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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01486303
Other study ID # KHNMC-OH-IRB2011-007
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 14, 2011
Last updated December 5, 2011
Start date August 2011

Study information

Verified date December 2011
Source Kyunghee University
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry for Health and Welfare
Study type Interventional

Clinical Trial Summary

Facial Cosmetic Acupuncture technique includes wrinkles, acupoints and muscle points on the face, head and neck. This study is designed to determine the efficacy and safety of Facial Cosmetic Acupuncture on skin rejuvenation.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 28
Est. completion date
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 59 Years
Eligibility Inclusion Criteria:

- Patient age of 40 to 59 years

- Glogau photoaging scale III-IV

Exclusion Criteria:

- Who had undergone any dermabrasion, deep skin peels, laser resurfacing (ablative or non-ablative), botulinum toxin or filler injection, topical steroid within 6 months prior to study entry

- Patient with obvious skin disease

- Patient with a history of chronic skin disease

- Keloidal or hypertrophic scar tendency

- Pregnant or lactating patients

Study Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
Facial Cosmetic Acupuncture
Patients received five treatment sessions during 3 weeks. Facial cosmetic acupuncture was applied at muscles and acupoints on the face, head and neck

Locations

Country Name City State
Korea, Republic of Kyung Hee University Hospital at Gangdong Seoul

Sponsors (1)

Lead Sponsor Collaborator
Kyunghee University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Criteria for evaluating Moire's topography The investigators generated a contour line on the face using Moire's system, and then took a picture with a digital camera Ixus750 (Canon, Tokyo, Japan). Three independent evaluators will read the contour lines near the cheek and the perioral region in the printed digital image and grade images base on the Criteria for evaluating Moire's topography (Skin Research and Technology 2007;13:280-284). The average values from three evaluators will be used in subsequent calculations. At 3 weeks (post treatment) No
Secondary Glogau classification system At 3 weeks (post treatment) No
Secondary One-click Automatic Full face Analysis system Improvement of Pore, Sebum, wrinkle, pigment, moisture, elasticity, skin temperature based on automatic analysis by Scanner and Multi-Sensor of One-click Automatic Full face Analysis system. Outcomes will be graded from 0 to 4. At 3 weeks (post treatment) No
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