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| Name | Class |
|---|---|
| A. Menarini Philippines, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kinerase | Experimental | Kinetin (N6-furfuryladenine) is an essential bio growth factor that regulates cell growth and is proven to delay and reverse the signs of aging. Kinerase has been found out to significantly improve the appearance of skin texture, mottled hyperpigmentation and fine wrinkles. It does not cause the cutaneous side effects that result from other commonly used anti-aging products. The Kinerase cream contains: Water, glyceryl stearate, propylene glycol, butylenes glycol, glycerin, cetyl alcohol, stearic acid, isopropyl palmitate, squalene, stearyl alcohol, glycene soja sterols, dimethicone, laureth-23, aloe barbadensis leaf juice, phenoxyethanol, carbomer, ethylhexyglycerin, sodium hydroxide, soluble collagen, kinetin, panthenol, tocopherol, citric acid, sodium citrate, hydrolysed elastin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kinetin, N6-furfuryladenine, 0.1% | Other |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin Roughness | Measured using Physician Evaluation and Patient Self-Evaluation of severity of cutaneous photoaging at baseline week, weeks 4, 8, and 12 | 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 | 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 | 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 | 12 weeks |
| Pores | Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8. | 12 weeks |
| Wrinkles | Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8. | 12 weeks |
| Texture | Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8. | 12 weeks |
| Porphyrins |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ma. Purita P. Lao, MD, FPDS | Makati Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Makati Medical Center | Makati City | National Capital Region | 1229 | Philippines | ||
| Makati Medical Center Department of Dermatology |
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| ID | Term |
|---|---|
| D007701 | Kinetin |
| ID | Term |
|---|---|
| D003583 | Cytokinins |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8. |
| 12 weeks |
| Visual Spots | Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8. | 12 weeks |
| UV spots | Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8. | 12 weeks |
| Brown Spots | Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8. | 12 weeks |
| Red Areas | Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8. | 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. | 12 weeks |
| Peeling | 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. | 12 weeks |
| Pruritus | 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. | 12 weeks |
| Dryness | 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. | 12 weeks |
| Edema | 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. | 12 weeks |
| Acne | 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. | 12 weeks |
| Makati City |
| NCR |
| 1229 |
| Philippines |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |