Efficacy and Safety of 0.25% Timolol Gel in Enhancing Full Thickness Skin Grafts Healing and Cosmetic Outcomes

NCT03579160 | Terminated Phase 2 FDA Drug

• 1 other identifier: BWHMDSC003
• Study Type: interventional
• Target: 10
• 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 82 patients who have their skin cancer surgically removed resulting in the need of a full-thickness skin graft. The objective of this randomized safety study is to determine the safety and efficacy of 0.25% timolol in promoting wound healing in full-thickness skin grafts compared to standard of care.

Conditions

Wound of Skin; Wound Heal; Surgical Wound; Full Thickness Skin Graft Healing

Outcome Measures

Primary Outcomes (1)

• Evaluating the need for further scar revision (via dermabrasion or pulsed dye laser (PDL))

  A study physician will review the healed scar site to determine if there are potential cosmetic factors that could be improved through scar revision. If the patient is interested in having scar revision procedures, the study physician will offer a dermabrasion or PDL to treat the scar site.

  6-months' post-surgery

Secondary Outcomes (7)

• Evaluating cosmetic outcomes of the receiving site of a FTSG via Vancouver Scar Scale (VSS)

  3 months' post-surgery and 6 months' post-surgery

• Evaluating cosmetic outcomes of the receiving site of a FTSG via patient Visual Analogue Scale (VAS)

  3 months' post-surgery and 6 months' post-surgery

• Evaluating change in healing response to treatment with 0.25% topical timolol gel versus SOC in terms of wound surface area at the receiving site of a FTSG via Graft Take Score

  7 days post-surgery, and 14 days post-surgery

• Evaluating change in healing response to treatment with 0.25% topical timolol gel versus SOC in terms of wound surface area at the receiving site of a FTSG via histogram planimetry

  7 days post-surgery, and 14 days post-surgery

• Evaluating change in patient discomfort during the healing process by means of a patient pain VAS

  7 days' post-surgery, 14 days' post-surgery, 30 days' post-surgery, 3 months' post-surgery, 6 months' post-surgery

Study Arms (2)

0.25% Timolol gel applied to full-thickness skin graft

EXPERIMENTAL

1. During surgery: application of 0.25% timolol gel (2 drops per cm2) on wound bed before FTSG is placed 2. During surgery: application of 0.25% timolol gel (2 drops per cm2) over FTSG after insetting of the graft 3. After bolster removal (7 days): daily cleansing and daily 0.25% timolol (2 drops per cm2) application for 4 weeks

Drug: 0.25% timolol gel with full-thickness skin grafts

Standard of Care dressings

ACTIVE COMPARATOR

1. FTSG surgery as per SOC 2. After bolster removal (7 days): daily cleansing and daily Vaseline application for 4 weeks

Other: Vaseline dressing

Interventions

0.25% timolol gel with full-thickness skin grafts DRUG

Timolol 0.25% gel will be applied to wound bed immediately after surgery before dressing is applied.

0.25% Timolol gel applied to full-thickness skin graft

Vaseline dressing OTHER

Vaseline will be applied to wound bed immediately after surgery before dressing is applied.

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 ≥18 years of age
• Undergoing a procedure which results in the need of a FTSG
• Willing to provide written informed consent

You may not qualify if:

• Age less than 18 years of age
• Pregnant women
• (Use of systemic drugs that can impede wound healing, such retinoids or immune-suppressive drugs)
• Severe coagulation disorders
• Severe, uncontrolled systemic comorbidities, such as diabetes, arthritis, etc.
• Hypersensitivity to 0.25% timolol gel
• Not willing to provide written informed consent

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

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

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: Receiving site of FTSG/case group: 1. During surgery: application of 0.25% timolol gel (2 drops per cm2) on wound bed before FTSG is placed 2. During surgery: application of 0.25% timolol gel (2 drops per cm2) over FTSG after insetting of the graft 3. After bolster removal (7 days): daily cleansing and daily 0.25% timolol (2 drops per cm2) application for 4 weeks Receiving site of FTSG/control group: 1. FTSG surgery as per SOC 2. After bolster removal (7 days): daily cleansing and daily Vaseline application for 4 weeks

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: July 6, 2018
• Study Start: January 2, 2019
• Primary Completion: January 10, 2022
• Study Completion: January 10, 2022
• Last Updated: January 25, 2022

Record last verified: 2022-01

Locations

US (1)