Timolol for the Treatment of Acne and Rosacea

NCT02774590 | Completed Phase 1

• 1 other identifier: IRB00074049
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Acne Vulgaris; Rosacea

Keywords

Acne vulgaris; Rosacea

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of timolol for acne and rosacea as assessed by subject report

  To determine the safety and tolerability of Timolol in the treatment of acne and rosacea

  8 weeks

• Safety and tolerability of timolol for acne and rosacea as assessed by physician assessment

  To determine the safety and tolerability of Timolol in the treatment of acne and rosacea

  8 weeks

Secondary Outcomes (3)

• Decrease of rosacea activity as assessed through visual assessments (photographs, chronometer, patient report and physician examination)

  8 weeks

• Decrease of acne activity: papules

  8 weeks

• Test if the DNA methylation patterns are corrected following clinical improvement as assessed by microarray

  8 weeks

Study Arms (1)

Timolol to split face for 8 weeks

EXPERIMENTAL

All 24 subjects will receive study drug and everyone will be randomized to which side of the face is treated with study drug first (right half-face versus left half-face). After 8 weeks of split-face treatment every night before bed, the subjects will be instructed to start treating both sides for another 8 weeks. Up to 30 subjects may be enrolled to ensure a target sample size of 24 (12 acne cases, 12 rosacea cases). This is an exploratory study. No part of this protocol will be considered routine care.

Drug: Timolol

Interventions

Timolol DRUG

Apply timolol on half of the participant's face for 8 weeks. Then treat both sides of face for 8 weeks.

Timolol to split face for 8 weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• o 10-100 noninflammatory, 20-50 inflammatory lesions (nose excluded)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Dermatology Department

Baltimore, Maryland, 21209, United States

Location

Related Publications (1)

• Tsai J, Chien AL, Kim N, Rachidi S, Connolly BM, Lim H, Alessi Cesar SS, Kang S, Garza LA. Topical timolol 0.5% gel-forming solution for erythema in rosacea: A quantitative, split-face, randomized, and rater-masked pilot clinical trial. J Am Acad Dermatol. 2021 Oct;85(4):1044-1046. doi: 10.1016/j.jaad.2021.01.098. Epub 2021 Feb 3. No abstract available.

  PMID: 33548303 RESULT

MeSH Terms

Conditions

Acne Vulgaris; Rosacea

Interventions

Timolol

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Officials

• Luis A Garza, MD, PhD

  Johns Hopkins Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 17, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)