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Completed

NCT Number: NCT01898182

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

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.

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Key information

Conditions

Cutaneous Photoaging

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Makati Medical Center Department of Dermatology, Makati City, NCR, Philippines

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kinetin, N6-furfuryladenine, 0.1%

Other

Other names: Kinerase cream

Primary outcomes

  1. Skin Roughness

    Time frame: 12 weeks

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

  2. Pigmentation

    Time frame: 12 weeks

    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

  3. Fine wrinkles

    Time frame: 12 weeks

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

  4. Global Improvement in Cutaneous Photoaging

    Time frame: 12 weeks

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

  5. Pores

    Time frame: 12 weeks

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

  6. Wrinkles

    Time frame: 12 weeks

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

  7. Texture

    Time frame: 12 weeks

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

  8. Porphyrins

    Time frame: 12 weeks

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

  9. Visual Spots

    Time frame: 12 weeks

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

  10. UV spots

    Time frame: 12 weeks

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

  11. Brown Spots

    Time frame: 12 weeks

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

  12. Red Areas

    Time frame: 12 weeks

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

Secondary outcomes

  1. Erythema

    Time frame: 12 weeks

    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.

  2. Burning

    Time frame: 12 weeks

    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.

  3. Peeling

    Time frame: 12 weeks

    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.

  4. Pruritus

    Time frame: 12 weeks

    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.

  5. Dryness

    Time frame: 12 weeks

    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.

  6. Edema

    Time frame: 12 weeks

    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.

  7. Acne

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Makati Medical Center

Other

Collaborators

  • A. Menarini Philippines, Inc.

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 12, 2013
Registry last updated
Sep 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.