This study is being conducted to provide a preliminary assessment of whether BL-5010 sloughs off SK lesions and has an acceptable safety profile (including no or minimal dermal irritation following the application at the site of the SK lesion).…
ID
Source
Brief title
Condition
- Cutaneous neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess whether BL-5010 is safe for use in patients with seborrheic keratosis
(SK)
Secondary outcome
To assess whether BL-5010 induces dermal irritation at the site of the
application of BL-5010
To determine whether BL-5010 completely removes the SK index lesion after one
or two applications of BL-5010
To assess the cosmetic outcome as assessed by the investigator and the patient
at the site of the sloughed-off index lesion
To determine the feasibility of histological examinations of the sloughed-off
index lesion
Background summary
TCA has been widely used as a peeling agent for the treatment of a number of
hyperkeratotic lesions, including seborrheic keratosis, actinic keratosis,
solar lentigines, and the signs of photoaging (Chun, 2004). TCA causes
coagulative necrosis of cells through extensive protein denaturation and
resultant structural cell death. Histologically, TCA peel results in the
eradication of solar elastosis, which is replaced by a thickened, homogenized
band of dermal collagen, which is complemented by cytologic and architectural
normalization of the epidermis.
Formic acid is a caustic acid used in the treatment of common warts and in
removal of nits from the scalp (Bhat, 2001). The exact mechanism of action of
formic acid is not known. It probably acts in a manner similar to formalin,
which destroys tissue by dehydration. After applying formic acid to warts, the
wart becomes slightly whitish in color and the superficial layer peels off,
indicating a keratolytic effect.
The anticipated method of action of combined TCA and FA is believed to cause
in-situ, in vivo fixation, preservation, and mummification of the lesion by
cross linking of the molecules and proteins thus causing slough off of the
lesion and potentially enables histolopathological examination and diagnosis.
In most cases this result will probably be achieved by a single application of
BL-5010, although some lesions may require two applications.
A practitioner applied a mixture of TCA, FA, and water to benign skin lesions
of patients and reported the following results. Twenty-seven patients with a
total of 55 lesions were treated. Most of the lesions were intradermal nevi
(IDN). All of the lesions sloughed off successfully. Ninety three (51/55)
lesions sloughed off after a single application of the mixture of TCA, FA, and
water. Six (11%) cases of hypopigmentation, 1 (2%) case of hyperpigmentation,
and 3 (5%) cases of superficial scarring occurred at the site of the index
lesion. Histopathological diagnosis could be performed on all sloughed off
lesions except for one that was lost.
BL-5010 is a new, liquid preparation with a proposed indication for the topical
treatment of benign lesions of the skin, such as Seborrheic Keratosis.
Seborrheic Keratosis (SK) occurs commonly in the older population and
frequently causes discomfort or is considered to be cosmetically disturbing.
Such lesions can be painful and also tend to become injured and sometimes bleed
and/or become infected.
At present, skin lesions that are not suspected to be malignant are treated by
methods such as cryotherapy, laser therapy, or electro-cauterization. Such
treatment often leads to complications that include pain, bleeding and
discharge, as well as infection, blistering, and hematoma. Such complications
often necessitate the application of localized antibiotics as well as
bandaging, are liable to cause further discomfort to the individual treated,
the healing process is liable to be slow and prolonged, and may lead to
scarring. Furthermore, cryotherapy, laser therapy, and electro-cauterization
destroy the treated skin region making histopathological diagnosis of the skin
lesions impossible.
BL-5010 is intended as a convenient treatment for removal of benign lesions of
the skin such as SK, which does not necessitate any antiseptic precautions or
local anesthesia. In addition the use of BL-5010 is intended to enable
histolopathological examination and diagnosis of the lesion, which is not
achievable with the use of cryotherapy, laser therapy or electro cauterization.
Study objective
This study is being conducted to provide a preliminary assessment of whether
BL-5010 sloughs off SK lesions and has an acceptable safety profile (including
no or minimal dermal irritation following the application at the site of the SK
lesion). Furthermore, if BL-5010 does slough off lesions, the cosmetic outcome
should be evaluated and, there is a need to provide data as to whether the
sloughed-off lesions can be used for histopathological diagnosis.
Study design
This will be an open-label, single-arm, safety and feasibility study of topical
application of BL-5010 to be conducted in up to 60 patients with seborrheic
keratosis. Patients will be enrolled into the study in stages. For the first
two stages, continued enrollment in the next stage will require approval by an
independent medical safety officer (IMSO). Two patients will be enrolled in
the first stage and, if the IMSO approves continued patient enrollment into the
study, an additional eight patients will be enrolled in the second stage. If
the IMSO approves continued patient enrollment into the study after the first
10 patients, 15 additional patients will be enrolled in the third stage. When
25 patients have been enrolled and have completed treatment with one or two
applications of BL-5010, an interim descriptive analysis will be conducted.
