Health Condition 1: L819- Disorder of pigmentation, unspecified
Conditions
Interventions
Intervention1: An open label single arm non-comparative study to assess the effectiveness and safety of Melaglow Day and Night cream (combi kit) in the treatment of epidermal hyperpigmentation.
Melag
Sponsors
CUTIS Academy of Cutaneous Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female patients, between 18-45 years of age, with epidermal hyperpigmentation. 2.Participants able to provide a written informed consent 2.Participants willing to follow up for three visits over a period of 12 weeks (approximately). 3.Participants able and willing to follow all the study procedures including abstinence from usage of any OTC product related to face applications. 3.Participants willing to be clinically photographed as per protocol
Exclusion criteria
Exclusion criteria: 1.Patient not willing to participate in the study or comply with any study procedures / requirements. 2.Patients using other pigment reduction creams. 3.Patients with other dermatological disorder of the face that may interfere with the study evaluation (Acne, Dermatosis Papulosa Nigra (DPN), Melasma, Seborrheic melanosis) 4.Patients with known hypersensitivity to any of the study drugs or constituents. 5.Patients expected to be exposed to the triggering factors during the course of study. (excessive sun exposure, UVB photo therapy, use of oral contraceptive pills (OCPs) 6.Patient who received facial procedures like dermabrasion, chemical peels or laser procedures within the last 1 month. 7.History of or ongoing thyroid disorder 8.Any patient as per investigatorâ??s opinion is unfit for participation in the study. 9.Pregnant / lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect assessed in terms of reduction in epidermal pigmentation assessed clinically, dermoscopically and by using Fotofinder.Timepoint: After 3 months of using the product | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Patients satisfaction with treatment will be assessed based on a Grading questionnaire 2.Safety will be assessed based on the ADR reported during the study period. 3.Patient compliance will be assessed based on completed patient diary and compliance assessment during study visitsTimepoint: after 3 months of using the product | — |
Countries
India
Contacts
Public ContactDr BS Chandrashekar
CUTIS Academy of Cutaneous Sciences
Outcome results
None listed