Cutaneous Leishmaniasis
Conditions
Keywords
cutaneous leishmaniasis, topical treatment, Tunisia
Brief summary
This study will test the ability of the topical cream WR 279,396 to treat the skin lesions caused by the parasite called leishmania. WR 279,396 is an antibiotic preparation that contains paromomycin + gentamicin. This cream will be compared to the effect of a topical cream containing paromomycin alone and to a placebo cream that contains no antibiotics. Therefore, this study will have three groups of patients, and they will be assigned to one of these treatments randomly. The study will be carried out without the patient or the physician knowing which cream is being used for which patient. The goal is to determine if WR 279,396 cream or the paromomycin cream is better than placebo, and if WR 279,396 is better than paromomycin alone.
Detailed description
This is an efficacy study to test the ability of WR 279,396 topical cream to treat uncomplicated cutaneous leishmaniasis caused primarily by Leishmania major in adults and children in Tunisia where the disease in endemic. A total of 375 volunteers will be randomized to the three arms described above to determine product efficacy. Safety data in all three arms will also be collected.
Interventions
WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
DRUGParomomycin Alone topical cream
The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
DRUGVehicle placebo cream
Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
Sponsors
U.S. Army Medical Research and Development Command
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* The subject was age 5 years or older, but less than 65 years. * The subject was able to understand the information provided to him/her and give written informed consent. Consent was obtained from the parent/guardian of subjects who were \< 18 years old. Children 12 to \< 18 years old were asked to sign the written assent form. Witnessed verbal assent was obtained from subjects 5 to 11 years old. * The subject was a male or female who was generally healthy. * The subject had cutaneous lesions diagnosed as leishmaniasis in the index lesion by: (1) the identification of promastigotes in a culture of an aspirated lesion, or (2) the microscopic identification of Leishmania amastigotes on a DifQuik or Giemsa stained smear obtained from a lesion scraping. * The subject had five or fewer cutaneous lesions. * The subject had one lesion, which would be designated as the index lesion, that was ≥ 1 and \< 5 cm in its greatest diameter and primarily ulcerative, ie, not purely verrucous or nodular. * The subject was willing to forego other forms of treatment for CL, including other investigational treatment during the study. * In the opinion of the principal investigator, the subject or subject's parent/guardian was capable of understanding and complying with the protocol
Exclusion criteria
* The subject received previous treatment for leishmaniasis (including WR 279,396) within the last 6-months, with the exception of mercurochrome. * The subject had difficulty complying with instructions on maintaining the dressing, eg, due to life style activities or age. * The subject had only a single lesion whose characteristics included any of the following: verrucous or nodular lesion, ≥ 5 cm in its greatest diameter, \< 1 cm or located on the ear, or other location that in the opinion of the principal investigator would be difficult to maintain application of study drug topically. * The subject had a lesion due to Leishmania that involved the mucosa. * The subject had signs or symptoms of disseminated disease, ie, clinically significant lymphadenitis with nodules that were painful and \> 1 cm in the lymphatic drainage of the ulcer. * The subject was a female with a positive urine pregnancy test, or who was breast feeding or lactating. * The subject had an active malignancy or had a history of a solid, metastatic or hematologic malignancy, with the exception of a basal or squamous cell carcinoma of the skin that had been removed. * The subject had a significant organ abnormality or chronic disease that, in the opinion of the investigator, would warrant