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

Last updated: June 23, 2013
Sponsor: Menarini (Thailand) Limited
Overall Status: Completed

Phase

4

Condition

Skin Aging

Treatment

N/A

Clinical Study ID

NCT01885091
K.I.S.S
  • Ages 35-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male and female subjects older than 35 years of age and less than 65 years of age.

  2. Subjects with mild, moderate or severe facial photodamage as assessed by a 10-pointscale.

  3. Subjects willing to sign an informed consent and adhere to all protocol requirements.

Exclusion

Exclusion Criteria:

  1. Male and female subjects with suspected porphyria, systemic or cutaneous erythematosuslupus, or any other photosensitizing disorder or drug-induced photosensitization.

  2. Subjects with chronic or recurring skin disease or disorder.

  3. Subjects with any active infectious skin disorder (Herpes simplex, molluscumcontagiosum, and facial warts).

  4. Subjects with skin cancer of the facial tissues.

  5. Subjects who have received any laser/ intense pulsed light (IPL) / chemical peel inthe 2 months preceding the screening visit.

  6. Subjects with a history of topical and/or oral isotretinoin use, 6 months prior to thescreening visit.

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

  8. Subjects who have used topical alpha-hydroxy acid skin care products in the monthpreceding the screening visit.

  9. Subjects currently on any anti-aging products and who wish to continue use of theirproducts.

  10. Subjects requiring concurrent treatment that would interfere with the studyassessments.

  11. Pregnant or lactating female subjects.

Study Design

Total Participants: 100
Study Start date:
December 01, 2012
Estimated Completion Date:

Connect with a study center

  • I-Sky Center Chidlom branch

    Bangkok, 10500
    Thailand

    Site Not Available

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