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

Menarini

Status and phase

Completed

Phase 4

Conditions

Skin Roughness

Blotchiness

Mottling

Pigmentation

Fine Wrinkles

Treatments

Other: Kinerase

Study type

Interventional

Funder types

Industry

Identifiers

NCT01885091

K.I.S.S

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

35 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.