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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003390-26 | EudraCT Number |
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The main purpose of this phase III clinical trial was to show safety and efficacy of Oleogel-S10 in accelerating the wound healing of Split-Thickness Skin Graft (STSG) donor sites.
Oleogel-S10 has shown efficacy and was well tolerated in previous clinical trials in participants with skin lesions. Especially the results in a previous study with STSG donor sites suggested that Oleogel-S10 should be efficacious and safe in the treatment of superficial wounds.
The present phase III clinical trial in STSG donor sites was initiated to demonstrate wound healing progress, i.e., the time to healing and the grade of epithelialization of the wound.
In this study, STSG donor sites were separated into 2 wound halves. Randomly assigned, 1 wound half was treated with Oleogel-S10 and non-adhesive wound dressing, the other wound half with non-adhesive wound dressing only (standard of care).
Wound healing progress was documented by photos which were assessed by expert reviewers blinded to the treatment of the wound halves.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oleogel-S10, non-adhesive wound dressing | Experimental | A split-thickness skin graft (STSG) donor site wound >15cm2 in size was divided in 2 halves. One half was randomized to Oleogel-S10 treatment and non-adhesive wound dressing (intra-individual comparison). Oleogel-S10 was administered (1 cm or 100 mg per cm2 wound area corresponding to thickness of about 1 mm or 0.04 inch) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28. |
|
| Non-adhesive wound dressing only | Other | A STSG donor site wound >15cm2 in size was divided in 2 halves. One half was randomized to treatment with non-adhesive wound dressing only (intra-individual comparison). Non-adhesive wound dressings are standard of care (SOC) in the treatment of STSG donor sites. Wound dressings were changed every 3 to 4 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oleogel-S10, non-adhesive wound dressing | Drug | 1 cm or 100 mg Oleogel-S10 per cm2 wound area (corresponds to thickness of approximately 1 mm or 0.04 inch) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-individual Difference in Time to Wound Closure | Intra-individual difference in time to wound closure between wound halves, either treated with Oleogel-S10 and non-adhesive wound dressing or treated with non-adhesive wound dressing only. Independent experts were blind to treatment and assessed efficacy based on chronological series of cropped and coded photographs by wound half that were taken before start of treatment, during wound dressing changes and at the end of treatment. Difference in time to wound closure was calculated for every individual participant as [time taken for wound half treated with Oleogel-S10 to close] - [time taken for wound half treated with non-adhesive wound dressing to close], i.e., results below 0 indicate earlier wound closure of Oleogel-S10 treatment. The overall mean difference in time to wound closure was calculated based on all mean differences in time to wound closure of individual participants. Hence, primary outcome data derived from mean difference in time to wound closure by participant. | 2 to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Surgery Until Wound Closure is Achieved | Time from surgery until wound closure is achieved, separately for wound halves treated with Oleogel-S10 and non-adhesive wound dressing vs. non-adhesive wound dressing only. While outcome measure 1 (intra-individual difference in time to wound closure) was calculated based on mean intra-individual difference in time to wound closure in 110 participants with missing values replaced by a value of 0, for outcome measure 2 missing values were not replaced. For 2 of the 110 wounds data were missing, thus the reported values are calculated from 108 STSG donor site wound halves by intervention (Oleogel-S10 and non-adhesive wound dressing vs. non-adhesive wound dressing only). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Pedro Barret Nerin, MD | Hospital Universitari Vall d´Hebron, Barcelona, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | France | ||||
| Hôpital de la Conception |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28400148 | Background | Barret JP, Podmelle F, Lipovy B, Rennekampff HO, Schumann H, Schwieger-Briel A, Zahn TR, Metelmann HR; BSH-12 and BSG-12 study groups. Accelerated re-epithelialization of partial-thickness skin wounds by a topical betulin gel: Results of a randomized phase III clinical trials program. Burns. 2017 Sep;43(6):1284-1294. doi: 10.1016/j.burns.2017.03.005. Epub 2017 Apr 8. |
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113 participants were screened and wound halves of 112 participants were randomized and treated. For one participant, wound halves were neither randomized nor treated because the split-thickness skin graft surgery was cancelled. Overall, 112 wounds in 112 participants were treated.
