None listed
Conditions
Interventions
Intervention1: 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 participan
Sponsors
Hindustan Unilever Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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).
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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)Timepoint: 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
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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. | — |
Countries
India
Contacts
Public ContactMs Preetha Paul
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.
Outcome results
None listed