exclusion of the subject from the study or would prevent the subject from completing the study. * The subject was receiving any of the following medications: any medication containing pentavalent antimony, including stibogluconate sodium (Pentostam®) and meglumine antimoniate (Glucantime®); amphotericin B, including liposomal amphotericin B and amphotericin B deoxycholate; other medications containing paromomycin (administered IV or topically); methylbenzethonium chloride, fluconazole, ketoconazole, itraconazole; pentamidine; or allopurinol. * The subject or the subject's parent/guardian was unable to understand verbal and/or written Arabic, English, or French (languages in which certified translations of the informed consent were available). * The subject presented with an immuno-compromising condition, including recidivant leishmaniasis (during the past 2 years), or diabetes. * The subject had a history of known or suspected idiosyncratic reactions or hypersensitivity to aminoglycosides.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Final Clinical Cure Rate | Day 42, 98, and 168 | Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes were as follows: * Initial Clinical Improvement: At least 50% to 99% reduction in the size of the measured lesion from the baseline measurement by the Day 42 evaluation. * Initial Clinical Cure: 100% re-epithelialization (ie, a 0 x 0 length x width measurement) of the lesion at the nominal Day 42 evaluation, or initial clinical improvement followed by 100% re-epithelialization by Day 98. * Relapse: Initial clinical cure followed by re-ulceration by Day 168, or initial clinical improvement followed by lesion enlargement by Day 168. * Final Clinical Cure: Initial clinical cure without relapse through study Day 168.Clinical Failure: Lack of at least initial clinical improvement by Day 42, or relapse. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Percentage Subjects With Re-epithelialization of the Index Lesion Without Relapse | Day 42 | For the first of the above analyses, subjects were considered to have endpoint events at the first assessment on or before Day 42 where complete re-epithelialization occurred at the index lesion that was not followed by a later assessment where ulceration was present. Subjects who did not have complete re-epithelialization by Day 42 or who relapsed after Day 42 were censored in the analysis at the Day 42 assessment. This analysis was only to be conducted through Day 42. |
| Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up | Days 42, 49, and 98 | — |
| Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 42 | Days 42 | — |
| Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 49 | Days 49 | — |
| Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 98 | Days 98 | — |
| Final Clinical Cure Rate (Per Protocol Dataset) | Day 42, 98, and 168 | Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes as described in the primary outcome measure. |
| Number of Subjects Achieving Re-epithelialization of the Index Lesion Without Relapse | Day 168 | Number of Subjects Achieving Re-epithelialization of the Index Lesion by Day 42 without Relapse from Day 42 Onward, Imputing Relapse for any Subject with a Missing Visit after Day 42 |
| Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions Without Subsequent Relapse | Day 168 | Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions at Day 42 without Subsequent Relapse from Day 42 Onward, |
| Number of All Ulcerated Lesions Achieving 100% Re-epithelialization by Day 42 | Day 42 | — |
| Number of Subjects With a Relapse on or After Day 42 | Day 168 | — |
| Number of Subjects Achieving Initial Clinical Improvement of the Index Lesion | Day 42 | — |
Countries
Tunisia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| WR 279,396 Topical Treament WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing. | 125 |
| Paromomycin Alone Topical Treatment Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing. | 125 |
| Vehicle Placebo Cream The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing. | 125 |
| Total | 375 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Clinical failures | 1 | 0 | 12 |
