Health Condition 1: L814- Other melanin hyperpigmentation
Conditions
Interventions
Intervention1: SHNI Cream: A thin coat (pea sized) of SHNI Cream to be applied topically to full face once a day for 3 months.
Control Intervention1: NIL: NIL
Sponsors
SHNI Ventures LLP
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1)Female and male patients, from 18-45 years of age with epidermal melasma. 2)Subjects with mild to moderate epidermal melasma. 3)Participants who can provide a written informed consent and photo consent form. 4)Participants who are willing to follow up for four visits over a period of 12 weeks. 5)Participants who are able and willing to follow all the study procedures including abstinence from usage of any OTC product related to face applications. 6)Participants who are willing to be clinically photographed as per protocol.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1)Patient who is not willing to participate in the study. 2)Patients who are using other pigment reduction creams (except sunscreen and a base moisturiser). 3)Subjects with other dermatological disorder of the face that may interfere with the study evaluation (Acne, DPN, Seborrheic melanosis) 4)Subjects with known hypersensitivity to any of the study compunds or constituents. 5)Subjects who are expected to be exposed to the triggering factors (excessive sun exposure, UVB photo therapy, use of OCPs). 6)Patient who has received facial procedures like dermabrasion, chemical peels, or laser procedures within the last 1 month. 7)Any patient as per investigator’s opinion is unfit for participation in the study. 8)Pregnant / lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate improvement in modified Melasma Area and Severity Index (mMASI) score.Timepoint: Month 0, Month 1, Month 2, Month 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in subject’s quality of life by Melasma Quality of Life survey.Timepoint: Month 1 & 3;Improvement in Tone HomogeneityTimepoint: Month 0 to Month 3;Mean change in Melanin & Erythema Indices.Timepoint: Month 0 to Month 3.;Mean change in mMASI scores.Timepoint: Month 0 to Month 3;Subject perceived efficacy by Patient Global Assessment.Timepoint: Month 3 | — |
Countries
India
Contacts
Public ContactPrashanti Patil
SHNI Ventures LLP
Outcome results
None listed