Timolol for the Treatment of Acne and Rosacea
Condition: Acne Vulgaris; Rosacea
MeSH terms: Acne Vulgaris; Rosacea
Study type: Interventional
Phase: Phase 1

Summary: 
      This research is being done to determine the safety and tolerability of timolol in the
      treatment of acne and rosacea. The investigators will also look for specific biomolecular
      changes in acne or rosacea skin when it is exposed to timolol.

      Timolol is approved by the Food and Drug Administration (FDA) for the treatment of glaucoma.
      In dermatology, it has been used as a treatment to decrease the size of vascular (blood
      vessel) malformations in infant skin. Timolol is not approved for use in acne or rosacea and
      its use in this study is investigational.

      Many people with rosacea have telangiectasias which are small, red dilated blood vessels on
      the skin. They also suffer from flushing and acne-like lesions. Better treatments than those
      currently available are desired.

      Acne vulgaris, or acne, is another chronic inflammatory and very common skin disease that
      affects about 8 out of 10 young adults and adolescents. Signs of acne include papules and
      blackheads that are often called primary lesions because they represent an active form of the
      disease. There are also secondary lesions that can form later; they are known as acne scars
    

Detailed description: 
      Rosacea affects roughly 16 million Americans who desire better treatments than those
      currently available. Acne vulgaris, another chronic inflammatory skin disorder, mainly
      affects teenagers but also affects 20-40% of adults. Investigating potential new treatments
      will not only satisfy a clinical need, but also offers the opportunity to learn about the
      pathogenesis of the disease and skin biology. The purpose of this study is to investigate the
      possible role of timolol as a therapy for the erythema and papules associated with acne and
      rosacea. It has been shown that timolol is beneficial and safe to treat infantile
      hemangiomas. The investigators hypothesize that it may also be safe and effective in the
      treatment of acne and rosacea.

      In a single experiment where the test case was the PI (a practicing physician), the
      investigators treated his rosacea with timolol for this off-label indication and have noticed
      an improvement in flushing and an unexpected improvement in acneiform eruptions associated
      with the rosacea. After 30 days, less flushing and acneiform lesions were noted on the
      treated right side compared to the left side . Similarly, at 60 days after treatment, as
      visualized by infrared imaging, significantly less inflammation and flushing was noted on the
      treated right side even outside of episodes of flushing. The improvement was durable, such
      that after a 60 day washout, improvements were still noted. In summary, during testing of the
      PI as a case subject, timolol appeared effective, safe, and with some disease-remissive
      effects.

      Our aim is to conduct a 16 week split-face pilot study with up to 30 patients who have a
      diagnosis of either inflammatory acne or rosacea to assess whether timolol maleate
      effectively reduces erythema, flushing, telangiectasias, and/or papules. The investigators
      also propose to biopsy a subset of our study patients to examine the biological activity in
      the skin before and after treatment. The investigators are particularly interested in
      studying epigenetic DNA methylation abnormalities in these conditions at baseline to compare
      to normal subjects and as a result of therapy.
    

Intervention name(s): Timolol
Intervention type(s): Drug
Intervention description(s): Apply timolol on half of the participant's face for 8 weeks. Then treat both sides of face for 8 weeks.
Intervention MeSH terms: Timolol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acne vulgaris; Rosacea