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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01FD005093-01 | U.S. FDA Grant/Contract | View source |
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The Sponsor voluntarily recalled SD-101 and terminated the study due to GMP deficiencies identified during an FDA inspection at the site of the manufacturer.
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| Name | Class |
|---|---|
| Amicus Therapeutics | INDUSTRY |
| Food and Drug Administration (FDA) | FED |
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The purpose of this study was to assess the continued safety of topical use of SD-101 cream (6%) in participants with Epidermolysis Bullosa (EB).
Funding Source: FDA Office of Orphan Products Development
This was an open-label extension study to assess the continued safety of topically applied SD-101 dermal cream (6%) in participants with Simplex, Recessive Dystrophic, and Junctional non-Herlitz EB.
SD-101 dermal cream (6%) was applied topically, once a day to the entire body for the duration of the study. Participants who successfully completed the entire SD-003 study (NCT02014376) had the option to roll over into the SD-004 study (NCT02090283). The baseline visit occurred at the final visit date for the SD-003 study. The body surface area (BSA) coverage of blisters and lesions assessment made at the final SD-003 study visit were used as the baseline information at the baseline visit for the SD-004 study. Participants returned to the study site for the following 13 visits (36 months) to have BSA assessed. BSA was assessed at all subsequent scheduled study center visits. Scheduled study center visits occurred every 6 months after Month 36 (Month 42, 48, and so on). After completion of Month 36, the next participant visit (Month 39) was a phone call from the site to the participant. Telephone visits occurred every 6 months thereafter (Month 45, 51, and so on) and included assessment of adverse events and concomitant medications only. For female participants of childbearing potential, a urine pregnancy test was performed at Month 6 and every 6 months up to and including the final study visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SD-101 Dermal Cream (6%) | Experimental | All participants applied SD-101 dermal cream topically, once a day, to the entire body for the duration of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SD-101 dermal cream (6%) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number Of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent adverse events were defined as adverse events that started or worsened on or after baseline visit, which occurred at the final visit date for the SD-003 study. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. | From baseline to 30 days after last application of study drug (up to a maximum of 54 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin At Month 24 | Lesional skin was defined as areas that contained any of the following: blisters, erosions, ulcerations, scabbing, bullae, or eschars, as well as areas that were weeping, sloughing, oozing, crusted, or denuded. The percentage, ranging from 0% to 100%, of affected body surface area (BSA) was recorded for each defined body region (that is, 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 BSA for lesional skin was to be assessed by the same study physician on each visit for a particular participant. The mean change from baseline (final visit from the SD-003 study) in BSAI was assessed every 3 months. Only participants with data available for analysis at the specified time point are presented. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Amicus Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Alto | California | 94304 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Paller A., Browning J., Aslam R., et al. Efficacy and Safety Results From a 24-Month, Open-Label Extension of a Phase 2b Dose-Ranging Study of SD-101 Cream in Patients With Epidermolysis Bullosa. Abstract presented at European Academy of Dermatology and Venereology, 26th Congress, Geneva, Switzerland, September 13-17, 2017. |
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Analysis groups were defined based on prior treatment in Study SD-003: those who received placebo were allocated to the 'Placebo to SD-101-6.0' group, those who received SD-101-3.0 were allocated to the 'SD-101-3.0 to SD-101-6.0' group, and those who received SD-101-6.0 were allocated to the 'SD-101-6.0 to SD-101-6.0' group.
42 participants with epidermolysis bullosa (EB) were enrolled in this open-label, multi-center extension study. All enrolled participants had previously completed Study SD-003 (NCT02014376).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo to SD-101-6.0 | Participants who received placebo in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body. |
| FG001 | SD-101-3.0 to SD-101-6.0 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2017 | Sep 3, 2019 |
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|
| Baseline, Month 24 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| St Louis | Missouri | 63110 | United States |
| Hackensack | New Jersey | 07601 | United States |
| Chapel Hill | North Carolina | 27516 | United States |
| San Antonio | Texas | 78218 | United States |
| Seattle | Washington | 98105 | United States |
Participants who received SD-101-3.0 in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body.
| FG002 | SD-101-6.0 to SD-101-6.0 | Participants who received SD-101-6.0 in Study SD-003 continued to receive SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body. |
| Received At Least 1 Dose Of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety: All participants who successfully rolled over into the SD-004 study from the SD-003 study and applied/were administered at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo to SD-101-6.0 | Participants who received placebo in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body. |
| BG001 | SD-101-3.0 to SD-101-6.0 | Participants who received SD-101-3.0 in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body. |
| BG002 | SD-101-6.0 to SD-101-6.0 | Participants who received SD-101-6.0 in Study SD-003 continued to receive SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| EB Subtype | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number Of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent adverse events were defined as adverse events that started or worsened on or after baseline visit, which occurred at the final visit date for the SD-003 study. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. | Safety: All participants who successfully rolled over into the SD-004 study from the SD-003 study and applied/were administered at least 1 dose of study drug. | Posted | Count of Participants | Participants | From baseline to 30 days after last application of study drug (up to a maximum of 54 months) |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin At Month 24 | Lesional skin was defined as areas that contained any of the following: blisters, erosions, ulcerations, scabbing, bullae, or eschars, as well as areas that were weeping, sloughing, oozing, crusted, or denuded. The percentage, ranging from 0% to 100%, of affected body surface area (BSA) was recorded for each defined body region (that is, 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 BSA for lesional skin was to be assessed by the same study physician on each visit for a particular participant. The mean change from baseline (final visit from the SD-003 study) in BSAI was assessed every 3 months. Only participants with data available for analysis at the specified time point are presented. | Intent to Treat: All participants who successfully rolled over into the SD-004 study from the SD-003 study and applied/were administered at least 1 dose of study drug. | Posted | Mean | Standard Deviation | percentage of BSAI | Baseline, Month 24 |
|
From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo to SD-101-6.0 | Participants who received placebo in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body. | 0 | 17 | 4 | 17 | 13 | 17 |
| EG001 | SD-101-3.0 to SD-101-6.0 | Participants who received SD-101-3.0 in Study SD-003 received SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body. | 0 | 15 | 2 | 15 | 13 | 15 |
| EG002 | SD-101-6.0 to SD-101-6.0 | Participants who received SD-101-6.0 in Study SD-003 continued to receive SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body. | 0 | 10 | 0 | 10 | 5 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cyanosis | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myopia | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oesophageal perforation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Application site pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Developmental delay | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gallbladder pain | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bacterial disease carrier | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Corona virus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Stoma site cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Pancreatic enzymes decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Serum ferritin decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Underweight | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pseudosyndactyly | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Borderline personality disorder | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cholecystectomy | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
| |
| Cyst removal | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
|
Results are presented for all participants who received SD-101 before the early termination of the study on 4 June 2018. The maximum study duration completed by at least 1 participant was 54 months.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patient Advocacy | Amicus Therapeutics, Inc. | +1-609-662-2000 | clinicaltrials@amicusrx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 20, 2018 | Sep 3, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D004820 | Epidermolysis Bullosa |
| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012872 | Skin Diseases, Vesiculobullous |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African-American |
|
| Asian |
|
| Recessive Dystrophic |
|
| Junctional non-Herlitz |
|
|
| Any Fatal TEAE |
|
| Serious TEAE |
|
| Any TEAE Leading to Discontinuation |
|
| OG002 | SD-101-6.0 to SD-101-6.0 | Participants who received SD-101-6.0 in Study SD-003 continued to receive SD-101-6.0 in this open-label extension study. SD-101-6.0 was applied topically, once a day, to the entire body. |
|
|