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

Phase 4

Completed

• Conditions: Skin Roughness; Mottling; Blotchiness; Pigmentation; Fine Wrinkles

• Registration Number: NCT01885091
• Lead Sponsor: Menarini (Thailand) Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2013-03
• Status Verified: 2013-06
• Study First Submitted: 2013-06-20
• Study First Submitted QC: 2013-06-20
• Last Update Submitted: 2013-06-23
• Study First Posted: 2013-06-24
• Last Update Posted: 2013-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess the physician's evaluation and patient's self-evaluation at 8 weeks.	8 weeks
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

Trial Locations

Locations (1)

I-Sky Center Chidlom branch; 🇹🇭 Bangkok, Thailand