Cutaneous Photoaging Clinical Trial
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
| Verified date | September 2014 |
| Source | Makati Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Philippines : Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 132 |
| Est. completion date | September 2014 |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 35 Years to 65 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| Philippines | Makati Medical Center | Makati City | Metro Manila |
| Philippines | Makati Medical Center Department of Dermatology | Makati City | NCR |
| Lead Sponsor | Collaborator |
|---|---|
| Makati Medical Center | A. Menarini Philippines, Inc. |
Philippines,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | Pores | Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8. | 12 weeks | No |
| Primary | Wrinkles | Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8. | 12 weeks | No |
| Primary | Texture | Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8. | 12 weeks | No |
| Primary | Porphyrins | Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8. | 12 weeks | No |
| Primary | Visual Spots | Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8. | 12 weeks | No |
| Primary | UV spots | Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8. | 12 weeks | No |
| Primary | Brown Spots | Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8. | 12 weeks | No |
| Primary | Red Areas | Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8. | 12 weeks | No |
| Secondary | 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 | Yes |
| Secondary | 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 | Yes |
| Secondary | 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 | Yes |
| Secondary | 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 | Yes |
| Secondary | 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 | Yes |
| Secondary | 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 | Yes |
| Secondary | 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 | Yes |