| Overall Study | Lost to Follow-up | 1 | 1 | 4 |
| Overall Study | Withdrawal by investigator | 0 | 1 | 6 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | WR 279,396 Topical Treament | Paromomycin Alone Topical Treatment | Vehicle Placebo Cream | Total |
|---|---|---|---|---|
| Age, Continuous | 23.4 years STANDARD_DEVIATION 15.9 | 24.6 years STANDARD_DEVIATION 15.7 | 23.2 years STANDARD_DEVIATION 15.2 | 23.7 years STANDARD_DEVIATION 15.6 |
| Age, Customized Adults | 63 participants | 66 participants | 61 participants | 190 participants |
| Age, Customized Children (12 to 17) | 24 participants | 33 participants | 35 participants | 92 participants |
| Age, Customized Children (5 to 11) | 38 participants | 26 participants | 29 participants | 93 participants |
| All lesion characteristics Flat-like | 0 lesions | 1 lesions | 0 lesions | 1 lesions |
| All lesion characteristics Nodule | 0 lesions | 1 lesions | 0 lesions | 1 lesions |
| All lesion characteristics Number of | 243 lesions | 272 lesions | 282 lesions | 797 lesions |
| All lesion characteristics Other | 3 lesions | 7 lesions | 3 lesions | 13 lesions |
| All lesion characteristics Papule | 0 lesions | 1 lesions | 0 lesions | 1 lesions |
| All lesion characteristics Ulcerative | 240 lesions | 262 lesions | 279 lesions | 781 lesions |
| All lesion ulceration area | 86.8 mm^2 STANDARD_DEVIATION 107 | 65.6 mm^2 STANDARD_DEVIATION 91.1 | 70.3 mm^2 STANDARD_DEVIATION 91.4 | 73.8 mm^2 STANDARD_DEVIATION 96.5 |
| All ulcerated lesions Area of ulceration ≤ 100 m^2 | 175 lesions | 210 lesions | 222 lesions | 607 lesions |
| All ulcerated lesions Area of ulceration > 100 mm^2 | 65 lesions | 52 lesions | 57 lesions | 174 lesions |
| Days before treatment that index lesion was first noticed | 39.3 days STANDARD_DEVIATION 25.7 | 39.5 days STANDARD_DEVIATION 20 | 38.9 days STANDARD_DEVIATION 20.5 | 39.2 days STANDARD_DEVIATION 22.2 |
| Days before treatment that index lesion was first noticed (categorical) ≤ 60 days | 110 participants | 109 participants | 109 participants | 328 participants |
| Days before treatment that index lesion was first noticed (categorical) > 60 days | 15 participants | 16 participants | 16 participants | 47 participants |
| Index lesion Area of ulceration ≤ 100 m^2 | 72 participants | 84 participants | 89 participants | 245 participants |
| Index lesion Area of ulceration > 100 mm^2 | 53 participants | 41 participants | 36 participants | 130 participants |
| Index lesion ulceration area | 126 mm^2 STANDARD_DEVIATION 121 | 90.2 mm^2 STANDARD_DEVIATION 74.5 | 97.7 mm^2 STANDARD_DEVIATION 112 | 105 mm^2 STANDARD_DEVIATION 105 |
| Race/Ethnicity, Customized North African | 125 participants | 125 participants | 125 participants | 375 participants |
| Sex: Female, Male Female | 69 Participants | 57 Participants | 56 Participants | 182 Participants |
| Sex: Female, Male Male | 56 Participants | 68 Participants | 69 Participants | 193 Participants |
| Total Number of lesions per subject 1 lesion | 59 participants | 49 participants | 50 participants | 158 participants |
| Total Number of lesions per subject More than 1 lesions | 66 participants | 76 participants | 75 participants | 217 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 55 / 125 | 51 / 125 | 45 / 125 |
| serious Total, serious adverse events | 0 / 125 | 0 / 125 | 0 / 125 |
Outcome results
Primary
Final Clinical Cure Rate
Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes were as follows: * Initial Clinical Improvement: At least 50% to 99% reduction in the size of the measured lesion from the baseline measurement by the Day 42 evaluation. * Initial Clinical Cure: 100% re-epithelialization (ie, a 0 x 0 length x width measurement) of the lesion at the nominal Day 42 evaluation, or initial clinical improvement followed by 100% re-epithelialization by Day 98. * Relapse: Initial clinical cure followed by re-ulceration by Day 168, or initial clinical improvement followed by lesion enlargement by Day 168. * Final Clinical Cure: Initial clinical cure without relapse through study Day 168.Clinical Failure: Lack of at least initial clinical improvement by Day 42, or relapse.
