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

NCT01885091 | Completed Phase 4

• 1 other identifier: K.I.S.S
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Roughness; Mottling; Blotchiness; Pigmentation; Fine Wrinkles

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Kinerase

EXPERIMENTAL

Other: Kinerase

Interventions

Kinerase OTHER

Kinerase

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menarini (Thailand) Limited: lead

Study Sites (1)

I-Sky Center Chidlom branch

Bangkok, Bangkok, 10500, Thailand

Location

MeSH Terms

Interventions

Kinetin

Intervention Hierarchy (Ancestors)

Cytokinins; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Rungsima Wanitphakdeedecha, MD, MA, MSc

  iSKY Innovative Skin & Laser Surgery Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: June 24, 2013
• Study Start: December 1, 2012
• Primary Completion: March 1, 2013
• Last Updated: June 25, 2013

Record last verified: 2013-06

Locations

TH (1)