Efficacy and Safety of 0.25% Timolol Gel in Healing Surgical Open Wounds

NCT03452072 | Completed Phase 2 FDA Drug

• 1 other identifier: BWHMDSC001
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The use of topical beta-blockers, such as 0.25% timolol, in promoting wound healing is currently emerging in the academic literature. The investigators will enroll 114 patients who have their skin cancer surgically removed resulting in open surgical wounds less or equal to 1.5 cm. The objective of this randomized safety study is to determine the safety and efficacy of 0.25% timolol in promoting wound healing in open surgical wounds less or equal to 1.5 cm.

Conditions

Wound of Skin; Wound Heal; Wound Open; Surgical Wound

Outcome Measures

Primary Outcomes (1)

• Change in histogram planimetry for open surgical wounds

  Histogram planimetry is more accessible and less expensive than automated analysis software programs, and it is based on the pixel count of a selected irregular area which is divided by the pixel count of 1 cm2 to find a result in terms of cm2 or mm2

  7 days' post-surgery, 15 days' post-surgery, 30 days' post-surgery, 3 months' post-surgery, 6 months' post-surgery

Secondary Outcomes (3)

• Cosmetic outcomes of open surgical wound healing by blinded physician Vancouver Scar Scale assessment

  3 months' post-surgery, 6 months' post-surgery

• Study subject complete the Patient Scar Assessment via Visual Analogue Scale

  3 months' post-surgery, 6 months' post-surgery

• Determine side effects associated with 0.25% topical timolol for open surgical wounds

  7 days' post-surgery, 15 days' post-surgery, 30 days' post-surgery, 3 months' post-surgery, 6 months' post-surgery

Study Arms (2)

0.25% Timolol gel under the paraffin gauzes

EXPERIMENTAL

1. Timolol 0.25% gel will be applied to wound bed immediately after surgery before dressing is applied 2. Starting the day after surgery: each day, the patient will cleanse the surgical site, apply 0.25% topical timolol gel (1 drop = 0.1ml for each cm2 of wound area), and re-cover wound with clean dressing 3. This daily routine continues for 12 weeks' post-surgery (even if the surgical defect has completely healed in the interim)

Drug: 0.25% Timolol gel with paraffin gauze dressings

Standard of Care dressings

ACTIVE COMPARATOR

1. Vaseline will be applied to wound bed immediately after surgery before dressing is applied 2. Starting the day after surgery: each day, the patient will cleanse the surgical site, apply Vaseline, and re-cover wound with clean dressing 3. This daily routine continues for 12 weeks' post-surgery (even if the surgical defect has completely healed in the interim)

Other: Vaseline dressing

Interventions

0.25% Timolol gel with paraffin gauze dressings DRUG

Timolol 0.25% gel will be applied to wound bed immediately after surgery before dressing is applied. Starting the day after surgery: each day, the patient will cleanse the surgical site, apply 0.25% topical timolol gel (1 drop = 0.1ml for each cm2 of wound area), and re-cover wound with clean dressing

0.25% Timolol gel under the paraffin gauzes

Vaseline dressing OTHER

Vaseline will be applied to wound bed immediately after surgery before dressing is applied. Starting the day after surgery: each day, the patient will cleanse the surgical site, apply Vaseline, and re-cover wound with clean dressing

Standard of Care dressings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years
• Open surgical wound ≤1.5cm
• No hypersensitivity with use of 0.25% timolol gel

You may not qualify if:

• Age less than 18 years of age
• Open surgical wound \>1.5cm
• Pregnant women
• Use of systemic retinoids within 1 month
• Any hypersensitivity with use of 0.25% timolol gel

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Mohs and Dermatologic Surgery Center, Brigham and Women's Hospital

Boston, Massachusetts, 02130, United States

Location

Related Publications (9)

• Braun LR, Lamel SA, Richmond NA, Kirsner RS. Topical timolol for recalcitrant wounds. JAMA Dermatol. 2013 Dec;149(12):1400-2. doi: 10.1001/jamadermatol.2013.7135. No abstract available.

