Drug updated on 12/11/2024
Dosage Form | Gel (topical; 10%) |
Drug Class | Botanical |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa in adult and pediatric patients 6 months of age and older.
Latest News
Summary
- This summary is based on the review of one randomized controlled trial. [1]
- Oleogel-S10 (birch triterpenes) achieved complete closure of the target wound in 41.3% of patients within 45 days, compared to 28.9% in the control group.
- The relative risk (RR) for wound closure with Oleogel-S10 compared to the control gel was 1.44 (95% confidence interval (CI), 1.01 to 2.05; P = 0.013), indicating a statistically significant improvement in wound healing.
- The study population included patients with dystrophic, junctional, or Kindler epidermolysis bullosa (EB), with target wounds of partial thickness lasting between 21 days and 9 months, sized 10-50 cm². However, no specific subgroup analysis based on EB types was reported.
- Adverse events (AES) were reported in 81.7% of patients treated with Oleogel-S10 and 80.7% of patients using the control gel. Most AEs were mild to moderate, with 4.6% being severe.
- The frequency and intensity of AEs were similar between the Oleogel-S10 and control gel groups, with no significant safety concerns or adverse effects specific to particular population types or subgroups noted.
- The study population included patients with dystrophic, junctional, or Kindler EB, with target partial-thickness wounds lasting between 21 days and 9 months and sized 10-50 cm². The abstract does not provide further details on effectiveness or safety outcomes across different EB subtypes or other specific subgroups.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Filsuvez (birch triterpenes) Prescribing Information. | 2024 | Chiesi USA, Inc., |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Efficacy and safety of Oleogel-S10 (birch triterpenes) for epidermolysis bullosa: results from the phase III randomized double-blind phase of the EASE study | 223Subjects F: 40% M: 60% | 2023 | British Journal of Dermatology |
Sex Distribution:
F:40%
M:60%
223Subjects
Year:
2023
Source:British Journal of Dermatology