Tinea Versicolor
Conditions
Brief summary
A Randomized, Double-Blinded, Aqueous Gel-Controlled Dose Escalating Trial to Study the Safety and Antimicrobial Efficacy of DBI-002 Probiotic vs. Aqueous Gel and Vehicle Gel vs. Aqueous Gel in Adults with Tinea Versicolor (DBI-202).
Detailed description
All subjects are required to have a clinical diagnosis of Tinea Versicolor on their chest and back. Each subject will serve as their own control, with aqueous gel applied to the chest or back, and the non-aqueous gel (DBI-002 or vehicle) applied to the opposite side. Treatment kits will be assigned sequentially to subjects. The subject and the investigator will be blinded to the pre-defined randomization assignments. In this Phase IIA proof-of-mechanism study, cohorts 1, 2, and 3 were designed to be similar to a dose-escalating study. These cohorts will be enrolled sequentially, with a safety pause in between cohorts to evaluate events and/or local tolerability to topical application of the investigational product (DBI-002) or aqueous gel. Within each cohort, the first two subjects enrolled will have a single application of DBI-002 and aqueous gel, with a pause to assess adverse events and local tolerability. In the absence of safety concerns, the remaining subjects in that cohort will be enrolled to receive five consecutive daily applications of DBI-002 and aqueous gel. Cohort 1 will be low dose. Cohort 2 will be medium dose. Cohort 3 will be high dose. In the absence of safety concerns, the Investigator will proceed to enroll the next cohort, or extend (EXT) the enrollment of a cohort upon receiving Ethics Committee approval. Single-dose subjects remain in their original single-dose cohort assignment and do not dose-escalate, nor participate in the multiple-dose portion of that cohort, nor Cohort 4. The fourth cohort, Cohort 4, was designed to compare vehicle with aqueous gel. All subjects in this cohort will be required to receive five consecutive daily applications of vehicle and aqueous gel. The Investigator may enroll cohort 4 in parallel with the above cohorts.
Interventions
BIOLOGICALDBI-002 probiotic gel
Topical application on skin affected with tinea versicolor
BIOLOGICALAqueous gel
Topical application on skin affected with tinea versicolor
Sponsors
DermBiont, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Ability to understand, agree to and sign the study Informed Consent Form (ICF). If the subject is unable to provide consent him/herself, the subject's legally acceptable representative may provide written consent. 2. Male or Female Subjects of any race 18 - 65 years of age. 3. Subjects with a clinical diagnosis of Tinea versicolor (TV is a common benign superficial cutaneous fungal infection usually characterized by hypopigmented or hyperpigmented macules and patches on the chest and back). 4. A positive potassium hydroxide (KOH) examination consistent with Malassezia prior to the treatment period done at the clinical site. 5. Agree to not use soap and water on the chest and back for at least 12 hours before the study visits for Baseline/Day 1, Day 5, and Day 14, and follow all study instructions for use of soap and water on the chest and back during participation in the study.
