Intralesional Steroids in the Treatment of Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: Intralesional Triamcinolone 2.5 mg/ml; Intralesional Triamcinolone 5 mg/ml; Intralesional Triamcinolone 10 mg/ml; Intralesional Saline
Intervention description: 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 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 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 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.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Alopecia Areata; Kenalog; Triamcinolone

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). 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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

          -  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