Skin RoughnessPhase 4NCT01885091
Efficacy and Safety Study of Kinerase® for Treatment of Cutaneous Facial Photodamage
A Phase 4 study testing Kinerase in people with Skin Roughness and Mottling, run by Menarini (Thailand) Limited at 1 site in Thailand.
Trial summary
The purpose of the K.I.S.S. study is to evaluate the efficacy of Kinerase® Cream (Kinetin 0.1%) in Thai patients, on the basis of the severity and clinical signs of facial photodamage. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Skin Roughness, Mottling, Blotchiness
- What is being tested?
- Kinerase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2012to Mar 2013
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects older than 35 years of age and less than 65 years of age.
- Subjects with mild, moderate or severe facial photodamage as assessed by a 10-point scale.
- Subjects willing to sign an informed consent and adhere to all protocol requirements.
Who cannot join
- Male and female subjects with suspected porphyria, systemic or cutaneous erythematosus lupus, or any other photosensitizing disorder or drug-induced photosensitization.
- Subjects with chronic or recurring skin disease or disorder.
- Subjects with any active infectious skin disorder (Herpes simplex, molluscum contagiosum, and facial warts).
- Subjects with skin cancer of the facial tissues.
- Subjects who have received any laser/ intense pulsed light (IPL) / chemical peel in the 2 months preceding the screening visit.
- Subjects with a history of topical and/or oral isotretinoin use, 6 months prior to the screening visit.
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- Subjects who have been on topical Retin-A or Renova in the 2 months prior to the screening visit.
- Subjects who have used topical alpha-hydroxy acid skin care products in the month preceding the screening visit.
- Subjects currently on any anti-aging products and who wish to continue use of their products.
- Subjects requiring concurrent treatment that would interfere with the study assessments.
- Pregnant or lactating female subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kinerase® Interactive Skin-care Study: A Multicentre, Phase IV, Single-arm, Open-label Trial to Evaluate the Efficacy and Safety of Kinetin, N6-furfuryladenine, 0.1% for Treatment of Cutaneous Facial Photodamage
The purpose of the K.I.S.S. study is to evaluate the efficacy of Kinerase® Cream (Kinetin 0.1%) in Thai patients, on the basis of the severity and clinical signs of facial photodamage.
- Conditions
- Skin Roughness, Mottling, Blotchiness, Pigmentation, Fine Wrinkles
- Being tested
- Kinerase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KineraseOther
| Study group | Role | What they receive |
|---|---|---|
| Kinerase | Experimental | Not described Receives: Other: Kinerase |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the physician's evaluation and patient's self-evaluation at 12 weeks.
Measured: 12 weeks
To assess the physician's evaluation and patient's self-evaluation at 4 weeks.
Measured: 4 weeks
To assess the physician's evaluation and patient's self-evaluation at 8 weeks.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startDec 2012
- Primary completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin RoughnessStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menarini (Thailand) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rungsima Wanitphakdeedecha, MD, MA, MSc, Principal investigator, iSKY Innovative Skin & Laser Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885091
- Sponsor's protocol ID
- K.I.S.S
- Status last verified
- Jun 2013
- First submitted
- 20 Jun 2013
- Last updated
- 25 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinerase® Interactive Skin-care Study: A Multicentre, Phase IV, Single-arm, Open-label Trial to Evaluate the Efficacy and Safety of Kinetin, N6-furfuryladenine, 0.1% for Treatment of Cutaneous Facial Photodamage
- ClinicalTrials.gov ID
- NCT01885091
- Acronym / sponsor ID
- K.I.S.S
- Conditions
- Skin Roughness, Mottling, Blotchiness, Pigmentation, Fine Wrinkles
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Menarini (Thailand) LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Mar 2013 (actual)
- First posted
- 24 Jun 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 K.I.S.S. study is to evaluate the efficacy of Kinerase® Cream (Kinetin 0.1%) in Thai patients, on the basis of the severity and clinical signs of facial photodamage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kinerase | Experimental | Other: Kinerase |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects older than 35 years of age and less than 65 years of age.
- Subjects with mild, moderate or severe facial photodamage as assessed by a 10-point scale.
- Subjects willing to sign an informed consent and adhere to all protocol requirements.
Key exclusion criteria (11 listed)
- Male and female subjects with suspected porphyria, systemic or cutaneous erythematosus lupus, or any other photosensitizing disorder or drug-induced photosensitization.
- Subjects with chronic or recurring skin disease or disorder.
- Subjects with any active infectious skin disorder (Herpes simplex, molluscum contagiosum, and facial warts).
- Subjects with skin cancer of the facial tissues.
- Subjects who have received any laser/ intense pulsed light (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 |
|---|---|---|
| Kinerase | Other | Kinerase |
Primary outcome
To assess the physician's evaluation and patient's self-evaluation at 12 weeks.
Time frame: 12 weeks
To assess the physician's evaluation and patient's self-evaluation at 4 weeks.
Time frame: 4 weeks
To assess the physician's evaluation and patient's self-evaluation at 8 weeks.
Time frame: 8 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 25 Jun 2013.
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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.
Rungsima Wanitphakdeedecha, MD, MA, MSc principal investigator
iSKY Innovative Skin & Laser Surgery Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Kinerase in people with Skin Roughness and Mottling, run by Menarini (Thailand) Limited at 1 site in Thailand.
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 25 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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?
To assess the physician's evaluation and patient's self-evaluation at 12 weeks. (time frame: 12 weeks). The study lists 3 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 25 Jun 2013.