Timolol for the Treatment of Acne and Rosacea

  • STATUS
    Recruiting
  • End date
    Mar 16, 2025
  • participants needed
    24
  • sponsor
    Johns Hopkins University
Updated on 16 March 2020
Investigator
Bao Chau Ly, M.S.
Primary Contact
Johns Hopkins Dermatology Department (6.7 mi away) Contact
erythema
skin disorder
blackheads
rosacea
acne
flushing

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

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.

Details
Treatment Timolol
Clinical Study IdentifierNCT02774590
SponsorJohns Hopkins University
Last Modified on16 March 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: Acne Vulgaris or Skin Conditions or Dermatosis or Congenital Skin Diseases or Acne or Rosacea?
In the opinion of the investigator, must be medically able to undergo the administration of study material
Be able to comprehend the informed consent document and provide consent for participation
Females of childbearing potential must
Not be pregnant by subjective report
agree to not become pregnant or breastfeed for the period of the study through 1 month after completion of the study
be willing to use a reliable form of contraception during the study
Be willing and able to comply with the scheduled visits and other study procedures for the duration of the study
Be willing not to take any other medicine for acne or rosacea during the study
Acne specific inclusion criteria
-100 noninflammatory, 20-50 inflammatory lesions (nose excluded)
Rosacea specific inclusion criteria
History of frequent flushing
Skin erythema - Positive (not negative) chromometer minimum reading difference when subtracting nonaffected reading from affected reading
Goal would be greater than 1 unit difference between red areas. For example
the red area (average 17.7 Chroma Meter a) and nonaffected areas (average 14.1
Chroma Meter a), yields in an optimum scenario greater than 3 point difference
in this example (in subjects with average Chromometer L value averaging
6-59.6). Example from (Helfrich et al., 2015)
Presence of inflammatory papules

Exclusion Criteria

Having received any investigational drug within 30 days prior to study entry
An allergy history to any study materials including any beta-blockers
Pregnant, lactating, or trying to become pregnant
Severe depression
Hypotension or history
Bradycardia or history
History of Cardiac Heart Failure
History of Myocardial infarction
History of heart arrhythmia
Asthma or Bronchospasm or history
Rosacea specific exclusion criteria
Recent topicals within 3 weeks Oral rosacea medications such as antibiotics
within 3 weeks Acne specific exclusion criteria: nodular acne man with beard
which interferes with clinical evaluation history of Accutane Oral
contraceptive pills changes last 3 months Topical retinoid within 4 weeks
Cosmetic procedures (like facial or peels) for 4 weeks Photodynamic therapy
laser therapy or microdermabrasion for 4 weeks Other topicals or oral acne
medications such as antibiotics within 3 weeks
Biopsy volunteer specific exclusion criteria: History of keloids History of hypertrophic scars Allergy to lidocaine or epinephrine
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