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| Name | Class |
|---|---|
| LEO Pharma | INDUSTRY |
| Chonnam National University Hospital | OTHER |
| Severance Hospital | OTHER |
| Ajou University School of Medicine |
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This study evaluate the efficacy and safety of ingenol mebutate gel 0.015% on face and scalp & 0.05% on trunk and extremities in Korean patient with actinic keratosis.
The mechanism of action of ingenol mebutate for actinic keratosis(AK) treatment involves a rapid induction of necrosis followed by neutrophil-mediated, antibody-dependent cellular cytotoxicity (ADCC) of residual lesion. As the ingenol mebutate infiltrates the cell membrane, it increases intracellular Ca2+ concentration which leads to mitochondrial swelling and disruption of mitochondrial membrane within hours. The release of intra-mitochondrial Ca2+ into the cytoplasm leads to depletion of adenosine triphosphate (ATP) and a rapid induction of cell death by necrosis. This process occurs within 1 hour of application, which explains why the treatment period requires only 2 or 3 days of treatment. As the next phase, the cellular necrosis is accompanied by a robust inflammatory response through the release of proinflammatory cytokines from skin cells and tumor cells undergoing necrosis. The release of these proinflammatory cytokines into the dysplastic cells mediates the process of neutrophil recruitment through paracrine signaling and activation of endothelial cells. Here, the neutrophil mediated ADCC occurs, where activated neutrophils attach to the fragment, crystallized (Fc) parts of antibodies of dysplastic cells and destroys the residual dysplastic epidermal cells. In this way, the ingenol mebutate eradicates any residual tumor cells and prevents recurrence of actinic keratosis.As described above, the rapid effect and dual mechanism of action of ingenol mebutate gel allows not only a short-course therapy (2 or 3 days of application) for the elimination of actinic keratosis but also, the benefit for eradication of any residual lesions preventing the recurrence and the progression of AK into squamous cell carcinoma (SCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ingenol mebutate gel 0.015% | Active Comparator | Applied on face and scalp for three days. |
|
| ingenol mebutate gel 0.05% | Active Comparator | Applied on trunk and extremities for two days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ingenol mebutate gel 0.015% | Drug | -Face or Scalp arm (Referred to Face/Scalp arm): Apply ingenol mebutate gel 0.015% once daily for 3 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| CC Rate of AK Lesions in the Selected Treatment Area | Complete Clearance (CC) means that clearance of all visible AK lesions in the selected treatment area and Investigator-rated actinic keratiosis(AK) lesion complete clearance (CC) rate at the selected treatment area on day 57 was analyzed. | at day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change of the Number of AK Lesions in the Selected Treatment Area | Percentage change from baseline in the number of actinic keratiosis(AK) lesions in the selected treatment area on Day 57 was analyzed. | Baseline and Day 57 |
| Sustained CC Rate in CC Group |
| Measure | Description | Time Frame |
|---|---|---|
| Medication for Actinic Keratosis | The count of participants in complete clearance(CC) group and Non-CC group who administered medication for actinic keratosis on the selected treatment area after Day 57 was collected. | from 57 days to 6 months |
| Non-Drug Treatment/Surgery for Actinic Keratosis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilhwan Kim, MD | Korea University Ansan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Ansan-si | Gyeonggi-do | 15355 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9092763 | Result | Callen JP, Bickers DR, Moy RL. Actinic keratoses. J Am Acad Dermatol. 1997 Apr;36(4):650-3. doi: 10.1016/s0190-9622(97)70265-2. No abstract available. | |
| 22714759 | Result | Schmitt JV, Miot HA. Actinic keratosis: a clinical and epidemiological revision. An Bras Dermatol. 2012 May-Jun;87(3):425-34. doi: 10.1590/s0365-05962012000300012. |
| Label | URL |
|---|---|
| National Institute for Clinical Excellence. Guidance on Cancer Services:Improving outcomes for people with skin tumours including melanoma. The manual. February 2006. | View source |
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De-identified individual participant data for all primary and secondary outcome measures will be made within 6months of study completion.
