Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/28/2013 |
| Start Date: | March 2013 |
| End Date: | March 2014 |
| Contact: | Shelbi Jim On, MD |
| Email: | shelbi.jimon@mountsinai.org |
| Phone: | 212-241-3288 |
An Investigator-Initiated Study to Assess the Degree of Irritation After a Second Cycle of Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp
Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet
radiation exposure. While most authorities consider AK as a pre-malignant lesion, some
consider it as an incipient squamous cell carcinoma (SCC). Among the current therapies for
the treatment of AK are excisional surgery, cryosurgery, electrodesiccation and curettage,
topical chemotherapy and light therapies. Cryosurgery is considered the gold standard for
therapy, however as with other lesion-directed therapies, cryosurgery does not treat
subclinical lesions in the surrounding skin. Ingenol mebutate is the active compound in the
sap from Euphorbia peplus L. (E. peplus). Topical ingenol mebutate treatment has been
approved for the treatment of AKs. The goal of AK therapy for all physicians is to provide
an effective, tissue-sparing treatment with good cosmetic results. Ingenol mebutate gel
0.015% has shown to not only have a high clearance rate but also a transient localized
inflammatory skin response that resolves quickly without sequelae. However, one common fear
about ingenol mebutate is that it's mechanism of action is purely destructive to both AKs
and healthy skin, and that retreatment would produce an equally, if not more, caustic result
on the skin such as severe erosion, scaling, and erythema. It is our hope to debunk this
misconception and demonstrate that reapplication of a second cycle of ingenol mebutate would
result in lower LSR scores compared to the LSR in the first cycle of application. We plan to
treat 20 subjects. Each qualifying subject will have at least 4-8 non-hypertrophic AKs in a
25 cm2 treatment area on the face or scalp. All subjects will be treated with two cycles of
ingenol mebutate 0.015%. The first cycle will be started on Day 1, and the second cycle will
be started on Day 29 (four weeks apart). Subjects will utilize the once daily for three days
regimen for both cycles.
radiation exposure. While most authorities consider AK as a pre-malignant lesion, some
consider it as an incipient squamous cell carcinoma (SCC). Among the current therapies for
the treatment of AK are excisional surgery, cryosurgery, electrodesiccation and curettage,
topical chemotherapy and light therapies. Cryosurgery is considered the gold standard for
therapy, however as with other lesion-directed therapies, cryosurgery does not treat
subclinical lesions in the surrounding skin. Ingenol mebutate is the active compound in the
sap from Euphorbia peplus L. (E. peplus). Topical ingenol mebutate treatment has been
approved for the treatment of AKs. The goal of AK therapy for all physicians is to provide
an effective, tissue-sparing treatment with good cosmetic results. Ingenol mebutate gel
0.015% has shown to not only have a high clearance rate but also a transient localized
inflammatory skin response that resolves quickly without sequelae. However, one common fear
about ingenol mebutate is that it's mechanism of action is purely destructive to both AKs
and healthy skin, and that retreatment would produce an equally, if not more, caustic result
on the skin such as severe erosion, scaling, and erythema. It is our hope to debunk this
misconception and demonstrate that reapplication of a second cycle of ingenol mebutate would
result in lower LSR scores compared to the LSR in the first cycle of application. We plan to
treat 20 subjects. Each qualifying subject will have at least 4-8 non-hypertrophic AKs in a
25 cm2 treatment area on the face or scalp. All subjects will be treated with two cycles of
ingenol mebutate 0.015%. The first cycle will be started on Day 1, and the second cycle will
be started on Day 29 (four weeks apart). Subjects will utilize the once daily for three days
regimen for both cycles.
We plan to treat 20 subjects. Each qualifying subject will have at least 4-8
non-hypertrophic AKs in a 25 cm2 treatment area on the face or scalp. All subjects will be
treated with two cycles of ingenol mebutate 0.015%. The first cycle will be started on Day
1, and the second cycle will be started on Day 29 (four weeks apart). Subjects will utilize
the once daily for three days regimen for both cycles. For the first cycle of study
application, subjects will be followed on day 1, day 2, and day 4 during treatment; on day 1
baseline photographs will be taken, on day 2 LSR will be assessed and visual analog scale
(VAS) regarding perceived irritation will be conducted, and on day 4 LSR, VAS and
photographs will be taken. Post-treatment follow-up will be conducted on day 8 and day 15,
in which LSR will be assessed and photographs taken. Approximately four weeks later, a
second cycle of once daily for three day regimen of ingenol mebutate 0.015% will be applied
to the same treatment area on the face or scalp. Subjects will be followed during treatment
on day 29, day 30 and day 32; on day 29 LSR and photographs will be taken, on day 30 LSR
will be assessed and VAS conducted, and on day 32 LSR, VAS and photographs will be taken.