Participants were enrolled from 04 Apr 2013 to 04 Sep 2013 in 14 clinical centers in 4 countries: Spain (6 centers), Greece (3 centers), Latvia (2 centers), and France (3 centers).
| ID | Title | Description |
|---|---|---|
| FG000 | Entire Study Population | A split-thickness skin graft (STSG) donor site wound >15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to Oleogel-S10 treatment plus non-adhesive wound dressing. The other wound half was covered with a non-adhesive wound dressing only as control (intra-individual comparison) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Intra-individual comparison: A split-thickness skin graft (STSG) donor site wound ≥15 cm² in size was divided in 2 halves. One half was randomized to Oleogel-S10 treatment and non-adhesive wound dressing, the other half to non-adhesive wound dressing only. Non-adhesive wound dressings, specifically soft silicone faced polyurethane foam dressings (e.g., Mepilex®), represent standard of care (SOC) in the treatment of STSG donor site wounds. Oleogel-S10 was administered at a thickness of 1 mm (0.04 inches) and wound dressings were changed at least every 3 to 4 days. Study treatment continued until both wound halves were closed (at least 95% epithelialised) or ended at Day 28. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Intra-individual Difference in Time to Wound Closure | Intra-individual difference in time to wound closure between wound halves, either treated with Oleogel-S10 and non-adhesive wound dressing or treated with non-adhesive wound dressing only. Independent experts were blind to treatment and assessed efficacy based on chronological series of cropped and coded photographs by wound half that were taken before start of treatment, during wound dressing changes and at the end of treatment. Difference in time to wound closure was calculated for every individual participant as [time taken for wound half treated with Oleogel-S10 to close] - [time taken for wound half treated with non-adhesive wound dressing to close], i.e., results below 0 indicate earlier wound closure of Oleogel-S10 treatment. The overall mean difference in time to wound closure was calculated based on all mean differences in time to wound closure of individual participants. Hence, primary outcome data derived from mean difference in time to wound closure by participant. | The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. | Posted | Mean | 95% Confidence Interval | days | 2 to 4 weeks |
Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
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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 | Entire Study Population - Systemic Adverse Events (AE) | All participants treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only. AEs not localized to any wound application site by the investigator are reported in this arm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Development | Amryt Pharma | +353 1 518 0200 | medinfo@amrytpharma.com |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C000631524 | episalvan |
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|
| Non-adhesive wound dressing only | Device | Soft silicone faced polyurethane foam dressing such as Mepilex® only every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28 |
|
|
| 2 to 4 weeks |
| Percentage of Participants With Earlier Healing | Percentage of participants with earlier healing of wound area treated with Oleogel-S10 and non-adhesive wound dressing compared to non-adhesive wound dressing only | 2 to 4 weeks |
| Percentage of Participants With Wound Closure at Different Time Points | For separate time points (Day 7, Day 10, Day 14, Day 18, Day 21, and Day 28), the frequencies of wound areas which have reached wound closure were calculated. | 2 to 4 weeks |
| Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator | A study team member assessed the progress of wound healing by treatment regimen and noted the degree of epithelialization (expressed in percent of the original wound size) at wound dressing changes on Day 7, Day 10, Day 14, Day 18, Day 21, and Day 28. | 2 to 4 weeks |
| Likert Scale Rating of Efficacy | Participants and investigators were asked to grade the efficacy of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only on a 5-point Likert scale (treatment with Oleogel-S10 is much more effective, treatment with Oleogel-S10 is more effective, both treatments have the same efficacy, non-adhesive wound dressing only is more effective, non-adhesive wound dressing only is much more effective). | 2 to 4 weeks |
