Skin AgingNCT01486303
Facial Cosmetic Acupuncture on Skin Rejuvenation
A study testing Facial Cosmetic Acupuncture in people with Skin Aging and Skin Wrinklings, run by Kyunghee University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 40 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging, Skin Wrinklings
- What is being tested?
- Facial Cosmetic Acupuncture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient age of 40 to 59 years
- Glogau photoaging scale III-IV
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kyung Hee University Hospital at Gangdong
Seoul, 134-727
About this study
Official title: Efficacy and Safety of Facial Cosmetic Acupuncture on Skin Rejuvenation
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.
- Conditions
- Skin Aging, Skin Wrinklings
- Being tested
- Facial Cosmetic Acupuncture
- Keywords
- Facial Cosmetic acupuncture, Skin Rejuvenation, Skin Aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial Cosmetic AcupunctureProcedure or surgery
Patients received five treatment sessions during 3 weeks. Facial cosmetic acupuncture was applied at muscles and acupoints on the face, head and neck
| Study group | Role | What they receive |
|---|---|---|
| Facial Cosmetic Acupuncture | Experimental | 28 Patients with grade III to IV wrinkling on the face, according to the Glogau classification system, were treated with Facial Cosmetic Acupuncture. Receives: Procedure: Facial Cosmetic Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 3 weeks (post treatment)
Secondary outcomes (2)
Glogau classification system
Measured: At 3 weeks (post treatment)
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.
Measured: At 3 weeks (post treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inhwa Choi, Kyunghee University
- Investigators
- In-Hwa Choi, KMD,PhD, Study chair, Department of Oriental Dermatology, College of Oriental Medicine, Kyung Hee UniversityYounghee Yun, KMD,Master, Principal investigator, Department of Oriental Dermatology, College of Oriental Medicine, Kyung Hee University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486303
- Sponsor's protocol ID
- KHNMC-OH-IRB2011-007
- Status last verified
- Dec 2011
- First submitted
- 14 Nov 2011
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Facial Cosmetic Acupuncture on Skin Rejuvenation
- ClinicalTrials.gov ID
- NCT01486303
- Acronym / sponsor ID
- KHNMC-OH-IRB2011-007
- Conditions
- Skin Aging, Skin Wrinklings
- Keywords
- Facial Cosmetic acupuncture, Skin Rejuvenation, Skin Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Kyunghee UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (estimated)
- First posted
- 6 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Facial Cosmetic Acupuncture | Experimental | Procedure: Facial Cosmetic Acupuncture28 Patients with grade III to IV wrinkling on the face, according to the Glogau classification system, were treated with Facial Cosmetic Acupuncture. |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patient age of 40 to 59 years
- Glogau photoaging scale III-IV
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facial Cosmetic AcupuncturePatients received five treatment sessions during 3 weeks. Facial cosmetic acupuncture was applied at muscles and acupoints on the face, head and neck | Procedure or surgery | Facial Cosmetic Acupuncture |
Primary outcome
Criteria for evaluating Moire's topography
Time frame: At 3 weeks (post treatment)
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.
2 secondary outcomes
Glogau classification system
Time frame: At 3 weeks (post treatment)
One-click Automatic Full face Analysis system
Time frame: At 3 weeks (post treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2011.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Hwa Choi, KMD,PhD study chair
Department of Oriental Dermatology, College of Oriental Medicine, Kyung Hee University
Younghee Yun, KMD,Master principal investigator
Department of Oriental Dermatology, College of Oriental Medicine, Kyung Hee University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial Cosmetic Acupuncture in people with Skin Aging and Skin Wrinklings, run by Kyunghee University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Criteria for evaluating Moire's topography (time frame: At 3 weeks (post treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2011.