Pharmacokinetics of LEO 43204 Gel in Actinic Keratosis Administered Under Maximal Use Conditions
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2015 |
| End Date: | July 2015 |
This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel
groups will be enrolled. The trial includes three active treatment groups. To be eligible
for inclusion in this trial, subjects must have at least 15 clinically typical, visible, and
discrete actinic keratosis (AKs) on the face, scalp or on the arm within a contiguous area
of approximately 250 cm2 of sun-damaged skin.
There will be 3 treatment groups: (1) once daily application of LEO43204 gel 0.018% on the
full face for three consecutive days, (2) once daily application of LEO43204 gel 0.1% on the
arm on a treatment area of approximately 250 cm2 for three consecutive days and , (3) once
daily application of LEO43204 gel 0.037 % on the scalp for three consecutive days.
groups will be enrolled. The trial includes three active treatment groups. To be eligible
for inclusion in this trial, subjects must have at least 15 clinically typical, visible, and
discrete actinic keratosis (AKs) on the face, scalp or on the arm within a contiguous area
of approximately 250 cm2 of sun-damaged skin.
There will be 3 treatment groups: (1) once daily application of LEO43204 gel 0.018% on the
full face for three consecutive days, (2) once daily application of LEO43204 gel 0.1% on the
arm on a treatment area of approximately 250 cm2 for three consecutive days and , (3) once
daily application of LEO43204 gel 0.037 % on the scalp for three consecutive days.
Inclusion Criteria:
1. Subjects with 15 or more clinically typical, visible and discrete AKs on either:
- Full face (corresponding to a treatment area of at least 250 cm2). If subjects
have a beard they must shave no later than the day before the first drug
application.
- A contiguous area of approximately 250 cm2 on the arm between wrist and
shoulder.
- Balding scalp (corresponding to a treatment area of approximately 250 cm2).
Subjects with sparse hair on the scalp can be enrolled as long as LSR and AK
assessments are not compromised.
2. Subject at least 18 years of age.
3. Female subjects of childbearing potential* must be confirmed not pregnant by a
negative urine pregnancy test prior to trial treatment.
4. Female subjects of childbearing potential must be willing to use effective
contraception at trial entry and until completion.
Exclusion Criteria:
1. Location of the treatment area (full face, full balding scalp, chest, trunk or
extremities)
- within 5 cm of an incompletely healed wound.
- within 5 cm of a suspected basal cell carcinoma (BCC) or SCC.
2. Previously assigned treatment in this clinical trial or previously participated in a
clinical trial in the LEO 43204 programme.
3. Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous
horns)and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two
previous occasions).
We found this trial at
1
site
Click here to add this to my saved trials