| Cosmetic Outcome at 3 and 12 Months After Surgery, Respectively | Blinded photographic evaluation which wound half resembles more closely the surrounding skin with regard to texture, redness, growth of hair, and pigmentation. | 3 months and 12 months |
| Likert Scale Rating of Tolerability | Participants and investigators were asked to evaluate the tolerability of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only (standard of care) on a 5-point Likert scale (treatment with Oleogel-S10 is much better tolerated, treatment with Oleogel-S10 is better tolerated, both treatments are equally well tolerated, non-adhesive wound dressing only is better tolerated, non-adhesive wound dressing only is much better tolerated). | 2 to 4 weeks |
| Pharmacokinetic (PK) Data (Number of Plasma Samples With Measurable Betulin Concentration) | Systemic presence/concentration of betulin in blood plasma samples. Plasma samples were collected in weekly intervals and at the end of treatment (when wound closure was achieved or at Day 28). Samples were analysed in a central laboratory with a validated LC-MS/MS method with a lower limit of quantification (LLOQ) of 1 ng/mL. | up to 4 weeks |
| Pharmacokinetic (PK) Data (Plasma Betulin Concentration) | Systemic presence/concentration of betulin in blood plasma samples - values for the number of samples with measurable values in samples above the lower limit of quantification (LLOQ) of 1 ng/mL | up to 4 weeks |
| Frequency of Adverse Events | Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier). |
| Severity of Adverse Events | Adverse Events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) as being mild (NCI CTCAE Grade 1), moderate (NCI CTCAE Grade 2), severe (NCI CTCAE Grade 3), life-threatening (NCI CTCAE Grade 4) or death (NCI CTCAE Grade 5). | Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier). |
| Adverse Events by Relationship to Study Medication | Adverse events were assessed as being 'unlikely', 'possibly' or 'probably' related to study medication, 'not related' to study medication or the relationship to study medication was rated as 'unknown'. | Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier). |
| Marseille |
| France |
| CHU de Nantes | Nantes | France |
| KAT General Hospital of Attica | Athens | Greece |
| National University, "Andreas Syggros" Skin & Venereal Diseases Hospital | Athens | Greece |
| Aristotle University General Hospital | Thessaloniki | Greece |
| Riga East University Hospital, Microsurgery Center | Riga | Latvia |
| Riga East University Hospital, State Burn Center | Riga | Latvia |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain |
| Hospital Universitario de Getafe | Madrid | Spain |
| Hopital Universitari i Politecnic La Fe | Valencia | Spain |
| Hospital Universitario Rio Ortega | Valladolid | Spain |
| Hospital Miguel Servet | Zaragoza | Spain |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Entire Study Population | All participants treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only |
|
|
|
| Secondary | Time From Surgery Until Wound Closure is Achieved | Time from surgery until wound closure is achieved, separately for wound halves treated with Oleogel-S10 and non-adhesive wound dressing vs. non-adhesive wound dressing only. While outcome measure 1 (intra-individual difference in time to wound closure) was calculated based on mean intra-individual difference in time to wound closure in 110 participants with missing values replaced by a value of 0, for outcome measure 2 missing values were not replaced. For 2 of the 110 wounds data were missing, thus the reported values are calculated from 108 STSG donor site wound halves by intervention (Oleogel-S10 and non-adhesive wound dressing vs. non-adhesive wound dressing only). | The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. For 2 of the 110 wounds, data were missing, thus the reported values are calculated from 108 STSG donor site wound halves by intervention | Posted | Mean | 95% Confidence Interval | Days from surgery until wound closure | 2 to 4 weeks | STSG Wound (Halves) | STSG Wound (Halves) |
|
|
|
