Epidermolysis Bullosa
Conditions
Keywords
Epidermolysis Bullosa, Simplex, Recessive Dystrophic, Junctional non-Herlitz, Amicus Therapeutics, Scioderm, Inc., SD-101 6%, SD-101-6.0, Allantoin 6%, SD-101 3%, SD-101-3.0, Allantoin 3%, Zorblisa
Brief summary
The purpose of this study was to assess whether the topical use of SD-101 cream (3% or 6%) was effective in treating wounds in participants with Simplex, Recessive Dystrophic, or Junctional non-Herlitz Epidermolysis Bullosa (EB).
Detailed description
This was a Phase 2b, multi-center, randomized, double-blind, vehicle-controlled study to assess the efficacy and safety of SD-101 dermal cream (3% or 6%) on skin lesions in participants with Simplex, Recessive Dystrophic, or Junctional non-Herlitz EB. SD-101 cream \[containing 3% or 6% or vehicle (0%)\] was applied topically, once a day to the entire body for a period of 90 days. Eligible participants had a target wound assessed at baseline. Selected target wound had to be at least a certain age and within a prespecified size range at study entry. Photographic confirmation of the target wound location was collected at baseline, and the picture saved from the first visit was used to confirm location of the target wound at subsequent visits. The participant returned to the study site at Week 2, Month 1, Month 4, and Month 5 (at 14, 30, 60, and 90 days, respectively) to have the target wound previously identified at baseline re-assessed for the level of healing. In addition, changes in itching, pain, body surface area coverage of blisters and lesions, and scaring of the healed target wound were also assessed at each visit.
Interventions
DRUGSD-101 dermal cream (3%)
SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-3.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 3% and other excipients.
SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-6.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 6% and other excipients.
A white, crystalline powder that is formulated within an odorless, soft, white cream base. It contains no allantoin, only excipients.
Sponsors
Amicus Therapeutics
Scioderm, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed Consent form signed by the participant or the participant's legal representative; if the participant is under the age of majority but capable of providing assent, signed assent from the participant. * Participant (or caretaker) was willing to comply with all protocol requirements. * Diagnosis of Simplex, Recessive Dystrophic, or Junctional non-Herlitz EB. * Participants 6 months of age and older. * Participants had 1 target wound within a prespecified size range at study entry. * Target wound was at least 21 days or older.
Exclusion criteria
* Participants who did not meet all the entry criteria outlined in inclusion criteria. * Selected target wound had clinical evidence of local infection. * Use of any investigational drug within 30 days before enrollment. * Use of immunotherapy or cytotoxic chemotherapy within 60 days before enrollment. * Use of systemic or topical steroidal therapy within 30 days before enrollment (inhaled steroids and ophthalmic drops containing steroids were allowed). * Use of systemic antibiotics within 7 days before enrollment. * Current or former malignancy. * Arterial or venous disorder resulting in ulcerated wounds. * Diabetes mellitus. * Pregnancy or breastfeeding during the study (a urine pregnancy test was performed at screening for female participants of childbearing potential). * Females of childbearing potential who were not abstinent and not practicing a medically acceptable method of contraception. * Known history of cardiac, hepatic, or renal disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Documented Complete Closure Of The Target Wound Within 1 Month After Initiation Of Treatment | Baseline to 1 Month | The ARANZ SilhouetteStar™, a wound imaging, measurement, and documentation system providing accurate wound assessment, was used to measure the target wound at all visits. Information captured included photographic images, quantitative measures, and other target wound assessment data input to the device by the clinician, all obtained with no contact to the participant's skin. Information about the target wound's measurement history was available on this system so that the serial progression of the target wound status could also be calculated and presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment | Baseline to Month 2 and Month 3 | The ARANZ SilhouetteStar™, a wound imaging, measurement, and documentation system providing accurate wound assessment, was used to measure the target wound at all visits. Information captured included photographic images, quantitative measures, and other target wound assessment data input to the device by the clinician, all obtained with no contact to the participant's skin. Information about the target wound's measurement history was available on this system so that the serial progression of the target wound status could also be calculated and presented. |
| Percentage Change From Baseline In Lesional Skin Based On Body Surface Area Index (BSAI) Measurements At Month 3 | Baseline, Month 3 | The BSAI is a global measure of disease spread with weighting factors. Lesional skin consisted of area(s) that could contain any of the following: blisters, bullae, erosions, ulcerations, scabbing and eschars, as well as areas that are weeping, sloughing, oozing, crusted and denuded. The percentage, ranging from 0% to 100%, of affected body surface area was recorded for each defined body region (head/neck, upper limbs, trunk \[includes groin\], and lower limbs), multiplied by the weighting factor, and then summed for all body regions to calculate the BSAI. The BSAI affected with blisters and wounds was calculated at baseline and Month 3 to assess the total affected area. Percentage change from baseline was calculated as follows: Percentage change from baseline = 100\*(Post-baseline value minus Baseline value) divided by Baseline value. Mean percentage change from baseline in BSAI is reported. Only participants with data available for analysis at the specified time point are presented. |
| Participants Experiencing A Change From Baseline In Itching At Day 7 | Baseline, Day 7 | The Itch Man Pruritus Assessment Tool was used to measure the intensity of itching. Itching was assessed and reported at Baseline and Day 7. For participants 6 months to 5 years of age, itching was assessed using the caretaker's response, while in participants 6 years and older, itching was self-reported. |
| Change From Baseline In Pain At Day 7 | Baseline, Day 7 | Pain was assessed at Baseline and Day 7. The presence and intensity of pain was assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale for participants 6 months to 3 years of age. For participants aged 4 years and older, the Wong Faces Pain Scale was used. Scores were attributed for each of the 5 categories in the FLACC scale from 0 to 2, which resulted in a total score between 0 and 10. The Wong Faces Pain scale used 1 item to rate pain on a 0 to 10 scale. Higher score values indicated more pain. |
| Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Week 2, Month 1, Month 2, and Month 3 | In the event of a healed wound, where complete closure was confirmed, the extent of scarring was assessed as Present or Absent at all post-baseline visits (Week 2 and Months 1, 2, and 3). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SD-101 Dermal Cream (6%) SD-101 dermal cream (6%) applied topically once daily over the entire body for 90 days. | 15 |
| SD-101 Dermal Cream (3%) SD-101 dermal cream (3%) applied topically once daily over the entire body for 90 days. | 16 |
| Vehicle (0%) Vehicle dermal cream (SD-101 0%) applied topically once daily over the entire body for 90 days. | 17 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Vehicle (0%) | SD-101 Dermal Cream (6%) | SD-101 Dermal Cream (3%) |
|---|---|---|---|---|
| Age, Continuous | 12.19 years STANDARD_DEVIATION 12.029 | 11.57 years STANDARD_DEVIATION 10.358 | 9.55 years STANDARD_DEVIATION 9.189 | 15.32 years STANDARD_DEVIATION 15.565 |
| Epidermolysis Bullosa Subtype Junctional non-Herlitz | 8 Participants | 3 Participants | 2 Participants | 3 Participants |
| Epidermolysis Bullosa Subtype Recessive Dystrophic | 29 Participants | 10 Participants | 10 Participants | 9 Participants |
| Epidermolysis Bullosa Subtype Simplex | 11 Participants | 4 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants | 6 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 11 Participants | 11 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 42 Participants | 16 Participants | 11 Participants | 15 Participants |
| Sex: Female, Male Female | 22 Participants | 5 Participants | 9 Participants | 8 Participants |
| Sex: Female, Male Male | 26 Participants | 12 Participants | 6 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 16 | 0 / 17 |
| other Total, other adverse events | 9 / 15 | 13 / 16 | 12 / 17 |
| serious Total, serious adverse events | 0 / 15 | 2 / 16 | 1 / 17 |
Outcome results
Primary
Participants With Documented Complete Closure Of The Target Wound Within 1 Month After Initiation Of Treatment
The ARANZ SilhouetteStar™, a wound imaging, measurement, and documentation system providing accurate wound assessment, was used to measure the target wound at all visits. Information captured included photographic images, quantitative measures, and other target wound assessment data input to the device by the clinician, all obtained with no contact to the participant's skin. Information about the target wound's measurement history was available on this system so that the serial progression of the target wound status could also be calculated and presented.
Time frame: Baseline to 1 Month
Population: Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, and had received at least 1 application of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SD-101 Dermal Cream (6%) | Participants With Documented Complete Closure Of The Target Wound Within 1 Month After Initiation Of Treatment | Yes | 8 Participants |
| SD-101 Dermal Cream (6%) | Participants With Documented Complete Closure Of The Target Wound Within 1 Month After Initiation Of Treatment | No | 7 Participants |
| SD-101 Dermal Cream (3%) | Participants With Documented Complete Closure Of The Target Wound Within 1 Month After Initiation Of Treatment | Yes | 6 Participants |
| SD-101 Dermal Cream (3%) | Participants With Documented Complete Closure Of The Target Wound Within 1 Month After Initiation Of Treatment | No | 10 Participants |
| Vehicle (0%) | Participants With Documented Complete Closure Of The Target Wound Within 1 Month After Initiation Of Treatment | Yes | 7 Participants |
| Vehicle (0%) | Participants With Documented Complete Closure Of The Target Wound Within 1 Month After Initiation Of Treatment | No | 10 Participants |
p-value: =0.3699Fisher Exact
Secondary
Change From Baseline In Pain At Day 7
Pain was assessed at Baseline and Day 7. The presence and intensity of pain was assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale for participants 6 months to 3 years of age. For participants aged 4 years and older, the Wong Faces Pain Scale was used. Scores were attributed for each of the 5 categories in the FLACC scale from 0 to 2, which resulted in a total score between 0 and 10. The Wong Faces Pain scale used 1 item to rate pain on a 0 to 10 scale. Higher score values indicated more pain.
