None listed
Conditions
Interventions
Intervention1: Face Care / Soin Visage 2039174 88: Administration route: Topical usage
Galenic and packaging: emulsion in a glass pack
Investigational Product Aspect: Beige cream
Physical aspect: Beig
Sponsors
L’Oréal Research & Innovation
Eligibility
Inclusion criteria
Inclusion criteria: Healthy Indian female participants aged 20 to 60 years (both inclusive) (in case of difficulty in recruiting the participants the age can be extended to 70 years; applicable for phototypes V and VI). Participant with skin phototype ranging from III to VI according to spectrophotometer (CM-26d/CM-2600d) measurement on the unexposed area of the back on screening and baseline visit. Participants having at least one homogeneous, well-defined PIH spot of at least greater than or equal to 3mm diameter on their face using vernier caliper at screening visit and baseline visit. At least 20 participants with acne spot having clinical grading of with greater than or equal to 2 grades of contrast, greater than or equal to 2 grades of density and greater than or equal to 2 grades of size according to skin aging atlas, Asian skin type Volume 2, done by the investigator. Participant of all skin types (oily, dry, combination and normal) with minimum 15 participants having oily skin self-declared by the participants and perceived by the investigator. 50 percent of the participants having sensitive skin (self-declared). Participants agree not to undergo any permanent makeup or cosmetic surgery or apply any self-tanning tool on the investigational area during the study. Participants agree not to apply any makeup or cosmetic product on investigational area except on lips and eyes (when required). Participants agree to avoid excessive sun exposure and not to undergo any natural or artificial UV exposure during the study. Participants who are informed about the study objectives and procedures, study schedule, requirements and able to understand and comply with them. Participants willing to provide written informed consent and can read, write, and understand Hindi or English. Participants of childbearing potential must agree to undergo urine pregnancy testing. Participants of childbearing potential who are not sexually active or are using medically accepted contraceptive methods for at least one month before study initiation and throughout the study period. Accepted contraceptive methods include surgical sterilization (oophorectomy, hysterectomy, tubal ligation), oral, injectable or implant hormonal contraceptives, IUDs, condoms with spermicide, diaphragm or cervical cap with spermicide.
Exclusion criteria
Exclusion criteria: Women who are currently pregnant, breastfeeding (lactating), or planning to become pregnant during the study period. Participants who have started, stopped, or changed any hormonal treatment (such as contraceptive pills) within the last four weeks. Participants who have post-inflammatory erythema (PIE) spots, solar lentigines (sunspots), or melasma. Participants who have received any injections, undergone cosmetic surgery, or had permanent makeup on the study area within the last six months—or who are planning any such procedures during the study period. Participants who have used any depigmenting cosmetic product, or products containing retinol (or its derivatives), vitamin C (or its derivatives), or alpha/beta hydroxy acids (AHA/BHA) on the study area within one month before the study starts. Participants who have a known immune system disorder or any serious medical condition that, in the opinion of the investigator, could affect their safety during the study. Participants who have recently sunbathed, used self-tanning products, visited tanning salons, undergone phototherapy, or plan to do any of these during the study. Participants who are unable to follow study instructions or cannot be contacted in case of an emergency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of the investigational product by assessing the following parameters: • Changes in clinical grading of contrast of selected PIH spot. when compared with D0. • Changes in clinical grading of density of selected PIH spot. • Changes in the size of selected PIH spot. • Changes in the measurement (L star, a star and b star) of the selected PIH spot, the adjacent skin and one untreated and non-exposed zone (at the top of the buttock) using Spectrophotometer (CM- 26d or CM-2600d).Timepoint: at baseline, week 1, week 2, week 4, week 8, week 12, week 13, week 14 and week 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of the investigational product by assessing the following parameters: • Standard facial imaging using VISIA-CR (Standard 1, Standard 2/Raked, Cross-Polarized & Parallel- Polarized) done at D0, D28, D56 & D84 for further analysis. • Changes in the response of Self Evaluation Questionnaire (SEQ) for product efficacy & suitability at timepoints respectively D0 (Timm), D7, D14, D28, D56, D84, D91, D98 & D105. • Safety assessment of investigational product by total number of SAE, AE, LI reported throughout the study.Timepoint: at baseline, week 1, week 2, week 4, week 8, week 12, week 13, week 14 & week 15 | — |
Countries
India
Contacts
Public ContactHIRAK JYOTI NATH
CIDP Biotech India Pvt. Ltd.
Outcome results
None listed