Efficacy and Safety of Topical Timolol in Secondary Intention Surgical Wounds Healing
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis
About this trial
The purpose of this research study is to evaluate the efficacy and safety of topical timolol 0.5% for secondary intention wound healing following 1) Mohs micrographic surgery, 2) standard surgical excision, OR 3) electrodesiccation and curettage (ED\&C). Please note that healing by secondary intention refers to when a wound heals naturally without surgical closure.
To evaluate the efficacy of topical timolol 0.5%, 220 participants will be recruited. Participants will be placed into one of two groups: The treatment group or the control group.
1. The treatment group will receive a topical timolol 0.5% solution, which will be applied to their wound daily for 12 weeks. 2. The control group will receive standard care with the addition of hydrogel, which will also be applied to their wound daily for 12 weeks.
During this 12-week period, both groups will be required to upload photos of their wound healing to their MyChart account at weeks 3, 6, 9, and 12. These photos will be reviewed by the investigator to assess wound healing. Re-epithelialization and earlier complete wound healing will be compared between both groups to determine the efficacy of topical timolol 0.5% solution compared to the standard of care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female subject of any race 18 years old or older
Patient opt to heal by secondary intention healing after discussion of reconstructive options following excision
Patients undergoing Mohs micrographic surgery, standard surgical excision, or electrodesiccation and curettage (ED&C) whose wounds are managed by secondary intention healing.
Willing to send photos of ulcer at 3 week intervals with ruler measuring length by width
Disqualifiers
Cyst excisions (due to concern for inflammation)
Site shows evidence of infection (defined as a moderate or severe rating of all of the following clinical signs/symptoms: 1) increased warmth, 2) increased pain, 3) erythema, and 4) malodorous exudate at Screening or at Randomization (Visit 1), OR total organism count > 1 x 105 colony forming units (CFU) from the screening visit study ulcer culture sample)
Severe COPD/asthma/cardiac arrhythmia
Hx of documented beta blocker allergy
Trial design
Design model
Parallel
Treatments tested in this trial
Timolol 0.5% Ophthalmic Solution
DrugTopical Timolol 0.5% solution will be applied to patients wounds in 2 cm intervals along the widest diameter of the wound daily for 12 weeks following their medical procedure.
Hydrogel of placebo
Other interventionHydrogel will be placed on the wound at 2 cm intervals along the widest diameter of the wound daily for 12 weeks following the patient's medical procedure.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: TimololExperimental treatment 1 intervention
Group B: HydrogelPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Area of Surgical Ulcer
The percent change in the area of surgical ulcers in patients using the study medication (treatment group) will be compared to those receiving standard care (placebo group).
Time frame
Baseline, week 3, week 6, week 9 and week 12Secondary outcomes
1
Infection Rate
The number of patients who develop infections during treatment in both the treatment and placebo groups.
Time frame
Baseline to Week 122
Risk Factor for Poor Wound Healing
Sub-group analysis in patients with risk factors for poor wound healing; diabetes, smoking, cardiovascular disease, peripheral vascular disease, venous insufficiency, and/or long term prednisone use.
Time frame
Baseline to Week 123
Type of Wounds
Subgroup analyses will be performed by wound type (Mohs surgery, excision, ED\&C) to assess for differential treatment effects.
Time frame
Baseline to Week 124
Incidences of Hypotension
Incidence of clinically significant hypotension (requiring medical attention) in patients treated with timolol
Time frame
Baseline to Week 12Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: