None listed
Conditions
Interventions
Intervention1: Facial cleanser
Day cream (SPF)
Spot serum
Night gel: Facial cleanser:1gm on full face and twice daily (morning and evening)for 8 weeks i.e. 56 days
Day cream: 1gm on full face once d
Sponsors
Unilever Industries Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female participants between 20 27 years (both inclusive) and between 37 45 years of age (both inclusive) 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 7.25 (as per Unilever India Clinical Skin Colour Shade Card). 2 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. Participants have about 3 spots (freckles/solar Lentigines/senile lentigines/PIH post acne) on full face, among these, at least one spot should have a diameter of 3 mm, while the remaining two spots should each have a diameter of 2 mm. A minimum of 30 spots needed for each spot type out of 180 spots per full face: (per age group) a. 30 spots of Freckles to complete b. 30 spots of Solar lentigines/sunspots to complete c. 30 spots of PIH d. Remaining spots can be of any of the spot type. 2. Please note If cases where an adequate number of solar lentigines spots are not identified in the younger age group, the distribution of spots across the age groups will be discussed with the sponsor 3. Please note In cases where some participants have fewer than three spots or lack certain spot types, they may still be included following discussion with the sponsor. a. Priority 1 L spot colour The spot types (30 nos per type) will be matched across the 2 age groups. The mean baseline spot colour of younger group will be 1 L lighter (or more) than the mean baseline of middle-aged group. b. Priority 2 L skin colour The mean baseline skin colour of young group will be minimum 4. 0.5 L lighter (or more) than the baseline of middle-aged groups. 5. It is essential to ensure that the 1 L spot colour and 0.5 L skin colour age difference between the age groups is retained. 6. Participants will be selected to have a range of forehead skin brightness (L) as follows: a. 50 55 = 50 of participants b. 46 49 = 25 of participants c. 40 45 and 56 60 65 remaining 25 7. These criteria will be adjusted slightly to manage the different baselines for the 2 age groups. 8. Very large patches/ unevenness on face to be avoided. 9. Participants with mild to moderate dark circles. (1 6.5 as per UEDC scale) 10. Participants with forehead fine lines below grade 2 (only dynamic lines with movement) for age younger age group (Age 20 27 years) and 2 and 4 for middle age group (Age 37 to 45years) early static lines, moderate depth using Skin Aging atlas by Bazin & Flament vol 4 Indian type 11. Participants with cheek fine lines below grade 2 (only dynamic lines with movement for age younger age group (Age 20-27 years) and 2 and 4 for middle age group (Age 37 to 45years) early static lines, moderate depth using Skin Aging atlas by Bazin & Flament vol 4 Indian type by Bazin Flament vol 4 Indian type 12. Participants with clinical grading of Skin Smoothness 3 (mild) for age younger age group (Age 20 27 years) and 3 and 6 (moderate) for middle age
Exclusion criteria
Exclusion criteria: 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 are 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. Those with a history of current skin diseases such as psoriasis, eczema, and atopic dermatitis. 6. Those who have used anti-inflammatory drugs such as corticosteroids orally or externally within the past 1 month. 7. Participants with known skin allergies to any skin brightening actives, e.g., resorcinol derivatives. 8. Participants with self-perceived pimple prone or sensitive skin. 9. Participant with tattoos on forearms. 10. Participants had chronic illness or had major surgery in the last year. 11. Participants undergo any treatment either cosmetic treatment or medical treatment of any skin condition on face body. 12. Participants are taking any oral antibiotic medication currently or within the last 8 weeks. 13. Participants taking medication continuously regularly every day such as corticosteroids or non-steroidal anti-inflammatories, topically for four weeks or orally for eight weeks prior to the study 14. Participants are allergic or sensitive to bar cleansing products, creams lotions, artificial jewellery, or anything else. 15. Female participant pregnant breast feeding or planning pregnancy during the study period (self-declaration by the participants on screening visit and confirmed by Pregnancy test on baseline visit (visit 2) 16. Participants taking medication for any condition which the Investigator believes may influence the interpretation of the data. 17. Participants have hair styles which cover half part of the forehead. 18. Does the participant have any known allergy to resorcinol derivatives (Clearasil cream, acnorm lotion, Onak SR lotion, Cureac lotion, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of over all skin appearance which would be evaluated by visual assessment and instrumental measurementsTimepoint: Visual assessments and instrumental measurements will be done on Day 1 (T0 and Timm); Day 8; Day 15; Day 29 and Day 57 | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory objective for facial photography by VISIA CRTimepoint: Day 1 (T0 and Timm); Day 8; Day 15; Day 29 and Day 57 | — |
Countries
India
Contacts
Public ContactDr Sneha Sonker
CIDP Biotech India Pvt. Ltd
Outcome results
None listed