None listed
Conditions
Interventions
Intervention1: Anti-Pigment Dual Serum: Apply a thin coat of Test regimen on the full face,
primarily focusing on the melasma area both in the morning and
evening.
Intervention2: Anti-Pigment Day SP
Sponsors
Beiersdorf AG
Eligibility
Inclusion criteria
Inclusion criteria: Adult subjects in general good health as determined from recent medical history, general physical examination, dermatological assessment, Subjects of Phototype from III to VI. Subjects diagnosed with mild to moderate Melasma, Subjects who have not used contraindicated products (irritants, other depigmenting agents) in the past 8 weeks (as per the treatment category, as per dermatologists’ discretion, Subjects willing to stop all other skin care products and diligently follow the pro vided treatment plan, Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face, Subject who agrees not to use any other product/treatment/home remedy/ except the provided products on their face during the study period other than the test reg imen, Subjects who agree not to carry out bleaching or any other procedures including facial etc. on the face during the study period, Subjects who agree not to be exposed to excessive sunlight. (Sun exposure not more than half an hour daily and during that time use of an umbrella to cover face), Subjects willing to give a voluntary written informed consent, photography re lease and agree to come for regular follow-up, Subjects willing to abide by and comply with the study protocol. Willing to sign a photography release In case of hormonal treatment/contraception, subjects who have been on a stable dose for at least 6 months and agree not to change or stop their treatment/ contraception medication/dose
Exclusion criteria
Exclusion criteria: Subject with any other signs of significant local irritation or skin disease, Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study, Subjects on hormonal therapy (contraceptive, TSH) for at least 6 months prior to the study. Subjects who are pregnant or breastfeeding (self-declared). Subjects with childbearing potential or have plans of pregnancy (excluded by a urine pregnancy test). Subjects who recently had a skin-lightening procedure in the past 8 weeks or oral photosensitizers or who underwent phototherapy in the past 1 month wash out. Subjects using corticosteroids or under antiepileptic medications for the previous six months. Subjects with a history of any other dermatosis of the face or known photosensi tivity or undergoing topical treatment with Sun Protection Factor in the past 1 month. Subjects who are exposed to the sun on a regular basis, frequent tanning salons or foresee exposure to the sun during the study or any facial procedure planned during the course of the study, Subjects with any other active skin condition that may interfere with the study re sults. Subjects with a known history of allergenic reactions to any components of the products. Subjects who have participated in any other clinical trial in the last 3 months. Subjects with Inadequate language proficiency (spoken and written) Subject’s Inability to be placed in the photography system Subjects with Severe psychological illness or intellectual inability to understand the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mMASI and change from Baseline ? Change in Investigator Global Assessment, in terms of the proportion of subjects across the 5-point IGA scores. ? Change from Baseline based on instrumental assess ment for pigmentationTimepoint: baseline at weeks 2,4,8, and 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject Self-grading, in terms of raw value for each question Quality of Life by MelasQol questionnaire, in terms of raw value, change, and change from Baseline of total score. Eucerin Life Quality Index questionnaire. Evaluation of the local tolerance and adverse events in relation to the investigational products during the study using a sub ject diary and a severity scaleTimepoint: baseline at weeks 2,4,8, and 12. | — |
Countries
India
Contacts
Public ContactSudhanthiran S
MS Clinical research
Outcome results
None listed