Alopecia AreataPhase 2NCT01797432
Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata
A Phase 2 study testing Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) and Restylane in people with Alopecia Areata, run by University of Minnesota at 1 site in United States.
Trial summary
The investigators hypothesize that Restylane® could serve as a repair matrix which also maintains IL triamcinolone acetonide concentrations at higher levels for a longer period of time in the skin, giving a more sustained local anti-inflammatory effect and thus, arresting the AA process and promoting hair regrowth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) and Restylane
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ages 18 and greater.
- Alopecia areata diagnosis in the last two years with extensive scalp involvement, between 74% and 99%, alopecia areata must involve the left and right hemispheres of the scalp.
- Willing to abstain from use of over the counter products and prescription products, other than study medications, which may promote hair growth.
- Willing to abstain from the use of non-steroidal anti-inflammatory medications, aspirin, St. Johns Wart, and high doses of Vitamin E supplementation.
- Subjects are capable of giving informed consent.
- Willing to adhere to protocol, including scalp examinations and photography.
Who cannot join
- Allergy or intolerance to Restylane® or hyaluronate preparations
- Allergy or intolerance to triamcinolone acetonide, 10 mg/cc.
- Underlying disease that might be adversely affected by Restylane® or triamcinolone (ex. patients with bleeding disorders).
- Immunosuppressed patients (history of transplantation, cancer, chemotherapy, splenectomy, HIV).
- Pregnant or lactating female.
- Application of topical immunomodulatory or immunosuppressive agent in the preceding 6 weeks.
Show all 14Show fewer
- Systemic administration of corticosteroid or other systemic treatment (i.e. prednisone) that has immunomodulatory or other immunosuppressive mechanism of action, in the preceding 8 weeks.
- Clinical evidence of secondary skin infection (i.e., folliculitis).
- Other inflammatory or infectious skin disease that might interfere with evaluations during the study.
- Investigational medications within the past 30 days.
- Patients with susceptibility to keloid formation.
- Severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies
- Patients with allergies to gram positive bacterial proteins
- Unable to give consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, 55455
About this study
Official title: Safety and Efficacy of Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata
The investigators hypothesize that Restylane® could serve as a repair matrix which also maintains IL triamcinolone acetonide concentrations at higher levels for a longer period of time in the skin, giving a more sustained local anti-inflammatory effect and thus, arresting the AA process and promoting hair regrowth. Furthermore, the combination of Restylane® with IL triamcinolone acetonide injections may prevent a common side effect, atrophy. With the prevention of scalp atrophy and the preservation of higher concentrations of triamcinolone acetonide for longer periods of time, patients may see a better clinical response for a longer period of time. Quality of life may improve as the number of clinic visits decreases as would the number of IL corticosteroid injections.
- Conditions
- Alopecia Areata
- Being tested
- Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10), Restylane
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10)Drug
Also called Kenalog-10
Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp
RestylaneDevice
Intralesional injections of 2mLs of Restylane on one side of the scalp
| Study group | Role | What they receive |
|---|---|---|
| Combined IL Kenalog and Restylane | Experimental | Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp Receives: Drug: Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10); Device: Restylane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alopecia Areata Half Head Severity Score (AAHHSS) at 12 Weeks Compared to Baseline
The primary endpoint of evaluating the efficacy of administration of IL triamcinolone acetonide 10 mg/cc and Restylane® in the management of AA is the alopecia areata half head severity score (AAHHSS) comparing week 12 with baseline hair loss. Four discreet areas of the scalp are examined. The percent of terminal hair loss in each area is measured by visual estimation. Those percent figures are multiplied by the total area on one half of the scalp represented by the four respective areas. 1) Left parietal scalp (18% of area), right parietal scalp (18% of area), frontal scalp (40% of area), and occipital scalp (24% of area). Scores range from 0 to 50, with higher scores indicating more hair loss.
Measured: 12 weeks
Secondary outcomes (1)
Number of Adverse Events Reported by Subjects
To assess the safety of IL triamcinolone acetonide 10 mg/cc and Restylane® in the management of AA.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startMar 2009
- Primary completionNov 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Hordinsky, MD, Principal investigator, University of Minnesota - Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797432
- Sponsor's protocol ID
- 0907M69801
- Status last verified
- Dec 2020
- First submitted
- 6 Jul 2012
- Last updated
- 12 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata
- ClinicalTrials.gov ID
- NCT01797432
- Acronym / sponsor ID
- 0907M69801
- Conditions
- Alopecia Areata
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Posted 12 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that Restylane® could serve as a repair matrix which also maintains IL triamcinolone acetonide concentrations at higher levels for a longer period of time in the skin, giving a more sustained local anti-inflammatory effect and thus, arresting the AA process and promoting hair regrowth. Furthermore, the combination of Restylane® with IL triamcinolone acetonide injections may prevent a common side effect, atrophy. With the prevention of scalp atrophy and the preservation of higher concentrations of triamcinolone acetonide for longer periods of time, patients may see a better clinical response for a longer period of time. Quality of life may improve as the number of clinic visits decreases as would the number of IL corticosteroid injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined IL Kenalog and Restylane | Experimental | Drug: Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10), Device: RestylaneInjection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women ages 18 and greater.
- Alopecia areata diagnosis in the last two years with extensive scalp involvement, between 74% and 99%, alopecia areata must involve the left and right hemispheres of the scalp.
- Willing to abstain from use of over the counter products and prescription products, other than study medications, which may promote hair growth.
- Willing to abstain from the use of non-steroidal anti-inflammatory medications, aspirin, St. Johns Wart, and high doses of Vitamin E supplementation.
- Subjects are capable of giving informed consent.
Key exclusion criteria (14 listed)
- Allergy or intolerance to Restylane® or hyaluronate preparations
- Allergy or intolerance to triamcinolone acetonide, 10 mg/cc.
- Underlying disease that might be adversely affected by Restylane® or triamcinolone (ex. patients with bleeding disorders).
- Immunosuppressed patients (history of transplantation, cancer, chemotherapy, splenectomy, HIV).
- Pregnant or lactating female.
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 |
|---|---|---|
| Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10)Also: Kenalog-10Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp | Drug | Combined IL Kenalog and Restylane |
| RestylaneIntralesional injections of 2mLs of Restylane on one side of the scalp | Device | Combined IL Kenalog and Restylane |
Primary outcome
Change in Alopecia Areata Half Head Severity Score (AAHHSS) at 12 Weeks Compared to Baseline
Time frame: 12 weeks
The primary endpoint of evaluating the efficacy of administration of IL triamcinolone acetonide 10 mg/cc and Restylane® in the management of AA is the alopecia areata half head severity score (AAHHSS) comparing week 12 with baseline hair loss. Four discreet areas of the scalp are examined. The percent of terminal hair loss in each area is measured by visual estimation. Those percent figures are multiplied by the total area on one half of the scalp represented by the four respective areas. 1) Left parietal scalp (18% of area), right parietal scalp (18% of area), frontal scalp (40% of area), and occipital scalp (24% of area). Scores range from 0 to 50, with higher scores indicating more hair loss.
1 secondary outcome
Number of Adverse Events Reported by Subjects
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Alopecia Areata
Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata
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.
Maria Hordinsky, MD principal investigator
University of Minnesota - Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) and Restylane in people with Alopecia Areata, run by University of Minnesota at 1 site in United States.
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 6 inclusion and 14 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 12 Jan 2021. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Alopecia Areata Half Head Severity Score (AAHHSS) at 12 Weeks Compared to Baseline (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2021.