Three-Arm Trial of Novel Treatment for Tinea Pedis
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|ClinicalTrials.gov Identifier: NCT03135912|
Recruitment Status : Completed
First Posted : May 2, 2017
Last Update Posted : October 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tinea Pedis||Drug: Experimental Drug SESC 01 Drug: Placebo Drug: Terbinafine Hydrochloride||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Three-Arm Trial of Novel Treatment for Tinea Pedis|
|Actual Study Start Date :||January 3, 2017|
|Actual Primary Completion Date :||August 2, 2017|
|Actual Study Completion Date :||August 2, 2017|
Experimental: Experimental Treatment
Patients supplied with Experimental Drug SESC 01 for daily topical therapy for 4 weeks.
Drug: Experimental Drug SESC 01
Topical experimental treatment comprising a combination of approved topical therapies and a new dosage method.
Placebo Comparator: Vehicle Control
Patients supplied with inactive vehicle (placebo), identical to experimental treatment but without active ingredients, to be applied daily for 4 weeks.
Dosage method of SESC 01, without active ingredients.
Active Comparator: Active Comparator
Terbinafine hydrochloride cream, to be applied twice daily for 4 weeks.
Drug: Terbinafine Hydrochloride
Topical terbinafine hydrochloride cream.
Other Name: Lamisil AT
- Effective Treatment (Mycological Cure and Minimal Symptoms) [ Time Frame: 6 weeks ]Binary outcome measure defined as mycological cure AND a total clinical assessment score less than or equal to 2 (out of a possible 18). Mycological cure is defined as negative potassium hydroxide microscopy, while the clinical assessment is based on a sum of 6 symptoms (desquamation, vesiculation, erythema, fissuring, maceration, and pruritus) scored 0-3 by a physician.
- Rate of Adverse Events [ Time Frame: 6 weeks ]To examine treatment safety, we will calculate the rate of adverse events and serious adverse and compare them between the study's three arms using Chi-square tests to evaluate whether a statistically significant difference is present.
- Effective Treatment (Mycological Cure and Minimal Symptoms) [ Time Frame: 4 weeks ]Effective treatment as defined above, but measured at the end of treatment (4 weeks after the beginning of participation).
- Patient Satisfaction Score [ Time Frame: 4 weeks ]At the conclusion of treatment, patients complete a brief survey on their impressions of the treatment's tolerability, effectiveness, and convenience on a five-point scale, where 1 = poor, 2 = fair, 3 = good, 4 = very good, 5 = excellent, or they may answer with "No answer/prefer not to say". Scores will be compared for each of the three characteristics and as a sum of the three scores.
- Self-Reported Patient Compliance [ Time Frame: 4 weeks ]On the same experience questionnaire, patients are asked to estimate how many doses of treatment they missed or forgot to take. Possible answers are None, 1-2, 3-4, 5-6, 7-8, or 9 or more. This indicates whether there is a significant difference in patients' likelihood to adhere to a treatment regimen.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135912
|United States, Massachusetts|
|Kuchnir Dermatology & Dermatologic Surgery|
|Milford, Massachusetts, United States, 01757|
|Principal Investigator:||Carl Schanbacher, MD||South End Skin Care|