Clinical trial NCT01898182: Efficacy and Safety of Kinetin 0.1% for Treatment of Skin Photoaging
Official title: A Single Arm, Phase IV, Open-Label, Split-Face Trial to Evaluate the Efficacy and Safety of Kinetin, N6-furfuryladenine, 0.1% for Treatment of Cutaneous Photoaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cutaneous Photoaging
Lead sponsor: Makati Medical Center
Sponsor class: OTHER
Collaborators: name: A. Menarini Philippines, Inc.
First posted: 2013-07-12
Enrollment: 132
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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 subjects from dermatological clinics in a tertiary hospital in the Philippines for a period of 3 months (12 weeks). Changes in severity will be documented using physician evaluation, self-evaluation, and through VISIA complexion analysis system.

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 a tertiary hospital in the Philippines.

Patients from selected private dermatology clinics of a tertiary hospital will be screened and recruited to participate. They will be provided a written consent form (Appendix I) before they will be included in the study.

Following enrollment, subjects will return for outpatient visits at weeks 4, 8, and 12 for assessment.

The whole study will be conducted from July 2013 to November 2013. The first month would involve recruitment of patients. Qualified patients will start the 12-week treatment period and will be asked to follow up every 4 weeks. The last two months would be for data analysis, interpretation and writing of the scientific report.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Skin Roughness
timeFrame: 12 weeks
measure: Pigmentation
timeFrame: 12 weeks
measure: Fine wrinkles
timeFrame: 12 weeks
measure: Global Improvement in Cutaneous Photoaging
timeFrame: 12 weeks
measure: Pores
timeFrame: 12 weeks
measure: Wrinkles
timeFrame: 12 weeks
measure: Texture
timeFrame: 12 weeks
measure: Porphyrins
timeFrame: 12 weeks
measure: Visual Spots
timeFrame: 12 weeks
measure: UV spots
timeFrame: 12 weeks
measure: Brown Spots
timeFrame: 12 weeks
measure: Red Areas
timeFrame: 12 weeks
Secondary outcomes:
measure: Erythema
timeFrame: 12 weeks
measure: Burning
timeFrame: 12 weeks
measure: Peeling
timeFrame: 12 weeks
measure: Pruritus
timeFrame: 12 weeks
measure: Dryness
timeFrame: 12 weeks
measure: Edema
timeFrame: 12 weeks
measure: Acne
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Makati City
country: Philippines
facility: Makati Medical Center
state: Metro Manila
city: Makati City
country: Philippines
facility: Makati Medical Center Department of Dermatology
state: NCR
Study officials:
affiliation: Makati Medical Center
name: Ma. Purita P. Lao, MD, FPDS
role: PRINCIPAL_INVESTIGATOR
References: