Cutaneous PhotoagingPhase 4NCT01898182
Efficacy and Safety of Kinetin 0.1% for Treatment of Skin Photoaging
A Phase 4 study testing Kinetin, N6-furfuryladenine, 0.1% in people with Cutaneous Photoaging, run by Makati Medical Center at 2 sites in Philippines.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Photoaging
- What is being tested?
- Kinetin, N6-furfuryladenine, 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesPhilippines
- Study dates
- Nov 2013to Sep 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Philippines2 sites
Makati Medical Center
Makati City, National Capital Region, 1229
Makati Medical Center Department of Dermatology
Makati City, NCR, 1229
About this study
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
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.
Read the 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.
- Conditions
- Cutaneous Photoaging
- Being tested
- Kinetin, N6-furfuryladenine, 0.1%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinetin, N6-furfuryladenine, 0.1%Other
Also called Kinerase cream
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Kinetin, N6-furfuryladenine, 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Roughness
Measured using Physician Evaluation and Patient Self-Evaluation of severity of cutaneous photoaging at baseline week, weeks 4, 8, and 12
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks
Pores
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
Measured: 12 weeks
Wrinkles
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
Measured: 12 weeks
Texture
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
Measured: 12 weeks
Porphyrins
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
Measured: 12 weeks
Visual Spots
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
Measured: 12 weeks
UV spots
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
Measured: 12 weeks
Brown Spots
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
Measured: 12 weeks
Red Areas
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
Measured: 12 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous PhotoagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makati Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- A. Menarini Philippines, Inc.
- Responsible party
- Principal investigator, Ma. Purita Paz-Lao, MD, FPDS, Makati Medical Center
- Investigators
- Ma. Purita P. Lao, MD, FPDS, Principal investigator, Makati Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898182
- Sponsor's protocol ID
- MMCDeptofDerma-Kinerase-2013
- Status last verified
- Sep 2014
- First submitted
- 3 Jul 2013
- Last updated
- 15 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01898182
- Acronym / sponsor ID
- MMCDeptofDerma-Kinerase-2013
- Conditions
- Cutaneous Photoaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Makati Medical CenterUniversity, hospital or other
- Collaborators
- A. Menarini Philippines, Inc.
- Study start
- Nov 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kinerase | Experimental | Other: Kinetin, N6-furfuryladenine, 0.1%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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinetin, N6-furfuryladenine, 0.1%Also: Kinerase cream | Other | Kinerase |
Primary outcome
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
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
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
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
Pores
Time frame: 12 weeks
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
Wrinkles
Time frame: 12 weeks
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
Texture
Time frame: 12 weeks
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
Porphyrins
Time frame: 12 weeks
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
Visual Spots
Time frame: 12 weeks
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
UV spots
Time frame: 12 weeks
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
Brown Spots
Time frame: 12 weeks
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
Red Areas
Time frame: 12 weeks
Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.
7 secondary outcomes
Erythema
Time frame: 12 weeks
Burning
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
Related trials for Cutaneous Photoaging
Active, not recruiting
Investigating Age Dependence of Fibroblast and Extracellular Matrix Responses to Cross-linked Hyaluronic Acid Filler in Human Skin
Photoaging
Not yet recruiting
Clinical Trial to Assess the Efficacy and Safety of a Cosmetic Product in Individuals Showing Signs of Cutaneous Aging.
Skin, Skin Ageing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ma. Purita P. Lao, MD, FPDS principal investigator
Makati Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Kinetin, N6-furfuryladenine, 0.1% in people with Cutaneous Photoaging, run by Makati Medical Center at 2 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Roughness (time frame: 12 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2014.