Status:
COMPLETED
Efficacy and Safety of Kinetin 0.1% for Treatment of Skin Photoaging
Lead Sponsor:
Makati Medical Center
Collaborating Sponsors:
A. Menarini Philippines, Inc.
Conditions:
Cutaneous Photoaging
Eligibility:
FEMALE
35-65 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to evaluate the change in the severity and clinical signs of skin photoaging among Filipino patients using Kinerase cream (Kinetin 0.1%). This study will recruit 132 subjec...
Detailed Description
This study is a single-arm, open-label, split-face trial in subjects with mild to moderate photoaged facial skin. The study will enroll around 132 subjects from selected private dermatology clinics in...
Eligibility Criteria
Inclusion
- Filipino and Asian female subjects from private clinics of a tertiary hospital in the Philippines older than 35 years of age and less than 65 years of age.
- Subjects with mild to moderate cutaneous photoaging as assessed by the investigator's assessment 6-point scale.
- Subjects willing to sign an informed consent and adhere to all protocol requirements.
Exclusion
- Suspected porphyria, systemic or cutaneous lupus erythematosus, or any other photosensitizing disorder or drug-induced photosensitization
- Chronic or recurring skin disease or disorder
- Any active infectious skin disorder (Herpes simplex, molluscum contagiosum, and facial warts)
- Skin cancer of the facial tissues
- Any laser/IPL/ chemical peel in the 2 months preceding the screening visit
- History of Isotretinoin use, 6 months prior to the screening disease
- Topical tretinoin or adapalene in the 2 months prior to the screening visit
- Used topical alpha-hydroxy acid skincare products in the month preceding the screening visit
- On any anti-aging products and who wish to continue use of their products
- Requiring concurrent treatment that would interfere with the study assessments
- Pregnant or lactating females
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT01898182
Start Date
November 1 2013
End Date
September 1 2014
Last Update
September 15 2014
Active Locations (2)
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1
Makati Medical Center
Makati City, National Capital Region, Philippines, 1229
2
Makati Medical Center Department of Dermatology
Makati City, NCR, Philippines, 1229