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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01885091
Other study ID # K.I.S.S
Secondary ID
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. completion date
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


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
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