Status:
COMPLETED
Tolerability and Bioavailability of the P144 Peptide Inhibitor of TGF-β1 After Topical Administration in Healthy Volunteers
Lead Sponsor:
ISDIN
Collaborating Sponsors:
Digna Biotech S.L.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Transforming growth factor-beta 1 (TGF-β1) is consistently over expressed in most fibrotic diseases and displays a variety of profibrotic effects in fibroblasts. Activation of TGF-β receptors induces ...
Detailed Description
Three different formulations of DIGNA P144 cream (containing 100 μg/mL, 200 μg/mL and 300 μg/mL) will be tested in healthy volunteers. Tolerability evaluation is performed through the specific cutaneo...
Eligibility Criteria
Inclusion
- Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.
- Age between 18 and 45 years old
- Skin phenotype I to IV following Fitzpatrick's classification scale
- BMI between 20-29 kg/sqm
- Not clinically relevant alterations in: arterial pressure, cardiac frequency, analytical values (Hematology, Biochemistry, Urianalysis, Coagulation, Serology, Toxics)
Exclusion
- Pregnany or lactancy
- Allergy to any medication
- Subjects with skin illnesses or systemic illnesses with skin afectation
- History of drug abuse or regular consumption of alcohol
- Participation in other clinical trials 3 months before the signature of the informed consent
- UV exposure or sun exposure on the zone to be treated
- History of skin hypersensitivity
- Chronic treatment with anti-inflammatories or anti-histaminics
- Treatment with corticoids on the previous month
- Hyperpigmentation on the zone to be treated
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00656825
Start Date
March 1 2007
End Date
June 1 2007
Last Update
November 5 2008
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario Puerta de Hierro
Madrid, Madrid, Spain, 28035
2
Clínica Universitaria de Navarra
Pamplona, Pamplona, Spain, 31008