| CTRI Number |
CTRI/2023/09/057260 [Registered on: 06/09/2023] Trial Registered Prospectively |
| Last Modified On: |
01/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Topical treatment] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the reduction of dark spots on the face |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Lightinderm device augmented spot corrector serum use in reducing the hyperpigmented spots in healthy female subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/LDSR/2023-01 Version 1.0 dated 31 July 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
Second floor, Evaluation room no. 1, 327/15, 1st Main Road,
Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
Second floor, Evaluation room no. 1, 327/15, 1st Main Road,
Cambridge layout, Ulsoor
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
Second floor, Evaluation room no. 1, 327/15, 1st Main Road,
Cambridge layout, Ulsoor
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
08040917253 |
| Email |
mukta.sachdev@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Lightinderm
Hôpital Cochin, Paris Biotech Santé - 27 rue du Faubourg Saint Jacques - 75014 Paris (France) |
|
|
Primary Sponsor
|
| Name |
Lightinderm |
| Address |
Hôpital Cochin, Paris Biotech Santé - 27 rue du Faubourg Saint Jacques - 75014 Paris (France) |
| Type of Sponsor |
Other [Cosmetic industry] |
|
|
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 Mukta Sachdev |
MS Clinical Research Pvt. Ltd |
Second floor, Evaluation room no. 1, 327/15, 1st Main Road,
Cambridge layout, Ulsoor
Bangalore
KARNATAKA |
08041125934
08040917253
mukta.sachdev@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy female participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Spot corrector serum applied with Ligthinderm device |
Treatment will be done once per day in the evening for 3 minutes on clean and dry skin with the device + serum (programme SPOT CORRECTOR). |
|
|
Inclusion Criteria
|
| Age From |
18.00 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 18-50 years (both ages inclusive).
3. Subjects with various skin types, including normal, dry, oily, and combination, while excluding those with sensitive skin.
4. Subjects with skin phototype III to VI
5. Subjects presenting with uneven skin tone and hyperpigmented spots on the face with a subset of 10 subjects with melasma
6. Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face as determined by the dermatologist.
7. Subject who agrees not to use any other product/treatment/home remedy/ except the provided product on their face during the study period other than the test and additional products of the study.
8. Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period.
9. 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).
10. Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
11. 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 CR imaging.
5. Subjects having hair style which covers almost the entire forehead
6. Subjects undergoing any treatment of any skin condition on their face
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. Subjects who are pregnant and lactating
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 of atopic dermatitis or psoriasis
12. Subjects who have participated in any other clinical trial in the last 3 months.
13. Subjects who have undergone treatment with Botox/filler /bio stimulatory molecules injection in the past six months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate & compare the efficacy of the Lightinderm device augmented spot corrector serum in providing a reduction in the visibility of spots (intensity) & hyperpigmentation while enhancing the skin luminosity and improving skin tone evenness as per dermatological assessments and non-invasive instruments (Spectrophotometer, VISIA CR, Antera) in 8 weeks when compared to the baseline. |
T0, Week 1, Week 4, Week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate improvement in skin clarity, skin texture (exploratory)
2. To evaluate efficacy, safety & skin tolerance of test products in a long-term use for 8 weeks by dermatological evaluation and subjective feedback |
T0, Week 1, Week 4, Week 8 |
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
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 2 |
|
Date of First Enrollment (India)
|
13/09/2023 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Healthy female subjects who meet the inclusion and
exclusion criteria will be enrolled upon obtaining informed consent, with an
initial screening of 43 subjects aiming for 35 to complete the study. Following
enrollment, subjects will cleanse their faces and acclimatize before undergoing
baseline dermatological and non-invasive assessments, including instrumental and dermatological evaluations.
Subsequently, subjects will receive training in using the test device, with the
first application supervised by designated personnel. Throughout the study,
subjects will utilize the test device with spot corrector serum cartridges
provided, attending compliance checks and follow-up visits, where used
cartridges will be replaced, and additional serum dispensed. The study will
conclude at week 8, at which point the device, both used and unused cartridges,
will be returned, and subjects will be given day cream and sunscreen. Subjects
must adhere to provided skincare products exclusively and attend week 1, week 4 and
week 8 assessments as instructed. |