Alopecia AreataPhase 4NCT01898806
Intralesional Steroids in the Treatment of Alopecia Areata
A Phase 4 study testing Intralesional Triamcinolone 2.5 mg/ml, Intralesional Triamcinolone 5 mg/ml and Intralesional Triamcinolone 10 mg/ml in people with Alopecia Areata, run by Columbia University at 2 sites in United States.
Trial summary
This study aims to determine the frequency of response to treatment with 3 concentrations of IL TAC, 2.5mg/ml, 5mg/ml or 10mg/ml as well as the duration of response and incidence of side effects compared to treatment with placebo (sterile saline solution). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Intralesional Triamcinolone 2.5 mg/ml, Intralesional Triamcinolone 5 mg/ml and Intralesional Triamcinolone 10 mg/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2011to Jan 2018
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 to 75 years of age
- Patients with a diagnosis of patch type alopecia areata
- Patients will have up to 50% total scalp hair loss at baseline as measured by the Severity of Alopecia Tool (SALT) score
- Duration of hair loss ranging from 3 to 12 months with no evidence of regrowth present at baseline in the areas to be injected
Who cannot join
- Patients with a history of or existing skin diseases affecting the scalp such as psoriasis or seborrheic dermatitis and patients with evidence of infection or skin cancer in the treated areas
- Patients in whom the diagnosis of alopecia areata is questionable
- Patients in whom regrowth is present/evident at baseline in the areas to be treated
- Patients with active medical conditions or malignancies (except adequately treated basal or squamous cell carcinoma of the skin) which in the opinion of the investigator would increase the risks associated with study participation, including patients with a history of recurrent infections
- Women of childbearing potential who are unable or unwilling to use two forms of birth control for the study duration or women who are pregnant or nursing
- Patients known to be HIV or hepatitis B or C positive or otherwise immunocompromised
Show all 9Show fewer
- Patients with evidence of adrenal cortex abnormality or previous significant adverse reaction to intralesional steroids
- Patients unwilling or unable to discontinue treatments known to affect hair regrowth in alopecia areata
- Patients who have been treated with intralesional steroids, systemic steroids, anthralin, squaric acid, diphenylcyclopropenone (DPCP), protopic, minoxidil or other medication which in the opinion of the investigator may affect hair regrowth, within one month of the baseline visit
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota
Minneapolis, Minnesota, 55455
Columbia University Medical Center, Department of Dermatology
New York, New York, 10032
About this study
Official title: A Phase 4 Multicenter, Randomized, Placebo Controlled Trial of 3 Doses of Intralesional Triamcinolone (KENALOG®) In the Treatment of Mild to Moderate Patch Type Alopecia Areata
This study aims to determine the frequency of response to treatment with 3 concentrations of IL TAC, 2.5mg/ml, 5mg/ml or 10mg/ml as well as the duration of response and incidence of side effects compared to treatment with placebo (sterile saline solution). After the 1st 6 months, nonresponders or partial responders may be treated for 6 months with open label triamcinolone at the dose deemed appropriate by the investigator.
The investigators will also perform skin biopsies of the scalp and draw blood at selected time points in order to examine the immunohistochemical/pathological response in scalp hair follicles and the systemic circulation to treatment with IL TAC for alopecia areata.
Read the detailed description
Alopecia areata (AA) is a major medical problem and is the most prevalent autoimmune disease in the US. AA represents the second most common form of hair loss and causes significant disfigurement and psychological distress to affected individuals. AA affects more individuals than most other autoimmune diseases combined, including lupus erythematosus, type 1 diabetes, psoriasis, multiple sclerosis and rheumatoid arthritis. In contrast to these conditions, research into the pathogenesis and the development of innovative therapies in AA has lagged behind.