Exclusion criteria
1. Females who are pregnant, planning a pregnancy, or breastfeeding. 2. Any dermatological conditions that could interfere with clinical evaluations or any disease state or physical condition which might expose the patient to an unacceptable risk by study participation. 3. Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see below). 4. Known sensitivity to any of the components of the study medication. 5. Use of a prescription or non-prescription topical treatment on the targeted TV anatomical locations within the previous 4 weeks, for example: anti-fungal, antibacterial or anti-microbial products, selenium and anti-inflammatories (e.g., corticosteroids). 6. Use of a systemic anti-fungal or antibiotic treatment for TV within the previous 4 weeks, Use of medicated shampoos and/or soaps within the previous 4 weeks. 7. Treatment of any type of cancer within the last 6 months. 8. History of any significant internal disease which contraindicates use of live microbiome (e.g. leukemia, liver failure, cardiovascular disease). 9. Subjects who are known to be allergic to any of the test product(s) or any components in the investigational product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure (IB). 10. AIDS or AIDS related complex by medical history. 11. Known or suspected use of immunosuppressive medications and/or has a known or suspected autoimmune disease. 12. Any subject not able to meet the study attendance requirements. 13. Subjects who have participated in any other trial of an investigational drug or device within 30 days prior to enrollment or participation in a research study concurrent with this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | 14 days of participation | The primary analysis will summarize the number of subjects with more qPCR DBI-002 drug product and more improvement in qPCR Malassezia (fungal cause of tinea versicolor) between DBI-002 Drug Product (Active) and aqueous gel (Control) at Day 5 or Day 14 versus Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Decrease in Signs and Symptoms of Tinea Versicolor for the DBI-002 DP-treated Lesion Compared to the Aqueous Gel Treated Lesion | 14 days of participation | The secondary analysis will summarize the number of subjects with more improvement in individual signs and symptoms of TV between DBI-002 Drug Product (Active) and aqueous gel (Control) at Day 5 or Day 14 versus Baseline |
Countries
El Salvador
Participant flow
Pre-assignment details
All subjects are required to have Tinea Versicolor on their chest and back, with no pre-assignment, as each subject functions as their own control. Each subject had test article (aqueous gel and active) applied, randomized, within treatment sites to 100cm2. The dose-escalating DBI-002 cohorts (1, 2, and 3) were enrolled in sequence, with a safety pause between cohorts to assess adverse events and local reactions to topical application. 34 total subjects were enrolled and received treatment.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Low dose 10\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel
Single treatment dose OR Once-daily application for 5 consecutive days | 6 |
| Cohort 2 Medium dose 10\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel
Single treatment dose OR Once-daily application for 5 consecutive days | 6 |
| Cohort 3 High dose 10\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel
Single treatment dose OR Once-daily application for 5 consecutive days | 6 |
| Cohort 1EXT Low dose 10\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel
Single treatment dose OR Once-daily application for 5 consecutive days | 4 |
| Cohort 2EXT Medium dose 10\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel
Single treatment dose OR Once-daily application for 5 consecutive days | 4 |
| Cohort 3EXT High dose 10\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel
Single treatment dose OR Once-daily application for 5 consecutive days | 4 |
| Cohort 4 Vehicle gel vs. aqueous (CMC) gel
Once-daily application for 5 consecutive days | 4 |
| Total | 34 |
Baseline characteristics
| Characteristic | Total | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 1EXT | Cohort 2EXT | Cohort 3EXT | Cohort 4 |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 6 Participants | 6 Participants | 6 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants |
| Age, Continuous | 32.0 Years STANDARD_DEVIATION 11.2 | 33.0 Years STANDARD_DEVIATION 10.6 | 24.5 Years STANDARD_DEVIATION 1.52 | 29.0 Years STANDARD_DEVIATION 8.22 | 29.0 Years STANDARD_DEVIATION 8.29 | 47.3 Years STANDARD_DEVIATION 13.6 | 31.3 Years STANDARD_DEVIATION 13.1 | 34.8 Years STANDARD_DEVIATION 13.1 |
| Clinical diagnosis of Tinea Versicolor on the chest and back | 34 Participants | 6 Participants | 6 Participants | 6 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 34 Participants | 6 Participants | 6 Participants | 6 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment El Salvador | 34 participants | 6 participants | 6 participants | 6 participants | 4 participants | 4 participants | 4 participants | 4 participants |
| Sex: Female, Male Female | 12 Participants | 0 Participants | 4 Participants | 4 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 22 Participants | 6 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 4 | 1 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 |
Outcome results
Primary
Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor)
The primary analysis will summarize the number of subjects with more qPCR DBI-002 drug product and more improvement in qPCR Malassezia (fungal cause of tinea versicolor) between DBI-002 Drug Product (Active) and aqueous gel (Control) at Day 5 or Day 14 versus Baseline.