| Secondary | Percentage of Participants With Earlier Healing | Percentage of participants with earlier healing of wound area treated with Oleogel-S10 and non-adhesive wound dressing compared to non-adhesive wound dressing only | The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. | Posted | Number | 95% Confidence Interval | Percentage with earlier healing | 2 to 4 weeks |
|
|
|
| Secondary | Percentage of Participants With Wound Closure at Different Time Points | For separate time points (Day 7, Day 10, Day 14, Day 18, Day 21, and Day 28), the frequencies of wound areas which have reached wound closure were calculated. | The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. Data were missing for n=2 participants at all time points. | Posted | Number | 95% Confidence Interval | Percentage with wound closure | 2 to 4 weeks |
|
|
|
| Secondary | Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator | A study team member assessed the progress of wound healing by treatment regimen and noted the degree of epithelialization (expressed in percent of the original wound size) at wound dressing changes on Day 7, Day 10, Day 14, Day 18, Day 21, and Day 28. | The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. | Posted | Mean | 95% Confidence Interval | Area Percent of initial wound size | 2 to 4 weeks |
|
|
|
|
| Secondary | Likert Scale Rating of Efficacy | Participants and investigators were asked to grade the efficacy of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only on a 5-point Likert scale (treatment with Oleogel-S10 is much more effective, treatment with Oleogel-S10 is more effective, both treatments have the same efficacy, non-adhesive wound dressing only is more effective, non-adhesive wound dressing only is much more effective). | The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. | Posted | Number | 95% Confidence Interval | Percentage of efficacy assessments | 2 to 4 weeks |
|
|
|
| Secondary | Cosmetic Outcome at 3 and 12 Months After Surgery, Respectively | Blinded photographic evaluation which wound half resembles more closely the surrounding skin with regard to texture, redness, growth of hair, and pigmentation. | The intent-to-treat (ITT) analysis population included 96 participants for the 3-months follow-up and 65 participants for the 12-months follow-up. *Note: The assessment for one patient was missing as no photo was not taken at the Month 3 follow-up visit, therefore this outcome measure is based on 95 patients | Posted | Number | 95% Confidence Interval | Percentage of wounds | 3 months and 12 months |
|
|
|
| Secondary | Likert Scale Rating of Tolerability | Participants and investigators were asked to evaluate the tolerability of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only (standard of care) on a 5-point Likert scale (treatment with Oleogel-S10 is much better tolerated, treatment with Oleogel-S10 is better tolerated, both treatments are equally well tolerated, non-adhesive wound dressing only is better tolerated, non-adhesive wound dressing only is much better tolerated). | The safety analysis population (SAF) included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF. | Posted | Number | Percentage of participants | 2 to 4 weeks |
|
|
|
| Secondary | Pharmacokinetic (PK) Data (Number of Plasma Samples With Measurable Betulin Concentration) | Systemic presence/concentration of betulin in blood plasma samples. Plasma samples were collected in weekly intervals and at the end of treatment (when wound closure was achieved or at Day 28). Samples were analysed in a central laboratory with a validated LC-MS/MS method with a lower limit of quantification (LLOQ) of 1 ng/mL. | The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF. | Posted | Number | Plasma Samples | up to 4 weeks | Plasma Samples | Plasma Samples |
|
|
|
| Secondary | Pharmacokinetic (PK) Data (Plasma Betulin Concentration) | Systemic presence/concentration of betulin in blood plasma samples - values for the number of samples with measurable values in samples above the lower limit of quantification (LLOQ) of 1 ng/mL | A total of 13 participants had a total of 15 samples with betulin concentrations above the LLOQ (1 ng/mL), 2 participants with 2 samples each above LLOQ | Posted | Mean | Full Range | Betulin (ng/mL) | up to 4 weeks | Samples above LLOQ | Samples above LLOQ |
|
|
|
| Secondary | Frequency of Adverse Events | The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF. | Posted | Number | Participants with adverse events (%) | Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier). |
