Efficacy and Safety of Kinetin 0.1% for Treatment of Skin Photoaging

Makati Medical Center132 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

132

Conditions

Cutaneous Photoaging

Interventions

Kinetin, N6-furfuryladenine, 0.1%OTHER

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Makati Medical Center

Makati City, National Capital Region, Philippines

Makati Medical Center Department of Dermatology

Makati City, NCR, Philippines

Outcomes

Primary Outcomes

Skin Roughness

Measured using Physician Evaluation and Patient Self-Evaluation of severity of cutaneous photoaging at baseline week, weeks 4, 8, and 12

Time frame: 12 weeks

Pigmentation

Also called Mottling or Blotchiness. This is measured using Physician Evaluation and Patient Self-Evaluation of severity of cutaneous photoaging at baseline week, weeks 4, 8, and 12

Time frame: 12 weeks

Fine wrinkles

Measured using Physician Evaluation and Patient Self-Evaluation of severity of cutaneous photoaging at baseline week, weeks 4, 8, and 12

Time frame: 12 weeks

Global Improvement in Cutaneous Photoaging

Measured using Physician Evaluation and Patient Self-Evaluation of severity of cutaneous photoaging at baseline week, weeks 4, 8, and 12

Time frame: 12 weeks

Pores

Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.

Time frame: 12 weeks

Wrinkles

Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.

Time frame: 12 weeks

Texture

Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.

Time frame: 12 weeks

Porphyrins

Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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Secondary Outcomes

Erythema

An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a test product and which does not necessarily have a casual relationship with this treatment (ICH-GCP definition). In this study, all untoward medical occurrences will be collected irrespective whether the subject has taken any study product or not.

Time frame: 12 weeks

Burning

Also includes stinging. An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a test product and which does not necessarily have a casual relationship with this treatment (ICH-GCP definition). In this study, all untoward medical occurrences will be collected irrespective whether the subject has taken any study product or not.

Time frame: 12 weeks

Peeling

Time frame: 12 weeks

Pruritus

Time frame: 12 weeks

Dryness

Time frame: 12 weeks

Edema

Time frame: 12 weeks

Acne

Time frame: 12 weeks