Time frame: 14 days of participation
Population: The primary analysis will compare the differences at Day 5 between DBI-002 Drug Product (DP), vehicle gel, and/or aqueous gel in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 5 qPCR DBI-002 Drug Product: # Subjects where Active Improves More than Aqueous Gel (Control) | 2 Participants |
| Cohort 1 | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 14 qPCR DBI-002 Drug Product: # Subjects where Active Improves More than Aqueous Gel (Control) | 0 Participants |
| Cohort 1 | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 5 qPCR Malassezia(fungal cause of TV):# Subjects where Active Improves More than Aqueous Gel | 3 Participants |
| Cohort 1 | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 14 qPCR Malassezia(fungal cause of TV):# Subjects where Active Improves More than Aqueous Gel | 3 Participants |
| Cohort 2 | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 5 qPCR Malassezia(fungal cause of TV):# Subjects where Active Improves More than Aqueous Gel | 5 Participants |
| Cohort 2 | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 14 qPCR DBI-002 Drug Product: # Subjects where Active Improves More than Aqueous Gel (Control) | 1 Participants |
| Cohort 2 | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 5 qPCR DBI-002 Drug Product: # Subjects where Active Improves More than Aqueous Gel (Control) | 4 Participants |
| Cohort 2 | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 14 qPCR Malassezia(fungal cause of TV):# Subjects where Active Improves More than Aqueous Gel | 3 Participants |
| Cohort 3 | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 14 qPCR Malassezia(fungal cause of TV):# Subjects where Active Improves More than Aqueous Gel | 4 Participants |
| Cohort 3 | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 5 qPCR Malassezia(fungal cause of TV):# Subjects where Active Improves More than Aqueous Gel | 5 Participants |
| Cohort 3 | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 14 qPCR DBI-002 Drug Product: # Subjects where Active Improves More than Aqueous Gel (Control) | 4 Participants |
| Cohort 3 | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 5 qPCR DBI-002 Drug Product: # Subjects where Active Improves More than Aqueous Gel (Control) | 5 Participants |
| Cohort 1EXT | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 5 qPCR DBI-002 Drug Product: # Subjects where Active Improves More than Aqueous Gel (Control) | 1 Participants |
| Cohort 1EXT | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 14 qPCR Malassezia(fungal cause of TV):# Subjects where Active Improves More than Aqueous Gel | 3 Participants |
| Cohort 1EXT | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 14 qPCR DBI-002 Drug Product: # Subjects where Active Improves More than Aqueous Gel (Control) | 0 Participants |
| Cohort 1EXT | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 5 qPCR Malassezia(fungal cause of TV):# Subjects where Active Improves More than Aqueous Gel | 4 Participants |
| Cohort 2EXT | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 5 qPCR Malassezia(fungal cause of TV):# Subjects where Active Improves More than Aqueous Gel | 4 Participants |
| Cohort 2EXT | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 14 qPCR Malassezia(fungal cause of TV):# Subjects where Active Improves More than Aqueous Gel | 1 Participants |
| Cohort 2EXT | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 14 qPCR DBI-002 Drug Product: # Subjects where Active Improves More than Aqueous Gel (Control) | 0 Participants |
| Cohort 2EXT | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 5 qPCR DBI-002 Drug Product: # Subjects where Active Improves More than Aqueous Gel (Control) | 1 Participants |
| Cohort 3EXT | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 14 qPCR DBI-002 Drug Product: # Subjects where Active Improves More than Aqueous Gel (Control) | 2 Participants |
| Cohort 3EXT | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 5 qPCR Malassezia(fungal cause of TV):# Subjects where Active Improves More than Aqueous Gel | 2 Participants |
| Cohort 3EXT | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 14 qPCR Malassezia(fungal cause of TV):# Subjects where Active Improves More than Aqueous Gel | 1 Participants |
| Cohort 3EXT | Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor) | Day 5 qPCR DBI-002 Drug Product: # Subjects where Active Improves More than Aqueous Gel (Control) | 4 Participants |
Comparison: The analysis compared the differences at Day 5 between DBI-002 probiotic gel (active) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.p-value: 0.2Wilcoxon (Mann-Whitney)