Time frame: Day 42, 98, and 168
Population: Modified intention-to-treat (mITT) - all subjects randomized who received at least one treatment of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WR 279,396 Topical Treament | Final Clinical Cure Rate | 101 participants |
| Paromomycin Alone Topical Treatment | Final Clinical Cure Rate | 102 participants |
| Vehicle Placebo Cream | Final Clinical Cure Rate | 73 participants |
Comparison: H01: There is no difference in the final clinical cure rate between WR 279,396 and Vehicle AND there is no difference in the final clinical cure rate between Paromomycin Alone and Vehicle.p-value: 0.0001Chi-squared
Comparison: H01: There is no difference in the final clinical cure rate between WR 279,396 and Vehicle AND there is no difference in the final clinical cure rate between Paromomycin Alone and Vehicle.p-value: <0.0001Chi-squared
Comparison: H02: There is no difference in clinical cure between WR 279,396 and Paromomycin Alone. Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.p-value: 0.871Chi-squared
Secondary
Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 42
Time frame: Days 42
Population: mITT dataset
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WR 279,396 Topical Treament | Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 42 | 51.7 Percentage of lesions |
| Paromomycin Alone Topical Treatment | Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 42 | 81.6 Percentage of lesions |
| Vehicle Placebo Cream | Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 42 | 58.1 Percentage of lesions |
Secondary
Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 49
Time frame: Days 49
Population: mITT dataset
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WR 279,396 Topical Treament | Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 49 | 81.4 percentage of lesions |
| Paromomycin Alone Topical Treatment | Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 49 | 90.4 percentage of lesions |
| Vehicle Placebo Cream | Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 49 | 64.9 percentage of lesions |
Secondary
Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 98
Time frame: Days 98
Population: mITT dataset
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WR 279,396 Topical Treament | Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 98 | 91.5 percentage of lesions |
| Paromomycin Alone Topical Treatment | Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 98 | 98.9 percentage of lesions |
| Vehicle Placebo Cream | Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 98 | 92.2 percentage of lesions |
Secondary
Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up
Time frame: Days 42, 49, and 98
Population: mITT dataset. The data show that 95.8% of the Vehicle-treated subjects remaining in the study at Day 168 (the percentage excludes the 17.6% of subjects who dropped out or were withdrawn early due to treatment failure) had re-epithelialization of the index lesion.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| WR 279,396 Topical Treament | Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up | Day 49 | 72.9 percentage of participants |
| WR 279,396 Topical Treament | Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up | Day 42 | 67.2 percentage of participants |
| WR 279,396 Topical Treament | Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up | Day 98 | 94.3 percentage of participants |
| Paromomycin Alone Topical Treatment | Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up | Day 49 | 81.5 percentage of participants |
| Paromomycin Alone Topical Treatment | Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up | Day 42 | 68.5 percentage of participants |
| Paromomycin Alone Topical Treatment | Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up | Day 98 | 99.2 percentage of participants |
| Vehicle Placebo Cream | Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up | Day 42 | 49.4 percentage of participants |
| Vehicle Placebo Cream | Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up | Day 98 | 90.9 percentage of participants |
| Vehicle Placebo Cream | Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up | Day 49 | 57.1 percentage of participants |
Secondary
Estimated Percentage Subjects With Re-epithelialization of the Index Lesion Without Relapse
For the first of the above analyses, subjects were considered to have endpoint events at the first assessment on or before Day 42 where complete re-epithelialization occurred at the index lesion that was not followed by a later assessment where ulceration was present. Subjects who did not have complete re-epithelialization by Day 42 or who relapsed after Day 42 were censored in the analysis at the Day 42 assessment. This analysis was only to be conducted through Day 42.
Time frame: Day 42
Population: mITT dataset
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WR 279,396 Topical Treament | Estimated Percentage Subjects With Re-epithelialization of the Index Lesion Without Relapse | 67.2 percentage of participants |
| Paromomycin Alone Topical Treatment | Estimated Percentage Subjects With Re-epithelialization of the Index Lesion Without Relapse | 68.8 percentage of participants |
| Vehicle Placebo Cream | Estimated Percentage Subjects With Re-epithelialization of the Index Lesion Without Relapse | 48.8 percentage of participants |
p-value: 0.33Log Rank
p-value: 0.275Log Rank
p-value: 0.83Log Rank
Secondary
Final Clinical Cure Rate (Per Protocol Dataset)
Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes as described in the primary outcome measure.
