Alopecia Areata
Conditions
Brief 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. 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.
Interventions
DRUGIntralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10)
Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp
DEVICERestylane
Intralesional injections of 2mLs of Restylane on one side of the scalp
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men and women ages 18 and greater. 2. 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. 3. Willing to abstain from use of over the counter products and prescription products, other than study medications, which may promote hair growth. 4. Willing to abstain from the use of non-steroidal anti-inflammatory medications, aspirin, St. Johns Wart, and high doses of Vitamin E supplementation. 5. Subjects are capable of giving informed consent. 6. Willing to adhere to protocol, including scalp examinations and photography.
Exclusion criteria
1. Allergy or intolerance to Restylane® or hyaluronate preparations 2. Allergy or intolerance to triamcinolone acetonide, 10 mg/cc. 3. Underlying disease that might be adversely affected by Restylane® or triamcinolone (ex. patients with bleeding disorders). 4. Immunosuppressed patients (history of transplantation, cancer, chemotherapy, splenectomy, HIV). 5. Pregnant or lactating female. 6. Application of topical immunomodulatory or immunosuppressive agent in the preceding 6 weeks. 7. 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. 8. Clinical evidence of secondary skin infection (i.e., folliculitis). 9. Other inflammatory or infectious skin disease that might interfere with evaluations during the study. 10. Investigational medications within the past 30 days. 11. Patients with susceptibility to keloid formation. 12. Severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies 13. Patients with allergies to gram positive bacterial proteins 14. Unable to give consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alopecia Areata Half Head Severity Score (AAHHSS) at 12 Weeks Compared to Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events Reported by Subjects | 12 weeks | To assess the safety of IL triamcinolone acetonide 10 mg/cc and Restylane® in the management of AA. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Combined IL Kenalog and Restylane Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp
Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10): Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp
Restylane: Intralesional injections of 2mLs of Restylane on one side of the scalp | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | lived too far from study site | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Combined IL Kenalog and Restylane |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 41.43 years STANDARD_DEVIATION 18.98 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 11 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined IL Kenalog and Restylane | Change in Alopecia Areata Half Head Severity Score (AAHHSS) at 12 Weeks Compared to Baseline | -17.75 score on a scale | Standard Deviation 23.36 |
Secondary
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.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combined IL Kenalog and Restylane | Number of Adverse Events Reported by Subjects | 25 adverse events |