Time frame: Baseline, Day 7
Population: Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, and had received at least 1 application of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SD-101 Dermal Cream (6%) | Change From Baseline In Pain At Day 7 | FLACC Pain Scale | 0.50 score on a scale | Standard Deviation 0.707 |
| SD-101 Dermal Cream (6%) | Change From Baseline In Pain At Day 7 | Wong Faces Pain Scale | 0.91 score on a scale | Standard Deviation 2.119 |
| SD-101 Dermal Cream (3%) | Change From Baseline In Pain At Day 7 | FLACC Pain Scale | -0.17 score on a scale | Standard Deviation 5.307 |
| SD-101 Dermal Cream (3%) | Change From Baseline In Pain At Day 7 | Wong Faces Pain Scale | -0.70 score on a scale | Standard Deviation 2.908 |
| Vehicle (0%) | Change From Baseline In Pain At Day 7 | FLACC Pain Scale | -1.60 score on a scale | Standard Deviation 2.881 |
| Vehicle (0%) | Change From Baseline In Pain At Day 7 | Wong Faces Pain Scale | 1.08 score on a scale | Standard Deviation 2.353 |
Secondary
Participants Experiencing A Change From Baseline In Itching At Day 7
The Itch Man Pruritus Assessment Tool was used to measure the intensity of itching. Itching was assessed and reported at Baseline and Day 7. For participants 6 months to 5 years of age, itching was assessed using the caretaker's response, while in participants 6 years and older, itching was self-reported.
Time frame: Baseline, Day 7
Population: Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, and had received at least 1 application of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SD-101 Dermal Cream (6%) | Participants Experiencing A Change From Baseline In Itching At Day 7 | Missing | 1 Participants |
| SD-101 Dermal Cream (6%) | Participants Experiencing A Change From Baseline In Itching At Day 7 | Not Improved | 9 Participants |
| SD-101 Dermal Cream (6%) | Participants Experiencing A Change From Baseline In Itching At Day 7 | Improved | 5 Participants |
| SD-101 Dermal Cream (3%) | Participants Experiencing A Change From Baseline In Itching At Day 7 | Not Improved | 12 Participants |
| SD-101 Dermal Cream (3%) | Participants Experiencing A Change From Baseline In Itching At Day 7 | Improved | 4 Participants |
| SD-101 Dermal Cream (3%) | Participants Experiencing A Change From Baseline In Itching At Day 7 | Missing | 0 Participants |
| Vehicle (0%) | Participants Experiencing A Change From Baseline In Itching At Day 7 | Improved | 7 Participants |
| Vehicle (0%) | Participants Experiencing A Change From Baseline In Itching At Day 7 | Missing | 0 Participants |
| Vehicle (0%) | Participants Experiencing A Change From Baseline In Itching At Day 7 | Not Improved | 10 Participants |
Secondary
Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment
The ARANZ SilhouetteStar™, a wound imaging, measurement, and documentation system providing accurate wound assessment, was used to measure the target wound at all visits. Information captured included photographic images, quantitative measures, and other target wound assessment data input to the device by the clinician, all obtained with no contact to the participant's skin. Information about the target wound's measurement history was available on this system so that the serial progression of the target wound status could also be calculated and presented.
