Status:
COMPLETED
Efficacy and Safety Study of Kinerase® for Treatment of Cutaneous Facial Photodamage
Lead Sponsor:
Menarini (Thailand) Limited
Conditions:
Skin Roughness
Mottling
Eligibility:
All Genders
35-65 years
Phase:
PHASE4
Brief Summary
The purpose of the K.I.S.S. study is to evaluate the efficacy of Kinerase® Cream (Kinetin 0.1%) in Thai patients, on the basis of the severity and clinical signs of facial photodamage.
Eligibility Criteria
Inclusion
- Male and female subjects older than 35 years of age and less than 65 years of age.
- Subjects with mild, moderate or severe facial photodamage as assessed by a 10-point scale.
- Subjects willing to sign an informed consent and adhere to all protocol requirements.
Exclusion
- Male and female subjects with suspected porphyria, systemic or cutaneous erythematosus lupus, or any other photosensitizing disorder or drug-induced photosensitization.
- Subjects with chronic or recurring skin disease or disorder.
- Subjects with any active infectious skin disorder (Herpes simplex, molluscum contagiosum, and facial warts).
- Subjects with skin cancer of the facial tissues.
- Subjects who have received any laser/ intense pulsed light (IPL) / chemical peel in the 2 months preceding the screening visit.
- Subjects with a history of topical and/or oral isotretinoin use, 6 months prior to the screening visit.
- Subjects who have been on topical Retin-A or Renova in the 2 months prior to the screening visit.
- Subjects who have used topical alpha-hydroxy acid skin care products in the month preceding the screening visit.
- Subjects currently on any anti-aging products and who wish to continue use of their products.
- Subjects requiring concurrent treatment that would interfere with the study assessments.
- Pregnant or lactating female subjects.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01885091
Start Date
December 1 2012
Last Update
June 25 2013
Active Locations (1)
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1
I-Sky Center Chidlom branch
Bangkok, Bangkok, Thailand, 10500