid blepharoplasty and facelift procedures will be performed by Dr. Richard Warren in the usual fashion based on the patient's presenting problem. Specific differences in technique such as skin only excision vs fat transposition and ORL (Orbicularis Retaining Legament) division will be recorded and analyzed separately.
7.2 Tacrolimus Application
Patients will be given two containers labelled with "Right" and "Left" to be applied to their right and left cheeks respectively. The patients will apply the ointment once daily for 4 weeks post operatively. The contents of the containers will be randomized to either the treatment tacrolimus ointment or the control ointment which will be matched in colour and consistency to the tacrolimus ointment. They will be given instructions on applying the ointments based on FDA recommendations.
7.3 Choice of Tacrolimus Dose
The treatment containers will contain 0.1% tacrolimus ointment (marketed as PROTOPIC) based on FDA recommendations for adult patients. This dose of the drug is known to be sufficiently absorbed by inflamed skin reaching peak concentrations of 0.05-0.25ng/ml 3-6 hours after application. This is significantly lower than the accepted safe level of 5-20ng/ml established based on transplant research. [ref 16,17]
7.4 Post-operative Treatment
Patients will be followed post operatively in the office at 1 week, 4 weeks, and 6 months. Degree of post operative malar edema will be assessed by a single blinded observer. This will be recorded using a four point scale. Any side effects or adverse events will also be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will serve as their own self matched controls with one study cheek and one control cheek.
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus Treatment | Experimental | Drug: Tacrolimus Topical 0.1% Topical OintmentTacrolimus Topical 0.1% Topical Ointment |
| Control | Placebo comparator | Drug: Polysporin OintmentPatients will be self matched controls with one cheek receiving the study ointment and the other receiving a control ointment (polysporin ointment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Bilateral lower lid blepharoplasty, facelift, or both.
- Patients over 18 years of age.
Key exclusion criteria (13 listed)
- -Patients presenting for revision surgery.
- Patients with a known allergy to tacrolimus.
- Patients taking medications that alter tacrolimus metabolism:
- Anticonvulsants: carbamazepine, phenobarbital, phenytoin
- Antibiotics: rifampicin, rifabutin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tacrolimus Topical 0.1% Topical OintmentAlso: ProtopicTopical tacrolimus ointment | Drug | Tacrolimus Treatment |
| Polysporin OintmentAlso: PolysporinPolysporin ointment | Drug | Control |
Primary outcome
Malar edema
Time frame: 6 months
Development of malar edema post operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Background: PubMed 19327681Pessa JE, Garza JR. The malar septum: the anatomic basis of malar mounds and malar edema. Aesthet Surg J. 1997 Jan-Feb;17(1):11-7. doi: 10.1016/s1090-820x(97)70001-3.
- Background: PubMed 21211847Nagi KS, Carlson JA, Wladis EJ. Histologic assessment of dermatochalasis: elastolysis and lymphostasis are fundamental and interrelated findings. Ophthalmology. 2011 Jun;118(6):1205-10. doi: 10.1016/j.ophtha.2010.10.013. Epub 2011 Jan 6.
- Background: PubMed 20551850Nijhawan N, Marriott C, Harvey JT. Lymphatic drainage patterns of the human eyelid: assessed by lymphoscintigraphy. Ophthalmic Plast Reconstr Surg. 2010 Jul-Aug;26(4):281-5. doi: 10.1097/IOP.0b013e3181c32e57.
- Background: PubMed 24431347Kpodzo DS, Nahai F, McCord CD. Malar mounds and festoons: review of current management. Aesthet Surg J. 2014 Feb;34(2):235-48. doi: 10.1177/1090820X13517897. Epub 2014 Jan 15.
- Background: PubMed 21802319Cemal Y, Pusic A, Mehrara BJ. Preventative measures for lymphedema: separating fact from fiction. J Am Coll Surg. 2011 Oct;213(4):543-51. doi: 10.1016/j.jamcollsurg.2011.07.001. Epub 2011 Jul 28. No abstract available.
- Background: PubMed 25724493Ghanta S, Cuzzone DA, Torrisi JS, Albano NJ, Joseph WJ, Savetsky IL, Gardenier JC, Chang D, Zampell JC, Mehrara BJ. Regulation of inflammation and fibrosis by macrophages in lymphedema. Am J Physiol Heart Circ Physiol. 2015 May 1;308(9):H1065-77. doi: 10.1152/ajpheart.00598.2014. Epub 2015 Feb 27.
- Background: PubMed 23193171Avraham T, Zampell JC, Yan A, Elhadad S, Weitman ES, Rockson SG, Bromberg J, Mehrara BJ. Th2 differentiation is necessary for soft tissue fibrosis and lymphatic dysfunction resulting from lymphedema. FASEB J. 2013 Mar;27(3):1114-26. doi: 10.1096/fj.12-222695. Epub 2012 Nov 27.
- Background: PubMed 18849330Clavin NW, Avraham T, Fernandez J, Daluvoy SV, Soares MA, Chaudhry A, Mehrara BJ. TGF-beta1 is a negative regulator of lymphatic regeneration during wound repair. Am J Physiol Heart Circ Physiol. 2008 Nov;295(5):H2113-27. doi: 10.1152/ajpheart.00879.2008. Epub 2008 Oct 10.
- Background: PubMed 23185491Zampell JC, Yan A, Elhadad S, Avraham T, Weitman E, Mehrara BJ. CD4(+) cells regulate fibrosis and lymphangiogenesis in response to lymphatic fluid stasis. PLoS One. 2012;7(11):e49940. doi: 10.1371/journal.pone.0049940. Epub 2012 Nov 20.
- Background: PubMed 19241443Zhang B, Wang J, Gao J, Guo Y, Chen X, Wang B, Gao J, Rao Z, Chen Z. Alternatively activated RAW264.7 macrophages enhance tumor lymphangiogenesis in mouse lung adenocarcinoma. J Cell Biochem. 2009 May 1;107(1):134-43. doi: 10.1002/jcb.22110.
- Background: PubMed 18174798Sehgal VN, Srivastava G, Dogra S. Tacrolimus in dermatology-pharmacokinetics, mechanism of action, drug interactions, dosages, and side effects: part I. Skinmed. 2008 Jan-Feb;7(1):27-30. doi: 10.1111/j.1540-9740.2007.06485.x.
- Background: PubMed 28186091Gardenier JC, Kataru RP, Hespe GE, Savetsky IL, Torrisi JS, Nores GD, Jowhar DK, Nitti MD, Schofield RC, Carlow DC, Mehrara BJ. Topical tacrolimus for the treatment of secondary lymphedema. Nat Commun. 2017 Feb 10;8:14345. doi: 10.1038/ncomms14345.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Warren, MD principal investigator
University of British Columbia
Stahs Pripotnev, MD study chair
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tacrolimus Topical 0.1% Topical Ointment and Polysporin Ointment in people with Edema Face, run by University of British Columbia at 1 site in Canada.
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 2 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 23 Oct 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Warren, MD (604-876-1774, tracy@drwarren.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malar edema (time frame: 6 months). 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 NCT03715387, which also lists 12 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 23 Oct 2018.