Time frame: Baseline to Month 2 and Month 3
Population: Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, and had received at least 1 application of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SD-101 Dermal Cream (6%) | Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment | Yes: Month 3 | 9 Participants |
| SD-101 Dermal Cream (6%) | Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment | Yes: Month 2 | 9 Participants |
| SD-101 Dermal Cream (6%) | Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment | No: Month 3 | 6 Participants |
| SD-101 Dermal Cream (6%) | Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment | No: Month 2 | 6 Participants |
| SD-101 Dermal Cream (3%) | Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment | Yes: Month 3 | 9 Participants |
| SD-101 Dermal Cream (3%) | Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment | No: Month 2 | 9 Participants |
| SD-101 Dermal Cream (3%) | Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment | Yes: Month 2 | 7 Participants |
| SD-101 Dermal Cream (3%) | Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment | No: Month 3 | 7 Participants |
| Vehicle (0%) | Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment | No: Month 2 | 10 Participants |
| Vehicle (0%) | Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment | Yes: Month 2 | 7 Participants |
| Vehicle (0%) | Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment | No: Month 3 | 8 Participants |
| Vehicle (0%) | Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment | Yes: Month 3 | 9 Participants |
Secondary
Participants With Scarring At Week 2, Month 1, Month 2, And Month 3
In the event of a healed wound, where complete closure was confirmed, the extent of scarring was assessed as Present or Absent at all post-baseline visits (Week 2 and Months 1, 2, and 3).
Time frame: Week 2, Month 1, Month 2, and Month 3
Population: Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, had received at least 1 application of study drug, and whose target wounds healed while receiving study drug.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SD-101 Dermal Cream (6%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Week 2 | Present | 0 Participants |
| SD-101 Dermal Cream (6%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Week 2 | Absent | 4 Participants |
| SD-101 Dermal Cream (6%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Month 1 | Present | 2 Participants |
| SD-101 Dermal Cream (6%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Month 1 | Absent | 2 Participants |
| SD-101 Dermal Cream (6%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Month 2 | Present | 0 Participants |
| SD-101 Dermal Cream (6%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Month 2 | Absent | 1 Participants |
| SD-101 Dermal Cream (6%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Month 3 | Present | 0 Participants |
| SD-101 Dermal Cream (6%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Month 3 | Absent | 0 Participants |
| SD-101 Dermal Cream (3%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Month 1 | Present | 2 Participants |
| SD-101 Dermal Cream (3%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Month 3 | Present | 0 Participants |
| SD-101 Dermal Cream (3%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Month 1 | Absent | 3 Participants |
| SD-101 Dermal Cream (3%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Month 2 | Present | 1 Participants |
| SD-101 Dermal Cream (3%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Month 2 | Absent | 0 Participants |
| SD-101 Dermal Cream (3%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Week 2 | Present | 0 Participants |
| SD-101 Dermal Cream (3%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Week 2 | Absent | 1 Participants |
| SD-101 Dermal Cream (3%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Month 3 | Absent | 2 Participants |
| Vehicle (0%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Month 1 | Present | 2 Participants |
| Vehicle (0%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Week 2 | Absent | 2 Participants |
| Vehicle (0%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Week 2 | Present | 0 Participants |
| Vehicle (0%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Month 1 | Absent | 3 Participants |
| Vehicle (0%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Month 3 | Present | 0 Participants |
| Vehicle (0%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Month 2 | Absent | 0 Participants |
| Vehicle (0%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Month 2 | Present | 0 Participants |
| Vehicle (0%) | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Month 3 | Absent | 2 Participants |
Secondary
Percentage Change From Baseline In Lesional Skin Based On Body Surface Area Index (BSAI) Measurements At Month 3
The BSAI is a global measure of disease spread with weighting factors. Lesional skin consisted of area(s) that could contain any of the following: blisters, bullae, erosions, ulcerations, scabbing and eschars, as well as areas that are weeping, sloughing, oozing, crusted and denuded. The percentage, ranging from 0% to 100%, of affected body surface area was recorded for each defined body region (head/neck, upper limbs, trunk \[includes groin\], and lower limbs), multiplied by the weighting factor, and then summed for all body regions to calculate the BSAI. The BSAI affected with blisters and wounds was calculated at baseline and Month 3 to assess the total affected area. Percentage change from baseline was calculated as follows: Percentage change from baseline = 100\*(Post-baseline value minus Baseline value) divided by Baseline value. Mean percentage change from baseline in BSAI is reported. Only participants with data available for analysis at the specified time point are presented.
Time frame: Baseline, Month 3
Population: Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, and had received at least 1 application of study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SD-101 Dermal Cream (6%) | Percentage Change From Baseline In Lesional Skin Based On Body Surface Area Index (BSAI) Measurements At Month 3 | -28.02 percentage of BSAI | Standard Deviation 35.949 |
| SD-101 Dermal Cream (3%) | Percentage Change From Baseline In Lesional Skin Based On Body Surface Area Index (BSAI) Measurements At Month 3 | -42.52 percentage of BSAI | Standard Deviation 37.624 |
| Vehicle (0%) | Percentage Change From Baseline In Lesional Skin Based On Body Surface Area Index (BSAI) Measurements At Month 3 | -5.75 percentage of BSAI | Standard Deviation 110.47 |