Alopecia areata is a common form of hair loss which reportedly occurs in up to 1.7% of the population at some time in their life. Alopecia areata is apparently triggered when the individual's own immune system attacks hair follicles on the scalp or body resulting in hair loss ranging from single patches on the scalp (patch type alopecia areata) to loss of every hair on the scalp and body (alopecia universalis). Currently, there are limited treatment options for alopecia areata and unfortunately, the treatments utilized have never been rigorously tested in a placebo controlled trial.
Triamcinolone (Kenalog) is a steroid solution that has been used as a treatment for alopecia areata for over 50 years. It is administered via injection into the scalp and appears to have some efficacy for patients with mild to moderate alopecia areata. The investigators currently do not have objective data on the frequency of occurrence of successful regrowth, the duration of response or the incidence of side effects. Intralesional triamcinolone (IL TAC) is arguably the most commonly used treatments for AA, especially in patients with less than 50% hair loss. Despite this, there are no adequately powered, randomized controlled clinical trials (RCTs) examining the efficacy, safety, and duration of effect of IL TAC. In addition, the dosage or strength used varies among practitioners and the efficacy and safety of alternate doses of IL TAC has never been examined in a well designed RCT. Quantitative biomarkers for AA are a crucial step toward translational research aimed at clinical trials in AA.
- Conditions
- Alopecia Areata
- Being tested
- Intralesional Triamcinolone 2.5 mg/ml, Intralesional Triamcinolone 5 mg/ml, Intralesional Triamcinolone 10 mg/ml, Intralesional Saline
- Keywords
- Alopecia Areata, Kenalog, Triamcinolone
- 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 2.5 mg/mlDrug
Also called Kenalog, IL TAC 2.5 mg/ml
Intralesional Triamcinolone at a strength of 2.5 mg/ml. Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss up to the maximum dose of 30 mg IL TAC per month, for a total of 6 months.
Intralesional Triamcinolone 5 mg/mlDrug
Also called Kenalog, IL TAC 5 mg/ml
Intralesional Triamcinolone at a strength of 5 mg/ml. Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss up to the maximum dose of 30 mg IL TAC per month, for a total of 6 months.
Intralesional Triamcinolone 10 mg/mlDrug
Also called Kenalog, IL TAC 10 mg/ml
Intralesional Triamcinolone at a strength of 10 mg/ml. Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss up to the maximum dose of 30 mg IL TAC per month, for a total of 6 months.
Intralesional SalineDrug
Also called Placebo
Intralesional Saline (Placebo). Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss for a total of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| IL TAC 2.5 mg/ml | Experimental | Intralesional Triamcinolone 2.5 mg/ml (IL TAC 2.5 mg/ml):
Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss up to the maximum dose of 30 mg IL TAC per month, for a total of 6 months. Injections will be performed at baseline, weeks 4, 8, 12, 16 and 20 Receives: Drug: Intralesional Triamcinolone 2.5 mg/ml |
| IL TAC 5 mg/ml | Experimental | Intralesional Triamcinolone 5mg/ml (IL TAC 5 mg/ml):
Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss up to the maximum dose of 30 mg IL TAC per month, for a total of 6 months. Injections will be performed at baseline, weeks 4, 8, 12, 16 and 20. Receives: Drug: Intralesional Triamcinolone 5 mg/ml |
| IL TAC 10 mg/ml | Experimental | Intralesional Triamcinolone 10mg/ml (IL TAC 10 mg/ml):
Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss up to the maximum dose of 30 mg IL TAC per month, for a total of 6 months. Injections will be performed at baseline, weeks 4, 8, 12, 16 and 20. Receives: Drug: Intralesional Triamcinolone 10 mg/ml |
| Placebo | Placebo comparator | Intralesional Saline (Placebo):
Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss for a total of 6 months. Injections will be performed at baseline, weeks 4, 8, 12, 16 and 20. Open label treatment with IL kenalog at the dose deemed most appropriate may be administered after the 1st 6 months in nonresponders or partial responders. Receives: Drug: Intralesional Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Responders
Comparison of the proportion of responders in each group, with response defined as 50% change (% change NOT absolute change) in SALT score from baseline (50% regrowth at week 24).
