Efficacy and Safety of Product S2G6T-1in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis

• Sponsor: Sol-Gel Technologies, Ltd. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02842021
• Collaborator: (none)
• Enrollment: 283
• Locations: 19
• Arms: 4
• Duration (Months): 13
• Patients Per Site: 14.9
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

To assess the efficacy and safety of a combination product S2G6T-1 compared to its monads and vehicle, applied twice daily for 7 days, in the treatment of symptomatic inflammatory interdigital tinea pedis in subjects 12 years of age and older. The results of this study will be utilized to perform power calculations for the Phase 3 pivotal trials.

Condition or Disease	Intervention/Treatment	Phase
Tinea Pedis	Drug: S2G6T-1; Drug: S2G6T-2; Drug: S2G6T-3; Drug: S2G6T-4	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 283 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Active- and Vehicle-Controlled Study to Compare the Efficacy and Safety of Products S2G6T-1, S2G6T-2, S2G6T-3 and S2G6T-4 in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis
• Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Oct 1, 2017
• Actual Study Completion Date: Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: S2G6T-1 Topical cream	Drug: S2G6T-1; Twice a day topical cream
Active Comparator: S2G6T-2 Topical Cream	Drug: S2G6T-2; Twice a day topical cream
Active Comparator: S2G6T-3 Topical Cream	Drug: S2G6T-3; Twice a day topical cream
Placebo Comparator: S2G6T-4 Topical Cream	Drug: S2G6T-4; Twice a day topical cream

Outcome Measures

Primary Outcome Measures

1. Complete cure at Day 29 [Day 29]

   The primary efficacy comparison between S2G6T-1 vs. rest of study arms will be based on the percentage of subjects at day 29 with complete cure of interdigital tinea pedis.mycological cure (i.e. negative dermatophyte culture and negative KOH) and clinical cure (i.e. absence of erythema, scaling and pruritus {scores of 0, each})

2. Reduction in Tinea pedis SymptomS through treatment period. [Day 8]

   comparison of Patient Assessment between S2G6T-1 vs. rest of study arms will be based on the percentage of subjects at day 8 with achieving decrease from baseline in the total score for pruritus and burning.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Ability and willingness to sign a written informed consent and /or assent (age appropriate).

2. Male or Female subjects 12 years of age or older.

3. A clinical diagnosis of interdigital tinea pedis on one or both feet characterized by clinical evidence of a tinea infection.

4. A sum of at least five (5) for signs (erythema and scaling) by the investigator on the selected target foot, and a score of at least five (5) for each symptom: pruritus (itching) and burning: and a sum of at least twelve (12) for both symptoms (pruritus and burning) by the subject on the PATSS.

5. Mycological evidence of the presence of fungi confirmed by the detection of fungal hyphae on a microscopic KOH wet mount.

6. Females of child-bearing potential must have a negative urine pregnancy test and must agree to use an effective form of contraception during the study .

7. Must be in good general health as determined by medical history and free of any disease that in the investigator's opinion might interfere with the study evaluations.

8. Must be able to communicate, be able to understand the study procedures, and be willing to comply with the study requirements.

Exclusion Criteria:

1. The presence of confluent diffuse moccasin-type tinea pedis.

2. Negative KOH microscopy test to assess presence of hyphae.

3. Onychomycosis of the toenails, involving ≥ 20% of the area of either great toenail or involvement of more than five toenails in total.

4. Concurrent tinea infection or bacterial skin infection on the feet.

5. Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial.

6. Recent history of or currently known to abuse drugs or alcohol.

7. History of intolerance or hypersensitivity to Econazole Nitrate, Mometasone Furoate, or other imidazole agents.

8. Presence of any other infection of the foot or other disease process that might confound the treatment evaluation.

9. Having a life-threatening condition or immunocompromised (e.g., autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.

10. Unable to communicate or cooperate with the investigator due to language barriers, poor mental development, or impaired cerebral function.

11. Current participation in a clinical drug research study or recent participation in a clinical trial within 30 days of Baseline.

12. Using the following medications prior to Baseline:

13. Antipruritics, including antihistamines within 3 days (72 hours).

14. Topical corticosteroids, antibiotics or antifungal therapies within 4 weeks.

15. Systemic corticosteroids, antibiotics or antifungal therapies within 12 weeks.

16. Oral terbinafine or itraconazole within 12 weeks.

17. Immunosuppressive medication or radiation therapy within 12 weeks.

18. Any other topical medicated topical treatments to the treatment area(s) within 7 days.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TCR Medical Corporation	San Diego	California	United States	92123
2	University Clinical Trials, Inc.	San Diego	California	United States	92123
3	Tampa Bay Medical Research	Clearwater	Florida	United States	33761
4	Tory Sullivan, MD, PA	North Miami Beach	Florida	United States	33162
5	Park Avenue Dermatology	Orange Park	Florida	United States	32073
6	Mid Atlantic Research for Health	Baltimore	Maryland	United States	21214
7	Minnesota Clinical Study Center	Fridley	Minnesota	United States	55432
8	Academic Dermatology Associates	Albuquerque	New Mexico	United States	87106
9	Skin Search of Rochester, Inc.	Rochester	New York	United States	146232
10	Tennessee Clinical Research Center	Nashville	Tennessee	United States	37215
11	DermResearch, Inc.	Austin	Texas	United States	78759
12	J&S Studies, Inc	College Station	Texas	United States	77845
13	Suzanne Bruce & Associates, PA / The Center for Skin Research	Houston	Texas	United States	77056
14	Suzanne Bruce & Associates ,PA / The Center for Skin Research	Katy	Texas	United States	77494
15	DermResearch New Braunfels	New Braunfels	Texas	United States	78130
16	Endeavor Clinical Trials, PA	San Antonio	Texas	United States	78229
17	Dermatology Research Center, Inc.	Salt Lake City	Utah	United States	84117
18	The Education & Research Foundation Inc.	Lynchburg	Virginia	United States	24501
19	Virginia Clinical Research Inc.	Norfolk	Virginia	United States	23502

Sponsors and Collaborators

• Sol-Gel Technologies, Ltd.

Investigators

• Study Chair: Kathleen O Ashenfelter, MS, Cu-Tech, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sol-Gel Technologies, Ltd.
• ClinicalTrials.gov Identifier: NCT02842021
• Other Study ID Numbers: SGT-26-01
• First Posted: Jul 22, 2016
• Last Update Posted: Nov 18, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Tinea; Tinea Pedis

Study Results

No Results Posted as of Nov 18, 2020