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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002863-88 | EudraCT Number |
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The purpose of this trial is to evaluate the safety of a simultaneous treatment regimen compared to a sequential treatment regimen when two separate areas with AKs (one located on face/scalp and the other located on trunk/ extremities) are treated with ingenol mebutate gel
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ingenol mebutate gel 0.05 % | Active Comparator |
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| Ingenol mebutate gel 0.015 % | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ingenol mebutate gel 0.05 % | Drug | Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities either applied simultaneously or sequentially |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite Local Skin Reaction (LSR) Score 3 Days After Treatment of Each Selected Treatment Area | Composite Local Skin Reaction (LSR) score 3 days after treatment of each selected treatment area in both treatment groups (simultaneous or sequential). The composite LSR score (0 to 24), reflecting the sum of the individual LSR grades (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration, grade 0 to 4), was calculated for each selected treatment area at each visit.The composite LSR score ranges from 0 (best possible outcome) to 24 (worst possible outcome). Both affected areas were calculated together "Per Arm". Each subject could contribute with up to 2 values (1 for each treated area). | 3 days after treatment of each selected treatment area |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment | Complete clearance of Actinic Keratosis lesions (AKs) analysed in each separate treatment area and presented by treatment regimen given as "percentage of participants" with complete AK clearance. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together "Per Arm" (e.g. "averaged"). |
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Inclusion Criteria:
Subjects must provide informed consent
Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on face or scalp
Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on trunk or extremities
Subjects at least 18 years of age
Female subjects must be of either:
Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion.
Exclusion Criteria:
Location of the selected treatment areas:
Prior treatment with ingenol mebutate gel on face/scalp and on trunk/extremities
Lesions in the selected treatment areas that have:
History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication
Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the selected treatment areas
Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety and efficacy during the course of the trial, as determined by the investigator's clinical judgment.
Anticipated need for hospitalisation or out-patient surgery during the first 15 days after the first trial medication application.
Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel
Presence of sunburn within the selected treatment areas
Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial
Subjects previously randomised in the trial
Female subjects who are breastfeeding
In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol
Prohibited Therapies and/or Medications within 2 weeks prior to Visit 1:
Prohibited Therapies and/or Medications: within 4 weeks prior to Visit 1:
Prohibited Therapies and/or Medications within 8 weeks prior to Visit 1:
- Treatment with 5-fluorouracil (5-FU), imiquimod, topical diclofenac sodium, or photodynamic therapy within 2 cm of the selected treatment areas.
Prohibited Therapies and/or Medications within 6 months prior to Visit 1:
- Use of systemic retinoids or biologic/monoclonal antibody therapies
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Dermatologica dell'Università di Modena e Reggio Emilia | Modena | 41124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26300464 | Derived | Pellacani G, Peris K, Guillen C, Clonier F, Larsson T, Venkata R, Puig S. A randomized trial comparing simultaneous vs. sequential field treatment of actinic keratosis with ingenol mebutate on two separate areas of the head and body. J Eur Acad Dermatol Venereol. 2015 Nov;29(11):2192-8. doi: 10.1111/jdv.13211. Epub 2015 Aug 24. |
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In the clinical study protocol 200 subjects were planned to be enrolled and 199 subjects were actually enrolled and randomised.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ingenol Mebutate Gel Simultaneous Treatment | Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Ingenol mebutate gel 0.015 % | Drug | Ingenol mebutate gel 0.015 % (Picato®) on face/scalp either applied simultaneously or sequentially |
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| 8 weeks after treatment |
| Partial Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment | Partial clearance of Actinic Keratosis lesions (AKs) defined as 75% or greater reduction in Actinic Keratosis lesions (AKs) from start of treatment to 8 weeks after treatment, was analysed in each separate treatment area and presented by treatment regimen given as "percentage of participatns" with complete AK clearance. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together "Per Arm" (e.g. "averaged"). | 8 weeks after treatment |
| Percent Reduction in Number of AKs in Each Separate Treatment Area 8 Weeks After Treatment | Percent reduction in number of Actinic Keratosis lesions (AKs) analysed for each separate treatment area and presented by treatment regimen. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together "Per Arm" (e.g. "averaged"). | 8 weeks after treatment |
| Effectiveness Satisfaction Questionnaire for Medication (TSQM) | Effectiveness TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived effectiveness of medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome). | 8 weeks |
| Side Effects TSQM | Side Effects TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived side effects of medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome). | 8 weeks |
| Global Satisfaction TSQM | Global Satisfaction TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived overall satisfaction with medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome). | 8 weeks |
| Convenience TSQM | Convenience TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived convenience with medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome). | 8 weeks |
| FG001 |
| Ingenol Mebutate Gel Sequential Treatment |
Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ingenol Mebutate Gel Simultaneous Treatment | Ingenol mebutate gel 0.05 %: Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities applied simultaneously Ingenol mebutate gel 0.015 %: Ingenol mebutate gel 0.015 % (Picato®) on face/scalp applied simultaneously |