Based on the results of the interim analysis the sponsor may either continue to
enroll another 35 patients (total of 60 patients) in a fourth stage or
terminate the study.
Intervention
Each patient will receive up to two topical administrations of BL-5010 to one
SK lesion. The investigator will apply a titrated dose of BL 5010 to the one
SK lesion.
Study burden and risks
A burning sensation and dermal irritation at the site of application and
possible other local AE's. Following treatment slight changes in color, redness
or swelling at the site of application may be noticed. All acids have an
irritant effect on mucous membranes and therefore it should be avoided to have
contact of BL-5010 with eyes and mucous membranes e.g. lips, nostrils and ears.
In case of a brown skin caused by UV radiation, the skin may be subject to
changes in pigmentation (skin colour). Similarly, exposure to UV after
treatment may lead to post-inflammatory hypopigmentation (loss of skin colour)
or hyperpigmentation (darkening of the skin).
Keloid formation at the site of application may happen at a later stage after
completion of the study.
19 Hartum Street
91450 Jerusalem
IL
19 Hartum Street
91450 Jerusalem
IL
Listed location countries
Age
Inclusion criteria
Patients will be included in the study if they:
1. Are male or post menopausal female Caucasian patients between 18 to 85 years of age who can provide and have signed a written informed consent, and understand and comply with the requirements of the protocol
2. Have at least one SK lesion on the face (except for the first ten patients), scalp (only lesions that are not located within the hairline), trunk, or extremities that is 2.5 to 5 mm at its widest diameter and is not near the eye, nose, or mouth (e.g., investigator judges that the distance between the index lesion and either the eye, nose, or mouth is far enough to prevent BL 5010 causing irritation
Exclusion criteria
Patients will be excluded from the study if they have or meet any of the following criteria:
1. Have no individual SK lesions >2.5 mm that are not separated by at least 2 cm
2. Have no individual SK lesion but have only *collision lesions*
3. Have a history of keloid formation following surgical removal of skin lesions or other forms of dermal injury
4. Have any type of infection (e.g., methicillin-resistant staphylococcus aureus infection, etc.)
5. Are immunocomprised including all transplant patients or patients receiving any chemotherapy
6. Have a known diagnosis of Hepatitis B or C, or HIV
7. Have clinically significant unstable medical problems such as diabetes mellitus, clinically concerning cardiac arrhythmias, arteriosclerotic heart disease, renal insufficiency or failure, history of malignant melanoma, or history of cancer (excluding basal cell carcinoma) within the past 5 years prior to Screening
8. Have a clinically significant laboratory test in the 30-day interval prior to Screening such as a hemoglobin level below 10 gm/dL or an AST or ALT level greater than three times the upper limit of normal, etc.
9. Have been hospitalized for any medical condition within one month prior to Screening
10. Have used illicit drugs of abuse or have a history of alcohol abuse in the 3-month interval prior to Screening
11. Have been exposed to an investigational drug or device within 30 days prior to Screening or is scheduled to receive another investigational drug or device during either the Treatment Phase or Follow-up Evaluation
12. Have taken within the past 6 months or are currently taking any immunomodulatory drugs (e.g., ciclosporine, tacrolimus, etc.), biologic drugs (e.g., infliximab, Enbrel, etc.), or immunosuppressive drugs (e.g., azathioprine, corticosteroids, etc.) unless they have consented to an acceptable washout as follows:
• Systemic treatments (steroids, immune suppressants, etc.) - 1 month washout
• Exposure to ultra-violet light - 1 month washout
• Topical treatments (topical steroids, etc.) - 2 week washout
13. Are fertile men who are not willing to use an acceptable form of contraception. Where male patients have a female partner of childbearing potential, the female partner should use two different but effective forms of contraception.;Acceptable forms of effective contraception include:
• a. Established use of oral, injected or implanted hormonal methods of contraception
• b. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
• c. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
• d. Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate)
• e. True abstinence: When this is in line with the preferred and usual lifestyle of the patient;Males should use a barrier method during and for 3 months after their last dose of study drug, unless they are sterilized, in which case a period of 7 days can be applied.;For inclusion into the study female patients must:
• be postmenopausal for at least 1 year, OR
• have had a bilateral oopherectomy and/or hysterectomy, OR
• have had a bilateral tubal ligation or otherwise be incapable of
pregnancy;The following lesions cannot be used as the *index lesion*:
1. Actinic keratosis, warts, condylomata acuminatum, or molluscum contagiosum
2. Skin lesions such as dysplastic nevi, Spitz nevi, etc.
3. Scalp lesions within the hairline
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-006890-34-NL |
| CCMO | NL25870.078.08 |