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This study enrolled patients with actinic keratosis (AK) patients with the lesions on the face, scalp, trunk and/or extremities from 10 academic medical centers in South Korea. First subject was enrolled on 06 Apr 2015 and Last subject was completed on 13 Jun 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ingenol Mebutate Gel 0.015% | Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days. 1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area. |
| FG001 | Ingenol Mebutate Gel 0.05% | Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days. 1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Of 91 screened subjects, 77 subjects were enrolled and included in Safety Set (Face or Scalp Group: 67, Trunk or Extremities Group: 10). After excluding 4 subjects for missing primary efficacy assessment, 73 subjects (Face or Scalp Group: 64, Trunk or Extremities Group: 9) were included in ITT Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ingenol Mebutate Gel 0.015% | Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days. 1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 73 participants of overall number of baseline participants are analyzed as Intention To Treat (ITT) set. Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study and conducted the assessment of the primary efficacy measure. |
| 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 | CC Rate of AK Lesions in the Selected Treatment Area | Complete Clearance (CC) means that clearance of all visible AK lesions in the selected treatment area and Investigator-rated actinic keratiosis(AK) lesion complete clearance (CC) rate at the selected treatment area on day 57 was analyzed. | Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study). | Posted | Count of Participants | Participants | at day 57 |
|
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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 | Ingenol Mebutate Gel 0.015% | Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days. 1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Squamous cell carcinoma | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ilhwan Kim | Korea University Ansan Hospital | +82314125986 | kumcihk@korea.ac.kr |
Not provided
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| OTHER |
| Asan Medical Center | OTHER |
| Samsung Medical Center | OTHER |
| Seoul National University Bundang Hospital | OTHER |
| Dong-A University Hospital | OTHER |
| Korea University Anam Hospital | OTHER |
| Seoul National University Hospital | OTHER |
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|
| ingenol mebutate gel 0.05% | Drug | -Trunk or Extremities arm (Referred to Trunk/Extremities arm): Apply ingenol mebutate gel 0.05% once daily for 2 consecutive days |
|
|
Sustained Complete Clearance means that Complete Clearance was maintained until Month 6 in complete clearance (CC) group and sustained complete clearance(CC) rate at month 6 for complete clearance(CC) group was analyzed. |
| at 6 months |
| Recurrence Rate in CC Group | Recurrence rate in complete clearance(CC) group was analyzed. | at 6 months |
| Percentage Change of the Number of AK Lesions in the Selected Treatment Area of CC Group | Percentage change from baseline in the number of actinic keratiosis(AK) lesions at Month 6 in the selected treatment area in complete clearance(CC) Group was analyzed. | at 6 months from baseline |
| Change From Baseline in Quality of Life (Skindex-29) | Skindex-29 is a self-administered QoL questionnaire comprised of 29 items scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 items), symptomatic (7 items), and functional (12 items), with domain scores ranging from 0 to 40, 28, and 48, respectively. Lower scores for each of the domains represents a better Quality of life. | at 29 and 57 days from baseline |
| Treatment Satisfaction Questionnaire for Medication (TSQM) | Participants personally completed the tool to evaluate satisfaction with drug treatment. It consisted of 4 areas of Effectiveness, side effect, convenience, and global satisfaction, with a total of 14 sub-items. The full mark is 100, and it is divided in four stages as follows.
