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A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis

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ClinicalTrials.gov Identifier: NCT03897257
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Therapeutics, Inc.

Brief Summary:
The study is being done to determine and compare the safety and effectiveness of an investigational combination therapy (low and high concentrations) versus mono-therapy (low and high concentrations) or mono-therapy (fixed concentration) in subjects with moccasin type tinea pedis.

Condition or disease Intervention/treatment Phase
Tinea Pedis Drug: UHE-103A1 cream Drug: UHE-103A2 cream Drug: UHE-103B cream Drug: UHE-103A1B cream Drug: UHE-103A2B cream Phase 2

Detailed Description:
UHE-103 cream is an investigational combination drug to treat moccasin type tinea pedis, a fungal infection that affects the feet and toes. Eligible subjects will be assigned to one of the 5 possible treatment groups and participate for a total of 6 weeks. Subjects will apply their assigned test drug twice daily for 2 weeks. Each subject will then be assessed for safety and efficacy at week 4 and week 6. There will be a total of 5 clinic visits: 1 screening/baseline visit (Day 1), 2 treatment visits (Days 8 and 15), and 2 follow-up visits (Days 29 and 43).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Five Arms:

  • 3 Arms of Monotherapy : UHE-103A1 cream (Drug A low dose concentration) or UHE-103A2 cream (Drug A high concentration) or UHE-103B cream (Drug B comparator)
  • 2 Arms of combination therapy: UHE-103A1B cream (Drug A low dose + Drug B), or UHE-103A2B cream (Drug A high dose + Drug B)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blinded, Parallel Group Comparison Study of the Safety and Efficacy of UHE-103 in Subjects With Moccasin-Type Tinea Pedis
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : November 29, 2019
Estimated Study Completion Date : December 27, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: UHE-103A1 cream
Topical cream applied twice daily for 2 weeks.
Drug: UHE-103A1 cream
Investigational mono-therapy cream (containing drug A [low dose])

Experimental: UHE-103A2 cream
Topical cream applied twice daily for 2 weeks.
Drug: UHE-103A2 cream
Investigational mono-therapy cream (containing drug A [low dose])

Experimental: UHE-103B cream
Topical cream applied twice daily for 2 weeks.
Drug: UHE-103B cream
Comparator mono-therapy cream (containing drug B)

Experimental: UHE-103A1B cream
Topical cream applied twice daily for 2 weeks.
Drug: UHE-103A1B cream
Investigational combination-therapy cream (containing drug A [low dose] + drug B)

Experimental: UHE-103A2B cream
Topical cream applied twice daily for 2 weeks.
Drug: UHE-103A2B cream
Investigational combination-therapy cream (containing drug A [high dose] + drug B)




Primary Outcome Measures :
  1. Complete Cure at End of Study [ Time Frame: Day 43 ]
    Proportion of subjects with Complete Cure (negative fungal test & no clinical disease-induced signs and symptoms) at end of study (EOS).


Secondary Outcome Measures :
  1. Effective treatment [ Time Frame: Day 43 ]
    Proportion of subjects with Effective Treatment (negative fungal test & no to mild clinical disease-induced signs and symptoms) at EOS.

  2. Mycological Cure [ Time Frame: Day 43 ]
    Proportion of subjects with Mycological Cure (negative fungal test) at EOS.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or non-pregnant female, 16 years of age or older.
  • Clinical diagnosis of moccasin type tinea pedis
  • Microscopic evidence (positive KOH) of the presence of fungi
  • Provided written informed consent/assent
  • In general good health

Exclusion Criteria:

  • Pregnant or lactating or planning to get pregnant while on the study
  • Has concurrent tinea infection (e.g., tinea versicolor, tinea cruris)
  • Other skin disease which might interfere with the evaluation of tinea pedis
  • History of diabetes mellitus or is immunocompromised
  • Currently enrolled in an investigational drug or device study
  • Used an investigational drug or investigational device treatment within 30 days prior to Visit 1 (Study Day 1)/Baseline

Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.


Information from the National Library of Medicine

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): NCT03897257


Contacts
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Contact: TI Clinical Research 1-858-571-1800 ext 147 clinicalresearch@therapeuticsinc.com

Locations
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United States, California
Site 03 Recruiting
San Diego, California, United States, 92123
Contact    858-571-6800      
United States, Florida
Site 12 Recruiting
Melbourne, Florida, United States, 32935
Contact    321-253-6191      
Site 06 Recruiting
Miami, Florida, United States, 33144
Contact    305-225-0400      
Site 09 Recruiting
North Miami Beach, Florida, United States, 33162
Contact    305-652-8600      
United States, Illinois
Site 07 Recruiting
Rolling Meadows, Illinois, United States, 60008
Contact    847-392-5440      
United States, Minnesota
Site 11 Recruiting
Fridley, Minnesota, United States, 55432
Contact    763-571-4200      
United States, New York
Site 04 Recruiting
Rochester, New York, United States, 14623
Contact    585-697-1818      
United States, Texas
Site 01 Recruiting
Austin, Texas, United States, 78759
Contact    512-349-9889      
Site 02 Recruiting
Houston, Texas, United States, 77055
Contact    281-738-2642      
Site 10 Recruiting
San Antonio, Texas, United States, 78229
Contact    210-949-0807      
United States, Virginia
Site 05 Recruiting
Norfolk, Virginia, United States, 23502
Contact    757-625-0151      
Puerto Rico
Site 08 Recruiting
Cidra, Puerto Rico, 00739
Contact    787-739-3376      
Sponsors and Collaborators
Therapeutics, Inc.
Investigators
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Principal Investigator: Marietta Radona, MD Therapeutics, Inc.

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Responsible Party: Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03897257     History of Changes
Other Study ID Numbers: 146-9252-201
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms