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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Makati Medical Center
Sponsor:
Collaborator:
A. Menarini Philippines, Inc.
Information provided by (Responsible Party):
Ma. Purita Paz-Lao, MD, FPDS, Makati Medical Center
ClinicalTrials.gov Identifier:
NCT01898182
First received: July 3, 2013
Last updated: May 25, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Cutaneous Photoaging
Other: Kinetin, N6-furfuryladenine, 0.1%
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Makati Medical Center:

Primary Outcome Measures:
  • Skin Roughness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measured using Physician Evaluation and Patient Self-Evaluation of severity of cutaneous photoaging at baseline week, weeks 4, 8, and 12

  • Pigmentation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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

  • Fine wrinkles [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measured using Physician Evaluation and Patient Self-Evaluation of severity of cutaneous photoaging at baseline week, weeks 4, 8, and 12

  • Global Improvement in Cutaneous Photoaging [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measured using Physician Evaluation and Patient Self-Evaluation of severity of cutaneous photoaging at baseline week, weeks 4, 8, and 12

  • Pores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.

  • Wrinkles [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.

  • Texture [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.

  • Porphyrins [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.

  • Visual Spots [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.

  • UV spots [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.

  • Brown Spots [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.

  • Red Areas [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.


Secondary Outcome Measures:
  • Erythema [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Burning [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Peeling [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Pruritus [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Dryness [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Edema [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Acne [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 132
Study Start Date: November 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kinerase
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.
Other: Kinetin, N6-furfuryladenine, 0.1%
Other Name: Kinerase cream

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

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01898182

Contacts
Contact: Ma. Purita P. Lao, MD, FPDS +6328888999 ext 2120 ppazlao@yahoo.com

Locations
Philippines
Makati Medical Center Not yet recruiting
Makati City, Metro Manila, Philippines, 1229
Contact: Ma. Purita P. Lao, MD, FPDS    +6328888999 ext 2120    ppazlao@yahoo.com   
Principal Investigator: Ma. Purita P. Lao, MD, FPDS         
Makati Medical Center Department of Dermatology Recruiting
Makati City, NCR, Philippines, 1229
Contact: Ma. Purita P. Lao, MD, FPDS    +632-8888999 ext 2120    ppazlao@yahoo.com   
Contact: Jamaine Melisse L. Cruz, MD    +63888999 ext 2220    jamainecruz@gmail.com   
Principal Investigator: Ma. Purita P. Lao, MD, FPDS         
Sub-Investigator: Jamaine Melisse L. Cruz, MD         
Sponsors and Collaborators
Makati Medical Center
A. Menarini Philippines, Inc.
Investigators
Principal Investigator: Ma. Purita P. Lao, MD, FPDS Makati Medical Center
  More Information

No publications provided

Responsible Party: Ma. Purita Paz-Lao, MD, FPDS, Chairman, Makati Medical Center
ClinicalTrials.gov Identifier: NCT01898182     History of Changes
Other Study ID Numbers: MMCDeptofDerma-Kinerase-2013
Study First Received: July 3, 2013
Last Updated: May 25, 2014
Health Authority: Philippines : Food and Drug Administration

Additional relevant MeSH terms:
Skin Diseases
Kinetin
Plant Growth Regulators
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014