CompletedPhase 4

Efficacy and Safety Study of Kinerase® for Treatment of Cutaneous Facial Photodamage

Thailand100 participantsStarted 2012-12

Plain-language 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.

Who can participate

Age range

35 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.
. Subjects who have been on topical Retin-A or Renova in the 2 months prior to the screening visit.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess the physician's evaluation and patient's self-evaluation at 12 weeks.

Timeframe: 12 weeks

To assess the physician's evaluation and patient's self-evaluation at 4 weeks.

Timeframe: 4 weeks

To assess the physician's evaluation and patient's self-evaluation at 8 weeks.

Timeframe: 8 weeks

Trial details

NCT IDNCT01885091

SponsorMenarini (Thailand) Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-03

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