|
|
|
| Secondary | Severity of Adverse Events | Adverse Events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) as being mild (NCI CTCAE Grade 1), moderate (NCI CTCAE Grade 2), severe (NCI CTCAE Grade 3), life-threatening (NCI CTCAE Grade 4) or death (NCI CTCAE Grade 5). | The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF. | Posted | Number | Participants with adverse events (%) | Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier). |
|
|
|
| Secondary | Adverse Events by Relationship to Study Medication | Adverse events were assessed as being 'unlikely', 'possibly' or 'probably' related to study medication, 'not related' to study medication or the relationship to study medication was rated as 'unknown'. | The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF. | Posted | Number | Participants with adverse events (%) | Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier). |
|
|
|
| 4 |
| 112 |
| 30 |
| 112 |
| EG001 | Oleogel-S10 Localized Adverse Event (AE) | All participants treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred only at the Oleogel-S10 wound half are reported in this arm. | 0 | 112 | 2 | 112 |
| EG002 | Non-adhesive Wound Dressing Localized AE | All participants treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred only at the wound half treated with non-adhesive wound dressing only are reported in this arm. | 0 | 112 | 4 | 112 |
| EG003 | Localized AE Both Wound Halves | All participants treated with Oleogel-S10 and non-adhesive wound dressing and non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred at both the Oleogel-S10 wound half and the non-adhesive wound dressing only half in one participant are reported in this arm. | 1 | 112 | 9 | 112 |
| EG004 | Entire Study Population -Systemic and Localized AEs | All participants treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only. Local and systemic AEs are reported in this arm. | 5 | 112 | 40 | 112 |
| Sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment | Post-operative wound necrosis on the site of a flap intake on the right leg |
|
| Mania | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bacteremia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
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| Day 14 |
|
| Day 18 |
|
| Day 21 |
|
| Day 28 |
|
| Day 14 |
|
| Day 18 |
|
| Day 21 |
|
| Day 28 |
|
| t-test, 2 sided |
| =0.0002 |
Day 10 |
| Mean Difference (Final Values) |
| 6.2 |
| Standard Deviation |
| 16.9 |
| 2-Sided |
| 95 |
| 3.0 |
| 9.4 |
Mean difference in degree of epithelialization [%] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only) |
| Superiority or Other |
| t-test, 2 sided | =0.0028 | Day 14 | Mean Difference (Final Values) | 5.6 | Standard Deviation | 19.3 | 2-Sided | 95 | 2.0 | 9.3 | Mean difference in degree of epithelialization [%] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only) | Superiority or Other |
| t-test, 2 sided | =0.0009 | Day 18 | Mean Difference (Final Values) | 5.9 | Standard Deviation | 18.0 | 2-Sided | 95 | 2.5 | 9.3 | Mean difference in degree of epithelialization [%] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only) | Superiority or Other |
| t-test, 2 sided | =0.0003 | Day 21 | Mean Difference (Final Values) | 5.6 | Standard Deviation | 15.8 | 2-Sided | 95 | 2.6 | 8.6 | Mean difference in degree of epithelialization [%] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only) | Superiority or Other |
| t-test, 2 sided | =0.0145 | Day 28 | Mean Difference (Final Values) | 3.6 | Standard Deviation | 15.1 | 2-Sided | 95 | 0.7 | 6.4 | Mean difference in degree of epithelialization [%] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only) | Superiority or Other |
| Oleogel-S10 more effective |
|
| Both treatments same efficacy |
|
| Standard of care (SOC) more effective |
|
| SOC much more effective |
|
| Wound half treated with wound dressing only |
|
| Both equal |
|
| Oleogel-S10 better tolerated |
|
| Both treatments equally well tolerated |
|
| SOC better tolerated |
|
| SOC much better tolerated |
|
| Samples without valid result |
|
| Title | Measurements |
|---|---|
|
| Related AEs |
|
| Application site reactions |
|
| Non treatment-emergent AEs |
|
| Title | Measurements |
|---|---|
|
| Life-Threatening (CTCAE Grade 4) |
|
| Death (CTCAE Grade 5) |
|
| Title | Measurements |
|---|---|
|
| Unknown relationship |
|
| No relationship |
|