| BG001 | Ingenol Mebutate Gel Sequential Treatment | Ingenol mebutate gel 0.05 %: Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities applied sequentially Ingenol mebutate gel 0.015 %: Ingenol mebutate gel 0.015 % (Picato®) on face/scalp applied sequentially |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Composite Local Skin Reaction (LSR) Score 3 Days After Treatment of Each Selected Treatment Area | Composite Local Skin Reaction (LSR) score 3 days after treatment of each selected treatment area in both treatment groups (simultaneous or sequential). The composite LSR score (0 to 24), reflecting the sum of the individual LSR grades (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration, grade 0 to 4), was calculated for each selected treatment area at each visit.The composite LSR score ranges from 0 (best possible outcome) to 24 (worst possible outcome). Both affected areas were calculated together "Per Arm". Each subject could contribute with up to 2 values (1 for each treated area). | Posted | Mean | Standard Deviation | units on a scale | 3 days after treatment of each selected treatment area |
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| Secondary | Complete Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment | Complete clearance of Actinic Keratosis lesions (AKs) analysed in each separate treatment area and presented by treatment regimen given as "percentage of participants" with complete AK clearance. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together "Per Arm" (e.g. "averaged"). | Posted | Number | percentage of participants | 8 weeks after treatment |
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| Secondary | Partial Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment | Partial clearance of Actinic Keratosis lesions (AKs) defined as 75% or greater reduction in Actinic Keratosis lesions (AKs) from start of treatment to 8 weeks after treatment, was analysed in each separate treatment area and presented by treatment regimen given as "percentage of participatns" with complete AK clearance. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together "Per Arm" (e.g. "averaged"). | Posted | Number | percentage of participants | 8 weeks after treatment |
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| Secondary | Percent Reduction in Number of AKs in Each Separate Treatment Area 8 Weeks After Treatment | Percent reduction in number of Actinic Keratosis lesions (AKs) analysed for each separate treatment area and presented by treatment regimen. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together "Per Arm" (e.g. "averaged"). | Posted | Mean | Standard Deviation | percentage reduction in number of AKs | 8 weeks after treatment |
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| Secondary | Effectiveness Satisfaction Questionnaire for Medication (TSQM) | Effectiveness TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived effectiveness of medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome). | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | Side Effects TSQM | Side Effects TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived side effects of medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome). | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | Global Satisfaction TSQM | Global Satisfaction TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived overall satisfaction with medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome). | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| Secondary | Convenience TSQM | Convenience TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived convenience with medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome). | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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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 Simultaneous Treatment | Ingenol mebutate gel in 2 doses (0.015% and 0.05%) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. | 3 | 101 | 22 | 101 | ||
| EG001 | Ingenol Mebutate Gel Sequential Treatment | Ingenol mebutate gel in 2 doses (0.015% and 0.05%) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. | 4 | 98 | 22 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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| Skin ulcer | Skin and subcutaneous tissue disorders |
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| Benign renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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| Hyperglycaemia | Metabolism and nutrition disorders |
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| Haemorrhagic erosive gastritis | Gastrointestinal disorders |
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| Amnesia | Nervous system disorders |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pruritus | General disorders |
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| Application site pain | General disorders |
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| Feeling cold | General disorders |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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| Headache | Nervous system disorders |
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| Loss of consciousness | Nervous system disorders |
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| Conjunctivitis | Eye disorders |
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| Eyelid oedema | Eye disorders |
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| Scotoma | Eye disorders |
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| Bronchitis | Infections and infestations |
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| Urinary tract infection | Infections and infestations |
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| Application site burn | Injury, poisoning and procedural complications |
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| Fall | Injury, poisoning and procedural complications |
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| Actinic keratosis | Skin and subcutaneous tissue disorders |
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| Rash | Skin and subcutaneous tissue disorders |
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| Subcutaneous nodule | Skin and subcutaneous tissue disorders |
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| Vertigo | Ear and labyrinth disorders |
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| Depression | Psychiatric disorders |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders |
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| Hypertension | Vascular disorders |
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| Hyperglycaemia | Metabolism and nutrition disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical trial disclosure manager | LEO Pharma A/S | 00 45 44 94 58 88 | ctr.disclosure@leopharma.com |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C486592 | 3-ingenyl angelate |
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| >=65 years |
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| Male |
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| Spain |
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