Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata
| Status: | Completed |
|---|---|
| Conditions: | Dermatology, Hair Loss |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2009 |
| End Date: | December 2015 |
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