Time frame: Day 42, 98, and 168
Population: Per protocol - all randomized subjects who received at least one treatment of study drug and whose outcomes at Day 42, Day 98 (if applicable) and Day 168 could be assessed. However, a subject was still considered per-protocol if withdrawn early for treatment failure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WR 279,396 Topical Treament | Final Clinical Cure Rate (Per Protocol Dataset) | 101 participants |
| Paromomycin Alone Topical Treatment | Final Clinical Cure Rate (Per Protocol Dataset) | 102 participants |
| Vehicle Placebo Cream | Final Clinical Cure Rate (Per Protocol Dataset) | 73 participants |
p-value: 0.0006Chi-squared
p-value: 0.0002Chi-squared
p-value: 0.767Chi-squared
Secondary
Number of All Ulcerated Lesions Achieving 100% Re-epithelialization by Day 42
Time frame: Day 42
Population: mITT dataset
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WR 279,396 Topical Treament | Number of All Ulcerated Lesions Achieving 100% Re-epithelialization by Day 42 | 190 Ulcerated lesions |
| Paromomycin Alone Topical Treatment | Number of All Ulcerated Lesions Achieving 100% Re-epithelialization by Day 42 | 218 Ulcerated lesions |
| Vehicle Placebo Cream | Number of All Ulcerated Lesions Achieving 100% Re-epithelialization by Day 42 | 160 Ulcerated lesions |
p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
p-value: 0.247Chi-squared
Secondary
Number of Subjects Achieving Initial Clinical Improvement of the Index Lesion
Time frame: Day 42
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WR 279,396 Topical Treament | Number of Subjects Achieving Initial Clinical Improvement of the Index Lesion | 105 participants |
| Paromomycin Alone Topical Treatment | Number of Subjects Achieving Initial Clinical Improvement of the Index Lesion | 107 participants |
| Vehicle Placebo Cream | Number of Subjects Achieving Initial Clinical Improvement of the Index Lesion | 77 participants |
p-value: 0.0001Chi-squared
p-value: <0.0001Chi-squared
p-value: 0.725Chi-squared
Secondary
Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions Without Subsequent Relapse
Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions at Day 42 without Subsequent Relapse from Day 42 Onward,
Time frame: Day 168
Population: mITT dataset
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WR 279,396 Topical Treament | Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions Without Subsequent Relapse | 83 participants |
| Paromomycin Alone Topical Treatment | Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions Without Subsequent Relapse | 84 participants |
| Vehicle Placebo Cream | Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions Without Subsequent Relapse | 60 participants |
p-value: 0.003Chi-squared
p-value: 0.002Chi-squared
p-value: 0.893Chi-squared
Secondary
Number of Subjects Achieving Re-epithelialization of the Index Lesion Without Relapse
Number of Subjects Achieving Re-epithelialization of the Index Lesion by Day 42 without Relapse from Day 42 Onward, Imputing Relapse for any Subject with a Missing Visit after Day 42
Time frame: Day 168
Population: mITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WR 279,396 Topical Treament | Number of Subjects Achieving Re-epithelialization of the Index Lesion Without Relapse | 84 participants |
| Paromomycin Alone Topical Treatment | Number of Subjects Achieving Re-epithelialization of the Index Lesion Without Relapse | 84 participants |
| Vehicle Placebo Cream | Number of Subjects Achieving Re-epithelialization of the Index Lesion Without Relapse | 62 participants |
p-value: 0.005Chi-squared
p-value: 0.005Chi-squared
p-value: 1Chi-squared
Secondary
Number of Subjects With a Relapse on or After Day 42
Time frame: Day 168
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WR 279,396 Topical Treament | Number of Subjects With a Relapse on or After Day 42 | 4 participants |
| Paromomycin Alone Topical Treatment | Number of Subjects With a Relapse on or After Day 42 | 3 participants |
| Vehicle Placebo Cream | Number of Subjects With a Relapse on or After Day 42 | 2 participants |
p-value: 0.409Chi-squared
p-value: 0.651Chi-squared
p-value: 0.701Chi-squared