Timolol for the Treatment of Acne and Rosacea

• Status: Completed
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Timolol

Criteria

Inclusion Criteria:

• 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:

o 10-100 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 56.6-59.6). Example from (Helfrich et al., 2015).

o 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

o Biopsy volunteer specific exclusion criteria: History of keloids History of hypertrophic scars Allergy to lidocaine or epinephrine