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OpenTrials
Completed

NCT Number: NCT01885091

Efficacy and Safety Study of Kinerase® 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.

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Key information

Conditions

Skin Roughness Blotchiness Fine Wrinkles Mottling Pigmentation

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

I-Sky Center Chidlom branch

Bangkok, 10500, Thailand

Who can participate

Healthy volunteers accepted: No

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

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.
  • 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.

Treatment and study plan

Kinerase

Other

Primary outcomes

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

    Time frame: 12 weeks

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

    Time frame: 4 weeks

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

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Menarini (Thailand) Limited

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
First posted
Jun 24, 2013
Registry last updated
Jun 25, 2013

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.

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