Measured: Up to 48 weeks
Secondary outcomes (1)
Number of Adverse Events
Incidence and severity of adverse events (AEs) including the presence and degree of skin atrophy, as well as incidence of treatment-emergent laboratory abnormalities.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startSep 2011
- Primary completionJan 2018
- Study completionJan 2018
Why it stopped: The PI left the Columbia University Medical Center. Study was not Completed.
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 Columbia UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Julian Mackay-Wiggan, MD, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898806
- Sponsor's protocol ID
- AAAI5852
- Status last verified
- Jun 2019
- First submitted
- 10 Jul 2013
- Last updated
- 6 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Multicenter, Randomized, Placebo Controlled Trial of 3 Doses of Intralesional Triamcinolone (KENALOG®) In the Treatment of Mild to Moderate Patch Type Alopecia Areata
- ClinicalTrials.gov ID
- NCT01898806
- Acronym / sponsor ID
- AAAI5852
- Conditions
- Alopecia Areata
- Keywords
- Alopecia Areata, Kenalog, Triamcinolone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The PI left the Columbia University Medical Center. Study was not Completed.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- Sep 2011 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Posted 6 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the frequency of response to treatment with 3 concentrations of IL TAC, 2.5mg/ml, 5mg/ml or 10mg/ml as well as the duration of response and incidence of side effects compared to treatment with placebo (sterile saline solution). After the 1st 6 months, nonresponders or partial responders may be treated for 6 months with open label triamcinolone at the dose deemed appropriate by the investigator.
The investigators will also perform skin biopsies of the scalp and draw blood at selected time points in order to examine the immunohistochemical/pathological response in scalp hair follicles and the systemic circulation to treatment with IL TAC for alopecia areata.
Detailed description
Alopecia areata (AA) is a major medical problem and is the most prevalent autoimmune disease in the US. AA represents the second most common form of hair loss and causes significant disfigurement and psychological distress to affected individuals. AA affects more individuals than most other autoimmune diseases combined, including lupus erythematosus, type 1 diabetes, psoriasis, multiple sclerosis and rheumatoid arthritis. In contrast to these conditions, research into the pathogenesis and the development of innovative therapies in AA has lagged behind.
Alopecia areata is a common form of hair loss which reportedly occurs in up to 1.7% of the population at some time in their life. Alopecia areata is apparently triggered when the individual's own immune system attacks hair follicles on the scalp or body resulting in hair loss ranging from single patches on the scalp (patch type alopecia areata) to loss of every hair on the scalp and body (alopecia universalis). Currently, there are limited treatment options for alopecia areata and unfortunately, the treatments utilized have never been rigorously tested in a placebo controlled trial.
