Phase 2
N=14
Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata
Alopecia Areata
Bottom Line
View on ClinicalTrials.gov: NCT01797432 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Change in Alopecia Areata Half Head Severity Score (AAHHSS) at 12 Weeks Compared to Baseline — -17.75 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) (Drug); Restylane (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Alopecia Areata Half Head Severity Score (AAHHSS) at 12 Weeks Compared to Baseline |
-17.75 | — |
| SECONDARY Number of Adverse Events Reported by Subjects |
25 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT01797432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.