| CTRI Number |
CTRI/2026/01/101667 [Registered on: 20/01/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of 2 test products on face in males for a time period of 8 weeks. |
|
Scientific Title of Study
|
A clinical study to evaluate efficacy of the two study products for improvement in skin appearance in an 8-week full-face application design with
male participants. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/160/1225/STU Version: 01, 19 Dec 2025 |
Protocol Number |
| SKN-SKA-4487 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajeshree Mayekar |
| Designation |
Principal Investigator - Consultant Dermatologist |
| Affiliation |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD. |
| Address |
5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
9969086194 |
| Fax |
|
| Email |
rajeshreeamc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Preetha Paul |
| Designation |
Senior Manager - TQM |
| Affiliation |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD. |
| Address |
5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
preetha@claimsclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Preetha Paul |
| Designation |
Senior Manager - TQM |
| Affiliation |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD. |
| Address |
5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
preetha@claimsclinical.com |
|
|
Source of Monetary or Material Support
|
| Hindustan Unilever Limited
B.D Sawant Marg, Chakala, Andheri East
Mumbai, Maharashtra - 400099 |
|
|
Primary Sponsor
|
| Name |
Hindustan Unilever Limited |
| Address |
B.D Sawant Marg, Chakala, Andheri East
Mumbai, Maharashtra - 400099 |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Rajeshree Mayekar |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.) |
5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA |
66758851
rajeshreeamc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Claims Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy male volunteers with healthy skin will be included in the study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
D70 |
0.6 gm of the test product will be applied by the participants themselves at their homes, with a minimum of at least 5 hours interval, but not exceeding
12 hours, by the participants themselves at home, for a period of 8 weeks.
|
| Comparator Agent |
NIL |
NIL |
| Intervention |
U55 |
0.6 gm of the test product will be applied by the participants themselves at their homes, with a minimum of at least 5 hours interval, but not exceeding 12 hours, by the participants themselves at home, for a period of 8 weeks. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Male |
| Details |
1. Male participants between 18 to 55 years (both inclusive) of age.
2. Participants are in good health condition as per the health history questionnaire with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data.
3. Participant able to read, understand and sign an appropriate informed consent form indicating
her willingness to participate.
4. Participants having skin forehead color in the range of 4 to 7.25 (as per Unilever India Clinical
Skin Colour Shade Card). 2 to 3 participants will be selected having forehead skin color of 4 as
well as 7.25. The participants to be enrolled across the entire colour range (i.e. not skewed
towards a few shades)
5. Having 3 spots of 3 mm diameter. Spot Type, Size, No. of spots- Participant having about 3 spots (freckles or solar Lentigines or senile lentigines or PIH post acne) on full face, with at least one spot of 3 mm and the other two spots of greater than or equal to 2 mm. A minimum of 30 spots needed for each spot type out of
150 spots per cell, i.e.,
• 30 spots of Freckles to complete
• 30 spots of Solar lentigines or sunspots to complete
• 30 spots of PIH
• Remaining spots can be of any of the spot type
6. Note: Recruitment to be done basis existing CRO database or as during screening with
documented evidence of 3 years of sunspots history for the same spot selected in this study (type
of evidence used needs to be documented in EDC against each sunspot). Declaration from
dermat to also be provided along with study completion report.
7. Participants will be selected to have a range of forehead skin brightness (L) as follows:
• 50–55 = 50 percent of participants
• 46–49 = 25 percent of participants
• 40–45 and 56–60 or 65 = remaining 25 percent
8. Participants having uneven pigmentation (mild to moderate) on face e.g., pigmentary uneven
skin tone patches, spots/hyperpigmentation. Very large patches on face to be avoided.
9. Having moderate facial skin dryness (Score 2.0 on UL dryness scale: Generalized slight powderiness. Early cracking or occasional small lifting scales may be present). Note: Based on the weather conditions at the time of screening, in case of difficulty in perceiving facial visual dryness, skin hydration readings as measured by Corneometer to be less than or equal to 30 units may be considered Not having outdoor job that requires lots of sun exposure. Note- Self perceived skin type will be
recorded at the time of recruitment.
10.Not having outdoor job that requires lots of sun exposure. Note: Self perceived skin type will be recorded at the time of recruitment.
11. Participants are free of persistent acne, cuts, abrasions, fissures, wounds, and lacerations on face.
12. Participants are willing to participate in the study (Time of their stay at clinical site (9 to 10 hrs.)
on the study visit days including screening visit). |
|
| ExclusionCriteria |
| Details |
1. Participants who are employees of Unilever or CRO.
2. Participants who participated in a study involving the treatment site within 2 months of
the start of this study or is currently participating in such a study.
3. Participants with dry or scaly facial skin.
4. Participants with any other signs of significant local irritation, erythema, or skin disease on the face and as well as on the visible parts of the skin site.
5. Participants with self-perceived pimple prone and, or sensitive skin.
6. Those with a history of current skin diseases such as psoriasis, eczema, and atopic
dermatitis.
7. Participants taking medication continuously or regularly every day such as corticosteroids or non-
steroidal anti-inflammatories, topically for four weeks or orally for eight weeks prior to the
study.
8. Participants with excessive hair, tattoos, scars, or wounds on the lateral forearm
9. Participants having chronic illness or had major surgery in the last year.
10. Participants undergo any treatment either cosmetic treatment or medical treatment of
any skin condition on face or body.
11. Participants taking any oral antibiotic medication currently or within the last 8 weeks.
12. Participants are allergic or sensitive to bar cleansing products, creams or lotions, artificial
jewellery, or anything else.
13. Participants taking medication for any condition which the Investigator believes may influence the interpretation of the data.
14. Participants have hair styles which cover half or part of the forehead. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Change in skin colour basis visual assessments (basis India Clinical Skin Colour Shade Card) and L value using CM2600D
2. Improvement in spot colour, basis visual assessments (basis India Clinical spot Colour Shade
Card) and L value using CM2600D
3. Improvement in glow/skin radiance basis visual assessment (basis Radiance/Glow Scale) |
Baseline, Instant/Immediate (Visual skin colour and glow), week 1, week 2 (visual and L value for skin and spot color only), week 4 and week 8 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Improvement in uneven skin tone basis visual assessment (basis Unilever Mottled
Hyperpigmentation scale)
2. Improvement in skin hydration/dryness levels basis visual assessments using the Unilever
Dryness scale
3. Melanin Index for skin & spot colour using CM2600D
4. Improvement in skin hydration as measured using the Corneometer CM825
5. Improvement in barrier properties (TEWL) as measured using the Vapometer SWL5
6. Improvement in barrier properties (TEWL) as measured using the Dermalab Tewameter
7. Improvement in skin tone & texture, reduction in spot/hyperpigmentation size & intensity
using VISIA Image analysis technique for parameters such as (Mottled Hyperpigmentation)
(MHP) percent - on Cheek, Blemish Coverage, LWM- CWA, Gloss Intensity. |
Baseline, (Immediate at 30mins, 8 hrs & 24hr only for Corneometer CM825 & TEWL as
measured by Vapometer & Dermalab), week 1, week 2 (VISIA assessment & Melanin index for skin & spot only), week 4 & week 8. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
In this study the skin colour (on forehead) & spots colour (on face), glow/radiance, hydration and barrier properties will be assessed visually & instrumentally at baseline and at various time points post treatment. These visual scores &/or instrumental measurements will be used to evaluate the efficacy of test products on skin and spot color as well as other attributes like even tone, hydration, glow at various timepoints as specified in this full-face product application study protocol. |