  PMID: 24172892 BACKGROUND

• Ali A, Herndon DN, Mamachen A, Hasan S, Andersen CR, Grogans RJ, Brewer JL, Lee JO, Heffernan J, Suman OE, Finnerty CC. Propranolol attenuates hemorrhage and accelerates wound healing in severely burned adults. Crit Care. 2015 May 4;19(1):217. doi: 10.1186/s13054-015-0913-x.

  PMID: 25936635 BACKGROUND

• Vestita M, Bonamonte D, Filoni A. Topical propranolol for a chronic recalcitrant wound. Dermatol Ther. 2016 May;29(3):148-9. doi: 10.1111/dth.12328. Epub 2016 Jan 22. No abstract available.

  PMID: 26800510 BACKGROUND

• Yesiloglu N, Yildiz K, Cem Akpinar A, Gorgulu T, Sirinoglu H, Ozcan A. Histogram Planimetry Method for the Measurement of Irregular Wounds. Wounds. 2016 Sep;28(9):328-333.

  PMID: 27701128 BACKGROUND

• Thomas B, Kurien JS, Jose T, Ulahannan SE, Varghese SA. Topical timolol promotes healing of chronic leg ulcer. J Vasc Surg Venous Lymphat Disord. 2017 Nov;5(6):844-850. doi: 10.1016/j.jvsv.2017.04.019. Epub 2017 Aug 7.

  PMID: 29037357 BACKGROUND

• Manahan MN, Peters P, Scuderi S, Surjana D, Beardmore GL. Topical timolol for a chronic ulcer--a case with its own control. Med J Aust. 2014 Jan 20;200(1):49-50. doi: 10.5694/mja13.10823. No abstract available.

  PMID: 24438420 BACKGROUND

• Lev-Tov H, Dahle S, Moss J, Isseroff RR. Successful treatment of a chronic venous leg ulcer using a topical beta-blocker. J Am Acad Dermatol. 2013 Oct;69(4):e204-5. doi: 10.1016/j.jaad.2013.06.003. No abstract available.

  PMID: 24034405 BACKGROUND

• Tang JC, Dosal J, Kirsner RS. Topical timolol for a refractory wound. Dermatol Surg. 2012 Jan;38(1):135-8. doi: 10.1111/j.1524-4725.2011.02200.x. Epub 2011 Oct 31. No abstract available.

  PMID: 22093053 BACKGROUND

• Zheng Z, Liu Y, Yang Y, Tang J, Cheng B. Topical 1% propranolol cream promotes cutaneous wound healing in spontaneously diabetic mice. Wound Repair Regen. 2017 May;25(3):389-397. doi: 10.1111/wrr.12546. Epub 2017 May 26.

  PMID: 28494521 BACKGROUND

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Chrysalyne D Schmults, MD, MSCE

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded physician will assess outcomes from pictures
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Mohs and Dermatologic Surgery Center

Model Details: The protocol will begin post-surgery. Eligible subjects will be assigned by computer-based randomization to case (0.25% timolol gel) or control (standard of care \[SOC\]) group and treated as follows: Case group: 1. Timolol 0.25% gel will be applied to wound bed immediately after surgery before dressing is applied 2. Starting the day after surgery: each day, the patient will cleanse the surgical site, apply 0.25% topical timolol gel (1 drop = 0.1ml for each cm2 of wound area), and re-cover wound with clean dressing 3. Daily routine continues for 12 weeks' post-surgery (even if the surgical defect has completely healed) SOC group: 1. Vaseline will be applied to wound bed immediately after surgery before dressing is applied 2. Starting the day after surgery: each day, the patient will cleanse the surgical site, apply Vaseline, and re-cover wound with clean dressing 3. This daily routine continues for 12 weeks' post-surgery (even if the surgical defect has completely healed)

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: March 2, 2018
• Study Start: August 20, 2018
• Primary Completion: December 29, 2020
• Study Completion: June 30, 2021
• Last Updated: January 12, 2022

Record last verified: 2022-01

Locations

US (1)