Post-treatment follow-up for the second cycle of application will occur on day 36, day 43,
and day 56. During these post-treatment follow-up visits LSR and photographs will be taken.
LSR scores from day 4 and day 32 will be assessed by a blinded observer. Lastly, on day 29
and day 56 the patient's treatment satisfaction will be evaluated on a 10 point visual
analog scale (VAS). Consequently, there will be a total of 11 visits during a 56 day period.
non-hypertrophic AKs in a 25 cm2 treatment area on the face or scalp. All subjects will be
treated with two cycles of ingenol mebutate 0.015%. The first cycle will be started on Day
1, and the second cycle will be started on Day 29 (four weeks apart). Subjects will utilize
the once daily for three days regimen for both cycles. For the first cycle of study
application, subjects will be followed on day 1, day 2, and day 4 during treatment; on day 1
baseline photographs will be taken, on day 2 LSR will be assessed and visual analog scale
(VAS) regarding perceived irritation will be conducted, and on day 4 LSR, VAS and
photographs will be taken. Post-treatment follow-up will be conducted on day 8 and day 15,
in which LSR will be assessed and photographs taken. Approximately four weeks later, a
second cycle of once daily for three day regimen of ingenol mebutate 0.015% will be applied
to the same treatment area on the face or scalp. Subjects will be followed during treatment
on day 29, day 30 and day 32; on day 29 LSR and photographs will be taken, on day 30 LSR
will be assessed and VAS conducted, and on day 32 LSR, VAS and photographs will be taken.
Post-treatment follow-up for the second cycle of application will occur on day 36, day 43,
and day 56. During these post-treatment follow-up visits LSR and photographs will be taken.
LSR scores from day 4 and day 32 will be assessed by a blinded observer. Lastly, on day 29
and day 56 the patient's treatment satisfaction will be evaluated on a 10 point visual
analog scale (VAS). Consequently, there will be a total of 11 visits during a 56 day period.
Inclusion Criteria:
- Adults at least 18 years old.
- 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 have at least 4-8 clinically typical, visible, non-hypertrophic actinic
keratoses on the face or scalp in a 25 cm2 area.
- Subject must be willing to forego any other treatments on the face or scalp,
including tanning bed use and excessive sun exposure while in the study.
- Subject is willing and able to participate in the study as an outpatient, making
frequent visits to the study center during the treatment and follow-up periods and to
comply with all study requirements including concomitant medication and other
treatment restrictions.
- If subject is a female of childbearing potential she must have a negative 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.
Exclusion Criteria:
- Subjects with a history of melanoma anywhere on the body.
- The second cycle of ingenol mebutate 0.015% should only be applied if the skin is
healed from the first cycle of ingenol mebutate 0.015%.
- Subjects with an unstable medical condition as deemed by the clinical investigator.
- Subjects with non-melanoma skin cancer on the face or scalp.
- Subjects with any dermatologic disease in the treatment area that may be exacerbated
by the treatment proposed or that might impair the evaluation of AKs.
- Subjects who have previously been treated with ingenol mebutate: on the face or scalp
in the past 6 months; or outside of the study area within the past 30 days.
- Women who are pregnant, lactating, or planning to become pregnant during the study
period.
- Subjects who have experienced a clinically important medical event within 90 days of
the visit (e.g., stroke, myocardial infarction, etc).
- Subjects who have active chemical dependency or alcoholism as assessed by the
investigator.
- Subjects who have known allergies to any excipient in the study gel.
- Subjects who are currently participating in another clinical study or have completed
another clinical study with an investigational drug or device on the study area
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 therapies (inhaled/ intranasal steroids
are permitted)
- oral or parenteral corticosteroids
- topical corticosteroids if greater than 2 gm/day
- any dermatologic procedures or surgeries on the study area (including any AK
treatments)
- Subjects who have used any topical prescription medications on the study area within
30 days prior to study treatment initiation.
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