Efficacy and Safety of Kinetin 0.1% for Treatment of Skin Photoaging

NCT01898182 | Completed Phase 4 DMC

• 1 other identifier: MMCDeptofDerma-Kinerase-2013
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to evaluate the change in the severity and clinical signs of skin photoaging among Filipino patients using Kinerase cream (Kinetin 0.1%). This study will recruit 132 subjects from dermatological clinics in a tertiary hospital in the Philippines for a period of 3 months (12 weeks). Changes in severity will be documented using physician evaluation, self-evaluation, and through VISIA complexion analysis system.

Conditions

Cutaneous Photoaging

Outcome Measures

Primary Outcomes (12)

• Skin Roughness

  Measured using Physician Evaluation and Patient Self-Evaluation of severity of cutaneous photoaging at baseline week, weeks 4, 8, and 12

  12 weeks

• Pigmentation

  Also called Mottling or Blotchiness. This is measured using Physician Evaluation and Patient Self-Evaluation of severity of cutaneous photoaging at baseline week, weeks 4, 8, and 12

  12 weeks

• Fine wrinkles

  Measured using Physician Evaluation and Patient Self-Evaluation of severity of cutaneous photoaging at baseline week, weeks 4, 8, and 12

  12 weeks

• Global Improvement in Cutaneous Photoaging

  Measured using Physician Evaluation and Patient Self-Evaluation of severity of cutaneous photoaging at baseline week, weeks 4, 8, and 12

  12 weeks

• Pores

  Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.

  12 weeks

• Wrinkles

  Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.

  12 weeks

• Texture

  Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.

  12 weeks

• Porphyrins

  Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.

  12 weeks

• Visual Spots

  Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.

  12 weeks

• UV spots

  Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.

  12 weeks

• Brown Spots

  Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.

  12 weeks

• Red Areas

  Measured using VISIA Complexion Analysis System at baseline week, weeks 4 and 8.

  12 weeks

Secondary Outcomes (7)

• Erythema

  12 weeks

• Burning

  12 weeks

• Peeling

  12 weeks

• Pruritus

  12 weeks

• Dryness

  12 weeks

Study Arms (1)

Kinerase

EXPERIMENTAL

Kinetin (N6-furfuryladenine) is an essential bio growth factor that regulates cell growth and is proven to delay and reverse the signs of aging. Kinerase has been found out to significantly improve the appearance of skin texture, mottled hyperpigmentation and fine wrinkles. It does not cause the cutaneous side effects that result from other commonly used anti-aging products. The Kinerase cream contains: Water, glyceryl stearate, propylene glycol, butylenes glycol, glycerin, cetyl alcohol, stearic acid, isopropyl palmitate, squalene, stearyl alcohol, glycene soja sterols, dimethicone, laureth-23, aloe barbadensis leaf juice, phenoxyethanol, carbomer, ethylhexyglycerin, sodium hydroxide, soluble collagen, kinetin, panthenol, tocopherol, citric acid, sodium citrate, hydrolysed elastin.

Other: Kinetin, N6-furfuryladenine, 0.1%

Interventions

Kinetin, N6-furfuryladenine, 0.1% OTHER

Also known as: Kinerase cream

Kinerase

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Filipino and Asian female subjects from private clinics of a tertiary hospital in the Philippines older than 35 years of age and less than 65 years of age.
• Subjects with mild to moderate cutaneous photoaging as assessed by the investigator's assessment 6-point scale.
• Subjects willing to sign an informed consent and adhere to all protocol requirements.

You may not qualify if:

• Suspected porphyria, systemic or cutaneous lupus erythematosus, or any other photosensitizing disorder or drug-induced photosensitization
• Chronic or recurring skin disease or disorder
• Any active infectious skin disorder (Herpes simplex, molluscum contagiosum, and facial warts)
• Skin cancer of the facial tissues
• Any laser/IPL/ chemical peel in the 2 months preceding the screening visit
• History of Isotretinoin use, 6 months prior to the screening disease
• Topical tretinoin or adapalene in the 2 months prior to the screening visit
• Used topical alpha-hydroxy acid skincare products in the month preceding the screening visit
• On any anti-aging products and who wish to continue use of their products
• Requiring concurrent treatment that would interfere with the study assessments
• Pregnant or lactating females

Sponsors & Collaborators

• Makati Medical Center: lead
• A. Menarini Philippines, Inc.: collaborator

Study Sites (2)

Makati Medical Center

Makati City, National Capital Region, 1229, Philippines

Location

Makati Medical Center Department of Dermatology

Makati City, NCR, 1229, Philippines

Location

MeSH Terms

Interventions

Kinetin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ma. Purita P. Lao, MD, FPDS

  Makati Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 12, 2013
• Study Start: November 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 15, 2014

Record last verified: 2014-09

Locations

PH (2)