Comparison: The analysis compared the differences at Day 14 between DBI-002 probiotic gel (active) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.p-value: 1Wilcoxon (Mann-Whitney)
Comparison: The analysis compared the differences at Day 5 between aqueous gel (control) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.p-value: 0.6Wilcoxon (Mann-Whitney)
Comparison: The analysis compared the differences at Day 14 between aqueous gel (control) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.p-value: 1Wilcoxon (Mann-Whitney)
Secondary
Proportion of Participants With Decrease in Signs and Symptoms of Tinea Versicolor for the DBI-002 DP-treated Lesion Compared to the Aqueous Gel Treated Lesion
The secondary analysis will summarize the number of subjects with more improvement in individual signs and symptoms of TV between DBI-002 Drug Product (Active) and aqueous gel (Control) at Day 5 or Day 14 versus Baseline
Time frame: 14 days of participation
Population: The proportion of subjects with a greater decrease in the scoring of individual signs and symptoms of TV for the DBI-002 Drug Product-treated lesion than the vehicle-treated or aqueous gel-treated lesion is be summarized descriptively for Days 5 and 14.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Proportion of Participants With Decrease in Signs and Symptoms of Tinea Versicolor for the DBI-002 DP-treated Lesion Compared to the Aqueous Gel Treated Lesion | Day 5 proportion of subjects with a greater decrease in the scoring of individual signs and symptoms | 2 Participants |
| Cohort 1 | Proportion of Participants With Decrease in Signs and Symptoms of Tinea Versicolor for the DBI-002 DP-treated Lesion Compared to the Aqueous Gel Treated Lesion | Day 14 proportion of subjects with a greater decrease in the scoring of individual signs and symptom | 3 Participants |
| Cohort 2 | Proportion of Participants With Decrease in Signs and Symptoms of Tinea Versicolor for the DBI-002 DP-treated Lesion Compared to the Aqueous Gel Treated Lesion | Day 5 proportion of subjects with a greater decrease in the scoring of individual signs and symptoms | 2 Participants |
| Cohort 2 | Proportion of Participants With Decrease in Signs and Symptoms of Tinea Versicolor for the DBI-002 DP-treated Lesion Compared to the Aqueous Gel Treated Lesion | Day 14 proportion of subjects with a greater decrease in the scoring of individual signs and symptom | 3 Participants |
| Cohort 3 | Proportion of Participants With Decrease in Signs and Symptoms of Tinea Versicolor for the DBI-002 DP-treated Lesion Compared to the Aqueous Gel Treated Lesion | Day 5 proportion of subjects with a greater decrease in the scoring of individual signs and symptoms | 2 Participants |
| Cohort 3 | Proportion of Participants With Decrease in Signs and Symptoms of Tinea Versicolor for the DBI-002 DP-treated Lesion Compared to the Aqueous Gel Treated Lesion | Day 14 proportion of subjects with a greater decrease in the scoring of individual signs and symptom | 3 Participants |
| Cohort 1EXT | Proportion of Participants With Decrease in Signs and Symptoms of Tinea Versicolor for the DBI-002 DP-treated Lesion Compared to the Aqueous Gel Treated Lesion | Day 5 proportion of subjects with a greater decrease in the scoring of individual signs and symptoms | 2 Participants |
| Cohort 1EXT | Proportion of Participants With Decrease in Signs and Symptoms of Tinea Versicolor for the DBI-002 DP-treated Lesion Compared to the Aqueous Gel Treated Lesion | Day 14 proportion of subjects with a greater decrease in the scoring of individual signs and symptom | 2 Participants |
| Cohort 2EXT | Proportion of Participants With Decrease in Signs and Symptoms of Tinea Versicolor for the DBI-002 DP-treated Lesion Compared to the Aqueous Gel Treated Lesion | Day 5 proportion of subjects with a greater decrease in the scoring of individual signs and symptoms | 1 Participants |
| Cohort 2EXT | Proportion of Participants With Decrease in Signs and Symptoms of Tinea Versicolor for the DBI-002 DP-treated Lesion Compared to the Aqueous Gel Treated Lesion | Day 14 proportion of subjects with a greater decrease in the scoring of individual signs and symptom | 1 Participants |
| Cohort 3EXT | Proportion of Participants With Decrease in Signs and Symptoms of Tinea Versicolor for the DBI-002 DP-treated Lesion Compared to the Aqueous Gel Treated Lesion | Day 5 proportion of subjects with a greater decrease in the scoring of individual signs and symptoms | 2 Participants |
| Cohort 3EXT | Proportion of Participants With Decrease in Signs and Symptoms of Tinea Versicolor for the DBI-002 DP-treated Lesion Compared to the Aqueous Gel Treated Lesion | Day 14 proportion of subjects with a greater decrease in the scoring of individual signs and symptom | 2 Participants |