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

Pigmentation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885091
• Other study ID #: K.I.S.S
• Status: Completed
• Phase: Phase 4
• First received: June 20, 2013
• Last updated: June 23, 2013
• Start date: December 2012

Study information

• Verified date: June 2013
• Source: Menarini (Thailand) Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blotchiness
• Fine Wrinkles
• Mottling
• Pigmentation
• Skin Roughness

Intervention

Other:
• Kinerase

Locations

Country	Name	City	State
Thailand	I-Sky Center Chidlom branch	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Menarini (Thailand) Limited

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the physician's evaluation and patient's self-evaluation at 12 weeks.		12 weeks	No
Primary	To assess the physician's evaluation and patient's self-evaluation at 4 weeks.		4 weeks	No
Primary	To assess the physician's evaluation and patient's self-evaluation at 8 weeks.		8 weeks	No