| at 29 and 57 days from baseline |
| Cosmetic Outcomes Assessment (COA) | The investigator rated the subject's Cosmetic Outcomes Assessment(COA) using 5 grades (Very good, Good, No change, Bad, Very bad), and results were as follows. | at 29 and 57 days from baseline |
| Time to Relapse in CC Group | Time to relapse in complete clearance(CC) Group was analyzed. Median survival time with 95% confidence interval was calculated by Kaplan-Meier method. | at 6 months |
The count of participants in complete clearance(CC) group and Non-CC group who received non-drug treatment/surgery for actinic keratosis on the selected treatment area after Day 57 was collected. |
| from 57 days to 6 months |
| 9627707 | Result | Brash DE, Ziegler A, Jonason AS, Simon JA, Kunala S, Leffell DJ. Sunlight and sunburn in human skin cancer: p53, apoptosis, and tumor promotion. J Investig Dermatol Symp Proc. 1996 Apr;1(2):136-42. |
| 23510990 | Result | Flohil SC, van der Leest RJ, Dowlatshahi EA, Hofman A, de Vries E, Nijsten T. Prevalence of actinic keratosis and its risk factors in the general population: the Rotterdam Study. J Invest Dermatol. 2013 Aug;133(8):1971-8. doi: 10.1038/jid.2013.134. Epub 2013 Mar 19. |
| 17822489 | Result | Rossi R, Mori M, Lotti T. Actinic keratosis. Int J Dermatol. 2007 Sep;46(9):895-904. doi: 10.1111/j.1365-4632.2007.03166.x. No abstract available. |
| 10607349 | Result | Salasche SJ. Epidemiology of actinic keratoses and squamous cell carcinoma. J Am Acad Dermatol. 2000 Jan;42(1 Pt 2):4-7. doi: 10.1067/mjd.2000.103342. |
| 20514316 | Result | Kim HS, Cho EA, Bae JM, Yu DS, Oh ST, Kang H, Park CJ, Lee JD, Lee JY, Kim SY, Kim HO, Park YM. Recent trend in the incidence of premalignant and malignant skin lesions in Korea between 1991 and 2006. J Korean Med Sci. 2010 Jun;25(6):924-9. doi: 10.3346/jkms.2010.25.6.924. Epub 2010 May 24. |
| 8918873 | Result | Slaper H, Velders GJ, Daniel JS, de Gruijl FR, van der Leun JC. Estimates of ozone depletion and skin cancer incidence to examine the Vienna Convention achievements. Nature. 1996 Nov 21;384(6606):256-8. doi: 10.1038/384256a0. |
| 21753882 | Result | Nelson CG. Diclofenac gel in the treatment of actinic keratoses. Ther Clin Risk Manag. 2011;7:207-11. doi: 10.2147/TCRM.S12498. Epub 2011 Jun 15. |
| 18955209 | Result | Stockfleth E, Ferrandiz C, Grob JJ, Leigh I, Pehamberger H, Kerl H; European Skin Academy. Development of a treatment algorithm for actinic keratoses: a European Consensus. Eur J Dermatol. 2008 Nov-Dec;18(6):651-9. doi: 10.1684/ejd.2008.0514. Epub 2008 Oct 27. |
| 19467365 | Result | Anderson L, Schmieder GJ, Werschler WP, Tschen EH, Ling MR, Stough DB, Katsamas J. Randomized, double-blind, double-dummy, vehicle-controlled study of ingenol mebutate gel 0.025% and 0.05% for actinic keratosis. J Am Acad Dermatol. 2009 Jun;60(6):934-43. doi: 10.1016/j.jaad.2009.01.008. |
| 24892649 | Result | Vegter S, Tolley K. A network meta-analysis of the relative efficacy of treatments for actinic keratosis of the face or scalp in Europe. PLoS One. 2014 Jun 3;9(6):e96829. doi: 10.1371/journal.pone.0096829. eCollection 2014. |
| 15097955 | Result | Lebwohl M, Dinehart S, Whiting D, Lee PK, Tawfik N, Jorizzo J, Lee JH, Fox TL. Imiquimod 5% cream for the treatment of actinic keratosis: results from two phase III, randomized, double-blind, parallel group, vehicle-controlled trials. J Am Acad Dermatol. 2004 May;50(5):714-21. doi: 10.1016/j.jaad.2003.12.010. |
| 22055282 | Result | Rosen RH, Gupta AK, Tyring SK. Dual mechanism of action of ingenol mebutate gel for topical treatment of actinic keratoses: rapid lesion necrosis followed by lesion-specific immune response. J Am Acad Dermatol. 2012 Mar;66(3):486-93. doi: 10.1016/j.jaad.2010.12.038. Epub 2011 Nov 4. |
| 22417254 | Result | Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012 Mar 15;366(11):1010-9. doi: 10.1056/NEJMoa1111170. |
| 23553119 | Result | Lebwohl M, Shumack S, Stein Gold L, Melgaard A, Larsson T, Tyring SK. Long-term follow-up study of ingenol mebutate gel for the treatment of actinic keratoses. JAMA Dermatol. 2013 Jun;149(6):666-70. doi: 10.1001/jamadermatol.2013.2766. |
| BG001 | Ingenol Mebutate Gel 0.05% | Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days. 1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 73 participants of overall number of baseline participants are analyzed as Intention To Treat (ITT) set. Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study and conducted the assessment of the primary efficacy measure. | Count of Participants | Participants |
