Actinic KeratosisNCT03508856
Clinical and Histologic Evaluation of Picato 0.15% Gel in the Cosmetic Improvement of Photoaged Skin
A study testing Ingenol Mebutate (Picato®) 0.015% gel in people with Actinic Keratosis and Photo-aged Skin, run by Skin Laser & Surgery Specialists.
Trial summary
Clinical Evaluation: Subjects having actinic keratoses and meeting Glogau Photoaging Class III or IV complete the FDA approved 3 day course of Picato® 0.015% gel as approved for the treatment of facial Actinic Keratosis. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Actinic Keratosis, Photo-aged Skin
- What is being tested?
- Ingenol Mebutate (Picato®) 0.015% gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 9 Nov 2015to 9 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be adults aged 45-75 years of age.
- Subjects must be in good general health as confirmed by the medical history.
- Subjects must be able to read, sign, and understand the informed consent.
- Subjects must meet the criteris for Glogau Photoaging class III or class IV.
- Subjects have a diagnosis of actinic keratosis.
- Subjects must be willing to apply Picato 0.015% gel
- Subjects must be willing to forego any other treatments on the face, including cosmetic treatments, tanning bed use, and excessive sun exposure while enrolled in the study.
- If a subject is a female of childbearing potential she must have a urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study.
Who cannot join
- -. Subjects with a history of melanoma anywhere on the body.
- Subjects with any unstable medical condition as determined by the clinical investigator.
- Subjects with untreated non-melanoma skin cancer on the face or within the treatment area.
- Subjects with dermatitis or any dermatologic disease in the treatment area that would obscure the evaluation of photoaging parameters.
- Subjects who have undergone any form of 'field treatment' including 5-fluorouracil, photodynamic therapy, or ingenol mebutate in the preceeding six months.
- Women who are pregnant, lactating, or planning to become pregnant during the study period.
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- Subjects who have experienced a major medical event (including stroke, heart attack, etc) within 90 days of starting the study.
- Subjects who have active substance abuse disorders.
- Subjects who have known allergies to any components of the study drug.
- Subjects who are currently particpating in another clinical trial or who have completed a study involving laser, systemic, or topical treatment of the face within 30 days prior to study treatment initiation.
- Subjects who have received any of the following within 90 days prior to study treatment initiation:
- Interferon or interferon inducers
- Cytotoxic drugs
- Immunomodulators or immunosuppressive treatments (except inhaled or intranasal corticosteroids)
- Oral or parenteral corticosteroids
- Topical steroids to treatment area
- Any dermatologic procedures or surgeries to the treatment area, including cryosurgery for AKs
- Subjects who have used any topical prescription medications on the study area within 30 days prior to study treatment initiation
About this study
Clinical Evaluation:
Subjects having actinic keratoses and meeting Glogau Photoaging Class III or IV complete the FDA approved 3 day course of Picato® 0.015% gel as approved for the treatment of facial Actinic Keratosis. Each subject undergoes clinical multiple-angle standardized photographs on day 1, day 7, day 30, and day 60. Full face photography will be obtained with the medical research digital camera. Both subjects and investigators complete questionnaires at each visit with individual questions regarding improvement in actinic keratoses and overall skin appearance, wrinkling, dyschromia, erythema, and textural quality of skin. Each characteristic listed above will be graded on a 5 point scale ranging from 0 (lowest quality/worst appearance) to 5 (highest quality/best appearance). In addition, investigators will examine the subject's face and assign a numeric assessment on a 9 point scale ranging from 0 to 8 using previously published verified Griffiths' Photonumeric Photoaging scale. A second and third investigator will be presented at random blinded pretreatment (day 0) and posttreatment (day 60) photographs of each subject and be asked to assign a numerical value from Griffiths' Photonumeric Photoaging Scale. These blinded investgators will be given no information regarding which day each photograph represents. Comparison will be made of skin quality questionnaire scores from each visit and the pre and post treatment Griffiths' Photonumeric Grades.
Read more
The investigator opted against a split-face study design given the difficulty of blinding with this type of study as well as difficulty recruiting subjects willing to treat for two separate courses.
Histologic Evaluation:
Standard 3mm dermatology punch biopsies from clinically sun damaged skin will be taken. Biopsy will be taken from either the cosmetically acceptable pre-or infra-auricular area. A digital photograph will be taken and used to identify the pre-treatment biopsy site. Biopsies will be taken of 5 subjects before treatment and at day 60. Day 60 biopsies will be taken immediately adjacent to previously photographed and identified pre-treatment biopsies. Biopsies will be stained with hematoxylin and eosin and histologic features of pre and post treatment skin will be evaluated. Measurement of actinic keratoses, solar elastosis and overall epidermal and dermal thickness pre and post treatment will be compared.
- Conditions
- Actinic Keratosis, Photo-aged Skin
- Being tested
- Ingenol Mebutate (Picato®) 0.015% gel
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingenol Mebutate (Picato®) 0.015% gelDrug
| Study group | Role | What they receive |
|---|---|---|
| Picato 0.015% gel | Experimental | Picato 0.015% gel, is a topical treatment for actinic ketatoses. Receives: Drug: Ingenol Mebutate (Picato®) 0.015% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the improvement in actinic keratoses and photoaged skin as measured numerically by Griffiths' Photonumeric Photoaging scale and questionnaires,
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start9 Nov 2015
- Primary completion9 Aug 2016
- Study completion9 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skin Laser & Surgery Specialists
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma
- Responsible party
- Principal investigator, David J. Goldberg, MD, Skin Laser & Surgery Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508856
- Sponsor's protocol ID
- ENC_008776
- Status last verified
- Apr 2018
- First submitted
- 26 May 2016
- Last updated
- 26 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histologic Evaluation of Picato 0.15% Gel in the Cosmetic Improvement of Photoaged Skin
- ClinicalTrials.gov ID
- NCT03508856
- Acronym / sponsor ID
- ENC_008776
- Conditions
- Actinic Keratosis, Photo-aged Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Skin Laser & Surgery SpecialistsUniversity, hospital or other
- Collaborators
- LEO Pharma
- Study start
- 9 Nov 2015 (actual)
- Primary completion
- 9 Aug 2016 (actual)
- Study completion
- 9 Aug 2016 (actual)
- First posted
- 26 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Evaluation:
Subjects having actinic keratoses and meeting Glogau Photoaging Class III or IV complete the FDA approved 3 day course of Picato® 0.015% gel as approved for the treatment of facial Actinic Keratosis. Each subject undergoes clinical multiple-angle standardized photographs on day 1, day 7, day 30, and day 60. Full face photography will be obtained with the medical research digital camera. Both subjects and investigators complete questionnaires at each visit with individual questions regarding improvement in actinic keratoses and overall skin appearance, wrinkling, dyschromia, erythema, and textural quality of skin. Each characteristic listed above will be graded on a 5 point scale ranging from 0 (lowest quality/worst appearance) to 5 (highest quality/best appearance). In addition, investigators will examine the subject's face and assign a numeric assessment on a 9 point scale ranging from 0 to 8 using previously published verified Griffiths' Photonumeric Photoaging scale. A second and third investigator will be presented at random blinded pretreatment (day 0) and posttreatment (day 60) photographs of each subject and be asked to assign a numerical value from Griffiths' Photonumeric Photoaging Scale. These blinded investgators will be given no information regarding which day each photograph represents. Comparison will be made of skin quality questionnaire scores from each visit and the pre and post treatment Griffiths' Photonumeric Grades.
The investigator opted against a split-face study design given the difficulty of blinding with this type of study as well as difficulty recruiting subjects willing to treat for two separate courses.
Histologic Evaluation:
Standard 3mm dermatology punch biopsies from clinically sun damaged skin will be taken. Biopsy will be taken from either the cosmetically acceptable pre-or infra-auricular area. A digital photograph will be taken and used to identify the pre-treatment biopsy site. Biopsies will be taken of 5 subjects before treatment and at day 60. Day 60 biopsies will be taken immediately adjacent to previously photographed and identified pre-treatment biopsies. Biopsies will be stained with hematoxylin and eosin and histologic features of pre and post treatment skin will be evaluated. Measurement of actinic keratoses, solar elastosis and overall epidermal and dermal thickness pre and post treatment will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Picato 0.015% gel | Experimental | Drug: Ingenol Mebutate (Picato®) 0.015% gelPicato 0.015% gel, is a topical treatment for actinic ketatoses. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must be adults aged 45-75 years of age.
- Subjects must be in good general health as confirmed by the medical history.
- Subjects must be able to read, sign, and understand the informed consent.
- Subjects must meet the criteris for Glogau Photoaging class III or class IV.
- Subjects have a diagnosis of actinic keratosis.
Key exclusion criteria (18 listed)
- -. Subjects with a history of melanoma anywhere on the body.
- Subjects with any unstable medical condition as determined by the clinical investigator.
- Subjects with untreated non-melanoma skin cancer on the face or within the treatment area.
- Subjects with dermatitis or any dermatologic disease in the treatment area that would obscure the evaluation of photoaging parameters.
- Subjects who have undergone any form of 'field treatment' including 5-fluorouracil, photodynamic therapy, or ingenol mebutate in the preceeding six months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ingenol Mebutate (Picato®) 0.015% gel | Drug | Picato 0.015% gel |
Primary outcome
To evaluate the improvement in actinic keratoses and photoaged skin as measured numerically by Griffiths' Photonumeric Photoaging scale and questionnaires,
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ingenol Mebutate (Picato®) 0.015% gel in people with Actinic Keratosis and Photo-aged Skin, run by Skin Laser & Surgery Specialists.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the improvement in actinic keratoses and photoaged skin as measured numerically by Griffiths' Photonumeric Photoaging scale and questionnaires, (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.