| CTRI Number |
CTRI/2012/01/002325 [Registered on: 09/01/2012] Trial Registered Retrospectively |
| Last Modified On: |
26/07/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to evaluate the safety and effectiveness of the electro muscular stimulation device to improve skin elasticity, firmness and to reduce the signs of facial aging in healthy adults |
|
Scientific Title of Study
|
A single-center, randomized, controlled study to evaluate the safety and effectiveness of the electro muscular stimulation device to improve skin elasticity, firmness and to reduce the signs of facial aging in healthy adults after 10 weeks of product use |
| Trial Acronym |
EMS Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SCR/EMS 2/2011 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Viral Shah |
| Designation |
Medical Director |
| Affiliation |
Spectrum Healthcare |
| Address |
81 - 84 Lady Ratan Tata Medical & Research Centre, M. Karve Road, Cooperage, Mumbai
Mumbai
MAHARASHTRA
400021
India |
| Phone |
02222846357 |
| Fax |
02222846804 |
| Email |
vshah@spectrumcr.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Bharani Bhaskar |
| Designation |
Project Manager |
| Affiliation |
Spectrum Clinical Research Pvt. Ltd. |
| Address |
401, Kshamalaya Building,
37, New Marine Lines, Mumbai
Mumbai
MAHARASHTRA
400020
India |
| Phone |
02240645100 |
| Fax |
02266155567 |
| Email |
bbhaskar@spectrumcr.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Bharani Bhaskar |
| Designation |
Project Manager |
| Affiliation |
Spectrum Clinical Research Pvt. Ltd. |
| Address |
401, Kshamalaya Building,
37, New Marine Lines, Mumbai
Mumbai
MAHARASHTRA
400020
India |
| Phone |
02240645100 |
| Fax |
02266155567 |
| Email |
bbhaskar@spectrumcr.com |
|
|
Source of Monetary or Material Support
|
| Vercel Inc.,Room 1302, 13/F CRF Building,303 Henessy Road,
Wan Chai,Hong Kong |
|
|
Primary Sponsor
|
| Name |
Vercel Inc |
| Address |
Room 1302, 13/F CRF Building,303 Henessy Road, Wan Chai,Hong Kong |
| Type of Sponsor |
Other [Technology] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Spectrum Clinical Research Pvt Ltd |
401, Kshamalaya Building,
37, New Marine Lines, Mumbai - 400 020 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sonali Malvankar |
Spectrum Healthcare |
81 - 84, Lady Ratan Tata Medical & Research Centre, M. Karve Road, Cooperage, Mumbai - 400 021
Maharashtra,
INDIA
Mumbai
MAHARASHTRA |
09819487947
02222846804
smalvankar@spectrumhealthcare.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinical Ethics Forum |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
skin elasticity, firmness and to reduce the signs of facial aging |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ageless WonderTM Facial Muscle Stimulation |
Subjects who will receive Device will use 45 minutes per day, for 10 weeks. |
| Comparator Agent |
Ponds cream (sun protection cream) |
Apply on face in accordance with the instructions given by study doctor for 10 weeks |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Month(s) |
| Gender |
Both |
| Details |
1.35 - 50 years of age.( 40% male and 60% female )
2.Visual signs of aging on the face with mild/moderate to severe wrinkles.
3.In general good health,
•Free of dermatological conditions such as eczema, seborrheic dermatitis and psoriasis.
4.Signing of an Informed Consent Contract in conformance with CFR Part 50: "Protection of Human Subjects".
5.Dependability and intelligence in following directions.
6.Completion of a Panelist Profile/Medical History.
7.Subjects must be willing to maintain their normal diet throughout the duration of the study.
8.Using acceptable methods of birth control. |
|
| ExclusionCriteria |
| Details |
1.Pregnant women (or pregnancy within last 3 months).
2.Inadequate precaution or procedure to prevent pregnancy (women of child- bearing potential only).
3.Treatment for any type of cancer within the last six months.
4.Use of any prescribed anti-inflammatory drug, immunosuppressive drugs or antihistamine medication (steroid nose drops and/or eye drops are permitted). Any over-the-counter pain medication that is ingested in quantities exceeding label instructions.
5.Damaged skin in or around test sites which include sunburn, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles or other disfiguration of the test site.
6.Individuals who have any implanted medical devices (pacemaker, pump, catheter, etc.).
7.Current or history of a medical condition that would contraindicate treatment with the product, such as epilepsy, hernia, abdominal ulcer, diabetes, or other conditions which, in the opinion of the Investigator, would place the participant at risk.
8.A current skin disease of any type at the test site (e.g. acne, eczema, psoriasis, burns, abrasions, etc.)
9.Heavy alcohol consumption in the opinion of the investigator.
10.A fever in the last 12 hours prior to the first application of the test device.
11.History of heart disease.
12.History of stroke.
13.History of malignant disease.
14.Insulin dependent diabetes.
15.Concurrent medication likely to affect the response to the test article or confuse the results of the study (e.g. routine high dose use of any drugs that may artificially affect skin tone).
16.Individuals who are currently participating in any other clinical. Investigation, or who have participated in a study with the same indication within 1 year.
17.Principal investigator for this study, or member of study staff.
18.Participants with skin conditions such as obvious sun damage, increased pigmentation and / or telangectasia.
19.Any dental inflammation or other acute dental condition.
20.Individuals who have had facial surgery.
21.Patients with facial muscle fever. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To improve muscle toning, skin elasticity, firmness, fine line & wrinkle reduction and to reduce the signs of facial aging in healthy adults |
10 weeks after product use |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/01/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of this study is to evaluate the safety and effectiveness of the electro muscular stimulation device to improve muscle toning, skin elasticity, firmness, fine line & wrinkle reduction and to reduce the signs of facial aging in healthy adults after 10 weeks of product use.
This will be a single-center study, randomized, controlled study consisting of 30 healthy adults in test group and 30 healthy subjects in control group between 35 to 50 years of age, meeting the eligibility criteria. Subjects will be allocated in two groups Group - A & Group - B.
Subjects in Group - A will receive study product (Electronic Muscle Stimulator) and basic cream(Pond’s cream)
Subjects in Group - B will receive only basic cream (Pond’s cream)
|