|
| Fitzpatrick skin type | Fitzpatrick skin type was described as following; Type I: Extremely fair skin, always burns, never tans Type II: Fair skin, always burns, sometimes tans Type III: Medium skin, sometimes burns, always tans Type IV: Olive skin, rarely burns, always tans Type V: Moderately pigmented brown skin, never burns, always tans Type VI: Markedly pigmented black skin, never burns, always tans and it was considered worse outcomes from type IV upto type VI. | Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study). | Count of Participants | Participants |
|
| Height | Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study). | Mean | Standard Deviation | cm |
|
| Weight | Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study). | Mean | Standard Deviation | kg |
|
| BMI | Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study). | Mean | Standard Deviation | kg/m^2 |
|
| Actinic keratosis duration | Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study). | Mean | Standard Deviation | months |
|
| Actinic keratosis duration at the selected treatment area | Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study). | Mean | Standard Deviation | months |
|
| Severity of actinic keratosis | Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study). | Count of Participants | Participants |
|
| Prior treatment history of actinic keratosis | Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study). | Count of Participants | Participants |
|
| OG001 | Ingenol Mebutate Gel 0.05% | Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days. 1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area. |
|
|
| Secondary | Percentage Change of the Number of AK Lesions in the Selected Treatment Area | Percentage change from baseline in the number of actinic keratiosis(AK) lesions in the selected treatment area on Day 57 was analyzed. | Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study). | Posted | Mean | Standard Deviation | percentage change | Baseline and Day 57 |
|
|
|
| Secondary | Sustained CC Rate in CC Group | Sustained Complete Clearance means that Complete Clearance was maintained until Month 6 in complete clearance (CC) group and sustained complete clearance(CC) rate at month 6 for complete clearance(CC) group was analyzed. | In intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study), CC Group consisted of 54 participants who had at least 1 follow-up after achieving complete clearance of AK lesions on Day 57. | Posted | Count of Participants | Participants | at 6 months |
|
|
|
| Secondary | Recurrence Rate in CC Group | Recurrence rate in complete clearance(CC) group was analyzed. | In intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study), CC Group consisted of 54 participants who had at least 1 follow-up after achieving complete clearance of AK lesions on Day 57. | Posted | Count of Participants | Participants | at 6 months |
|
|
|
| Secondary | Percentage Change of the Number of AK Lesions in the Selected Treatment Area of CC Group | Percentage change from baseline in the number of actinic keratiosis(AK) lesions at Month 6 in the selected treatment area in complete clearance(CC) Group was analyzed. | In intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study), CC Group consisted of 54 participants who had at least 1 follow-up after achieving complete clearance of AK lesions on day 57. | Posted | Mean | Standard Deviation | Percentage change | at 6 months from baseline |
|
|
|
| Secondary | Change From Baseline in Quality of Life (Skindex-29) | Skindex-29 is a self-administered QoL questionnaire comprised of 29 items scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 items), symptomatic (7 items), and functional (12 items), with domain scores ranging from 0 to 40, 28, and 48, respectively. Lower scores for each of the domains represents a better Quality of life. | Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study). | Posted | Mean | Standard Deviation | units on a scale | at 29 and 57 days from baseline |
|
|
|
| Secondary | Treatment Satisfaction Questionnaire for Medication (TSQM) | Participants personally completed the tool to evaluate satisfaction with drug treatment. It consisted of 4 areas of Effectiveness, side effect, convenience, and global satisfaction, with a total of 14 sub-items. The full mark is 100, and it is divided in four stages as follows.
| Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study). | Posted | Mean | Standard Deviation | units on a scale | at 29 and 57 days from baseline |
|
|
|
| Secondary | Cosmetic Outcomes Assessment (COA) | The investigator rated the subject's Cosmetic Outcomes Assessment(COA) using 5 grades (Very good, Good, No change, Bad, Very bad), and results were as follows. | Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study). | Posted | Count of Participants | Participants | at 29 and 57 days from baseline |
|
|
|
| Secondary | Time to Relapse in CC Group | Time to relapse in complete clearance(CC) Group was analyzed. Median survival time with 95% confidence interval was calculated by Kaplan-Meier method. | CC Group consisted of 54 participants who had at least 1 follow-up after achieving Complete Clearance of AK lesions on Day 57. | Posted | Median | 95% Confidence Interval | days | at 6 months |
|
|
|
| Other Pre-specified | Medication for Actinic Keratosis | The count of participants in complete clearance(CC) group and Non-CC group who administered medication for actinic keratosis on the selected treatment area after Day 57 was collected. | The number of participants who had at least 1 follow-up after assessment of treatment response on Day 57 was 67 and which is consisit of CC group(54 participants) and Non-CC group(13 participants). The CC group and Non-CC group for Ingenol Mebutate Gel 0.015% and 0.05% were intended to be analyzed together. | Posted | Count of Participants | Participants | from 57 days to 6 months |
|
|
|
| Other Pre-specified | Non-Drug Treatment/Surgery for Actinic Keratosis | The count of participants in complete clearance(CC) group and Non-CC group who received non-drug treatment/surgery for actinic keratosis on the selected treatment area after Day 57 was collected. | The number of participants who had at least 1 follow-up after assessment of treatment response on Day 57 and which is consisit of CC group(54 participants) and Non-CC group(13 participants). The CC group /Non-CC group for Ingenol Mebutate Gel 0.015% and 0.05% were intended to be analyzed together. | Posted | Count of Participants | Participants | from 57 days to 6 months |
|
|
|
| 0 |
| 67 |
| 1 |
| 67 |
| 67 |
| 67 |
| EG001 | Ingenol Mebutate Gel 0.05% | Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days. 1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area. | 0 | 10 | 0 | 10 | 10 | 10 |
| Scab | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
|
| Skin swelling | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
|
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Systematic Assessment |
|
| Administration site pain | General disorders | MedDRA version 19.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA version 19.0 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA version 19.0 | Systematic Assessment |
|
| Ichthyosis | Congenital, familial and genetic disorders | MedDRA version 19.0 | Systematic Assessment |
|
| Wound secretion | Injury, poisoning and procedural complications | MedDRA version 19.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Systematic Assessment |
|
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| Emotions(Day 29) |
|
|
| Emotions(Day 57) |
|
|
| Emotions(Day 29-Baseline) |
|
|
| Emotions(Day 57-Baseline) |
|
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| Symptoms(Baseline) |
|
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| Symptoms(Day 29) |
|
|
| Symptoms(Day 57) |
|
|
| Symptoms(Day 29-Baseline) |
|
|
| Symptoms(Day 57-Baseline) |
|
|
| Functioning(Baseline) |
|
|
| Functioning(Day 29) |
|
|
| Functioning(Day 57) |
|
|
| Functioning(Day 29-Baseline) |
|
|
| Functioning(Day 57-Baseline) |
|
|
| Effectiveness(Day 57) |
|
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| Side-effect(Day 29) |
|
|
| Side-effect(Day 57) |
|
|
| Convenience(Day 29) |
|
|
| Convenience(Day 57) |
|
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| Global satisfaction(Day 29) |
|
|
| Global satisfaction(Day 57) |
|
|
| Good |
|
| No change |
|
| Bad |
|
| Very bad |
|
| Day 57 |
|
|
| Phototherapy |
|
| Skin lesion excision |
|
| Wound treatment |
|
| Biopsy skin |
|