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

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.

Study Overview

• Status: Completed
• Conditions: Skin Roughness; Mottling; Blotchiness; Pigmentation; Fine Wrinkles
• Intervention / Treatment: Other: Kinerase

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10500
    • I-Sky Center Chidlom branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Exclusion Criteria:

1. Male and female subjects with suspected porphyria, systemic or cutaneous erythematosus lupus, 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, molluscum contagiosum, 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 in the 2 months preceding the screening visit.
6. Subjects with a history of topical and/or oral isotretinoin use, 6 months prior to the screening visit.
7. Subjects who have been on topical Retin-A or Renova in the 2 months prior to the screening visit.
8. Subjects who have used topical alpha-hydroxy acid skin care products in the month preceding the screening visit.
9. Subjects currently on any anti-aging products and who wish to continue use of their products.
10. Subjects requiring concurrent treatment that would interfere with the study assessments.
11. Pregnant or lactating female subjects.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kinerase	Other: Kinerase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the physician's evaluation and patient's self-evaluation at 12 weeks.	12 weeks
To assess the physician's evaluation and patient's self-evaluation at 4 weeks.	4 weeks
To assess the physician's evaluation and patient's self-evaluation at 8 weeks.	8 weeks

Collaborators and Investigators

• Sponsor: Menarini (Thailand) Limited
• Investigators: Principal Investigator: Rungsima Wanitphakdeedecha, MD, MA, MSc, iSKY Innovative Skin & Laser Surgery Center

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: June 20, 2013
• First Submitted That Met QC Criteria: June 20, 2013
• First Posted (Estimate): June 24, 2013

Study Record Updates

• Last Update Posted (Estimate): June 25, 2013
• Last Update Submitted That Met QC Criteria: June 23, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Growth Substances; Plant Growth Regulators; Kinetin
• Other Study ID Numbers: K.I.S.S