| CTRI Number |
CTRI/2019/09/021246 [Registered on: 16/09/2019] Trial Registered Prospectively |
| Last Modified On: |
13/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Dermatological] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
In this study the effectiveness and safety of Olepent as an anti ageing cream will be evaluated in comparison to an inert cream in healthy female volunteers. |
|
Scientific Title of Study
|
A randomized, double-blind, placebo controlled, monocentric study to evaluate the Anti Ageing efficacy and safety of Olepent® cream in Healthy female subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CPL/82/OPT_AGNG/I/JUL/19V1.028-AUG-19 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukesh Ramnane |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Private Limited |
| Address |
Dermatology Department
327/15,1st Main Road, Cambridge Layout, Ulsoor, Bangalore.
Bangalore
KARNATAKA
560008
India |
| Phone |
09844020353 |
| Fax |
|
| Email |
mukesh.ramnane@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpesh Shah |
| Designation |
Senior Vice President |
| Affiliation |
ClinWorld Private Limited |
| Address |
19/1 & 19/2,I Main,II Phase, Peenya Industrial Area, Bangalore.
Bangalore
KARNATAKA
560058
India |
| Phone |
08028397973 |
| Fax |
|
| Email |
kalpesh@clinworld.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpesh Shah |
| Designation |
Senior Vice President |
| Affiliation |
ClinWorld Private Limited |
| Address |
19/1 & 19/2,I Main,II Phase, Peenya Industrial Area, Bangalore.
Bangalore
KARNATAKA
560058
India |
| Phone |
08028397973 |
| Fax |
|
| Email |
kalpesh@clinworld.org |
|
|
Source of Monetary or Material Support
|
| Sami Labs Limited
19/1 & 19/2,I Main,II Phase, Peenya Industrial Area,Bangalore.560058. |
|
|
Primary Sponsor
|
| Name |
Sami Labs Limited |
| Address |
19/1 & 19/2,I Main,II Phase, Peenya Industrial Area,Bangalore,Karnataka. 560058. |
| Type of Sponsor |
Other [Manufactures and markets phytonutrients, standardized herbal extracts and nutritional supplements. ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mukesh Ramnane |
MS Clinical Research Private Limited |
Dermatology Department
327/15,1st Main Road, Cambridge Layout,Ulsoor,Bangalore,Karnataka.560008.
Bangalore
KARNATAKA |
09844020353
mukesh.ramnane@mscr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLINICOM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adult female volunteers with Fitzpatrick skin types III to V. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Olepent® cream |
1 FTU application twice a day (morning and night)on full face up to eight weeks. |
| Comparator Agent |
Placebo |
1 FTU application twice a day (morning and night)on full face up to eight weeks. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1 Female adult subjects in general good health as determined from a recent medical history general physical examination, dermatological assessment.
2 Subjects in the age group of 35-50 years (both ages inclusive).
3 Subject with Fitzpatrick skin types III to V.
4 Subjects having visible fine lines and wrinkles in periorbital area (Crows feet under eye) and forehead
5 Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.
6 Subject who agrees not to use any other product/treatment/home remedy except the provided dove soap bar on their face during the study period other than the test product.
7 Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period.
8 Subjects who agree not to expose to excessive sun light. (Sun exposure not more than half an hour daily and during that time use of umbrella to cover face).
9 Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow up.
10 Subjects willing to abide by and comply with the study protocol. |
|
| ExclusionCriteria |
| Details |
1 Subject with any other signs of significant local irritation or skin disease.
2 Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data.
3 Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year.
4 Subjects who do not agree to remove all jewellery on/around face (e.g. necklace,earrings,if possible nose ring),during VISIA imaging.
5 Subjects having hairstyle which covers almost the entire forehead.
6 Subjects undergoing any treatment of any skin condition on their face/forearm.
7 Subjects not willing to discontinue other topical facial products.
8 Subject allergic or sensitive to bar cleansing products, cosmetics, creams/lotions, artificial jewellery or anything else.
9 Pregnant women (as confirmed by UPT) and lactating women.
10 Subjects on any medical treatment either systemic/topical in the past 1 month or currently taking medication including food supplements.
11 Subjects with skin allergy history or atopic dermatitis or psoriasis
12 Subjects who have participated in any other clinical trial in the last 3 months.
13 Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study
14 Subjects that was treated with botox/filler /biostimulatory molecules injection. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 Mean reduction in facial fine line, wrinkles and elasticity as assessed by Antera & Dermatological visual assessment |
1 Mean reduction in facial fine line, wrinkles and elasticity as assessed by Antera & Dermatological visual assessment (Screening, Baseline, Day 28 and Day 56) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Mean reduction in facial fine line; wrinkles and elasticity - VISIA CR; Cutometer
2 Mean change in skin quality as assessed by Skin texture, firmness & elasticity scale (In use scales); validated Crows feet grading scale & by Self assessment.
3 Mean increase in skin hydration - Corneometer.
4 Evaluation of safety through monitoring skin tolerance & AE. |
1 Mean reduction in facial fine line;wrinkles and elasticity - VISIA CR,Cutometer (Screening, Baseline,Day28 & Day56)
2 Mean change in skin quality as assessed by Skin texture, firmness & elasticity scale (In use scales); validated Crows feet grading scale & by Self-assessment (Screening, Baseline,Day28 & Day56).
3 Mean increase in skin hydration - Corneometer (Screening, Baseline,Day28 & Day56).
4 Evaluation of safety through monitoring skin tolerance & AE (Baseline, Day28 & Day56). |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/09/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this trial the efficacy and
safety of Olepent® will be evaluated in healthy female volunteers
aged 35 to 50 years (both inclusive) with Fitzpatrick skin types III to V.
Approximately 56 subjects will be enrolled, 24 subjects in each cohort are
expected to complete the study. The study duration will be eight weeks for
each subject. The primary endpoints for the study will be mean reduction in
facial fine lines, wrinkles and elasticity as assessed by Antera &
Dermatological visual assessment. The secondary endpoints will be mean
reduction in facial fine lines, wrinkles and elasticity as assessed by VISIA CR
and Cutometer, mean change in skin quality as assessed by Skin texture,
firmness & elasticity scale (In use scales), validated Crows feet grading
scale and by self-assessment, mean increase in skin hydration as assessed by
Corneometer and evaluation of safety through monitoring skin tolerance and
occurrence of adverse events. |