Triamcinolone (Kenalog) is a steroid solution that has been used as a treatment for alopecia areata for over 50 years. It is administered via injection into the scalp and appears to have some efficacy for patients with mild to moderate alopecia areata. The investigators currently do not have objective data on the frequency of occurrence of successful regrowth, the duration of response or the incidence of side effects. Intralesional triamcinolone (IL TAC) is arguably the most commonly used treatments for AA, especially in patients with less than 50% hair loss. Despite this, there are no adequately powered, randomized controlled clinical trials (RCTs) examining the efficacy, safety, and duration of effect of IL TAC. In addition, the dosage or strength used varies among practitioners and the efficacy and safety of alternate doses of IL TAC has never been examined in a well designed RCT. Quantitative biomarkers for AA are a crucial step toward translational research aimed at clinical trials in AA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IL TAC 2.5 mg/ml | Experimental | Drug: Intralesional Triamcinolone 2.5 mg/mlIntralesional Triamcinolone 2.5 mg/ml (IL TAC 2.5 mg/ml): Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss up to the maximum dose of 30 mg IL TAC per month, for a total of 6 months. Injections will be performed at baseline, weeks 4, 8, 12, 16 and 20 |
| IL TAC 5 mg/ml | Experimental | Drug: Intralesional Triamcinolone 5 mg/mlIntralesional Triamcinolone 5mg/ml (IL TAC 5 mg/ml): Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss up to the maximum dose of 30 mg IL TAC per month, for a total of 6 months. Injections will be performed at baseline, weeks 4, 8, 12, 16 and 20. |
| IL TAC 10 mg/ml | Experimental | Drug: Intralesional Triamcinolone 10 mg/mlIntralesional Triamcinolone 10mg/ml (IL TAC 10 mg/ml): Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss up to the maximum dose of 30 mg IL TAC per month, for a total of 6 months. Injections will be performed at baseline, weeks 4, 8, 12, 16 and 20. |
| Placebo | Placebo comparator | Drug: Intralesional SalineIntralesional Saline (Placebo): Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss for a total of 6 months. Injections will be performed at baseline, weeks 4, 8, 12, 16 and 20. Open label treatment with IL kenalog at the dose deemed most appropriate may be administered after the 1st 6 months in nonresponders or partial responders. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 to 75 years of age
- Patients with a diagnosis of patch type alopecia areata
- Patients will have up to 50% total scalp hair loss at baseline as measured by the Severity of Alopecia Tool (SALT) score
- Duration of hair loss ranging from 3 to 12 months with no evidence of regrowth present at baseline in the areas to be injected
Key exclusion criteria (9 listed)
- Patients with a history of or existing skin diseases affecting the scalp such as psoriasis or seborrheic dermatitis and patients with evidence of infection or skin cancer in the treated areas
- Patients in whom the diagnosis of alopecia areata is questionable
- Patients in whom regrowth is present/evident at baseline in the areas to be treated
- Patients with active medical conditions or malignancies (except adequately treated basal or squamous cell carcinoma of the skin) which in the opinion of the investigator would increase the risks associated with study participation, including patients with a history of recurrent infections
- Women of childbearing potential who are unable or unwilling to use two forms of birth control for the study duration or women who are pregnant or nursing
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 2.5 mg/mlAlso: Kenalog, IL TAC 2.5 mg/mlIntralesional Triamcinolone at a strength of 2.5 mg/ml. Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss up to the maximum dose of 30 mg IL TAC per month, for a total of 6 months. | Drug | IL TAC 2.5 mg/ml |
| Intralesional Triamcinolone 5 mg/mlAlso: Kenalog, IL TAC 5 mg/mlIntralesional Triamcinolone at a strength of 5 mg/ml. Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss up to the maximum dose of 30 mg IL TAC per month, for a total of 6 months. | Drug | IL TAC 5 mg/ml |
| Intralesional Triamcinolone 10 mg/mlAlso: Kenalog, IL TAC 10 mg/mlIntralesional Triamcinolone at a strength of 10 mg/ml. Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss up to the maximum dose of 30 mg IL TAC per month, for a total of 6 months. | Drug | IL TAC 10 mg/ml |
| Intralesional SalineAlso: PlaceboIntralesional Saline (Placebo). Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss for a total of 6 months. | Drug | Placebo |
Primary outcome
Proportion of Responders
Time frame: Up to 48 weeks
Comparison of the proportion of responders in each group, with response defined as 50% change (% change NOT absolute change) in SALT score from baseline (50% regrowth at week 24).
1 secondary outcome
Number of Adverse Events
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Julian Mackay-Wiggan, MD, MS principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intralesional Triamcinolone 2.5 mg/ml, Intralesional Triamcinolone 5 mg/ml and Intralesional Triamcinolone 10 mg/ml in people with Alopecia Areata, run by Columbia University at 2 sites 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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 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?
Yes. Results are posted in the registry (first posted 6 Jun 2019). 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?
Proportion of Responders (time frame: Up to 48 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 6 Jun 2019.