None listed
Conditions
Interventions
Intervention1: AP Serum: Apply a thin coat of the serum on full face, focusing on the melasma area in the morning and evening.
Intervention2: AP Daycare Cream: Dispense the 1 Finger-tip unit of cream
Sponsors
Beiersdorf AG
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female subjects aged between 18-50 years (both ages inclusive) 2. Fitzpatrick skin phototype III to VI. 3. Subjects presenting with moderate to severe melasma (based on IGA) and intention to treat. 4. Subjects who have not used any depigmenting agent or undergone any melasma treatment in the past 4-6 weeks as per dermatologists’ discretion. 5. Subjects willing to stop all other skin care products usage on the test site and diligently follow the provided treatment plan. 6. Subject free of excessive hair, cuts, abrasions, fissures, wounds, lacera-tions, or any other skin conditions on the face. 7. Subjects who agree not to use any other product/treatment/home remedy/ except the provided products on their face during the study period. 8. Subjects who agree not to carry out bleaching or any other procedures in-cluding facial etc. on face during the study period. 9. Subjects who agree not to expose to excessive sun light. (Sun exposure not more than half an hour daily and during that time use of an umbrella to cover face). 10. Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up. 11. Subjects willing to abide by and comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Subject with any other signs of significant local irritation or skin disease. 2. Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study. 3. Subjects on hormonal therapy (contraceptive, TSH) for at least 6 months prior to the study. 4. Subjects who are pregnant/ nursing (self-declared) or have plans of becoming pregnant during the study. Pregnancy in subjects of child bearing potential will be confirmed by urine pregnancy test. 5. 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. 6. Subjects using corticosteroids or under antiepileptic medications for the previous six months. 7. Subjects with a history of any other dermatosis of the face or known photo-sensitivity or undergoing topical treatment with sun protection factor in the past 1 month. 8. 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, 9. Subjects with any other active skin condition that may interfere with the study results. 10. Subjects with a known history of allergenic reactions to any components of the products. 11. Subjects who have participated in any other clinical trial in the last 3 months. 12. Subjects with inadequate language proficiency (spoken and written). 13. Subject’s inability to be placed in the photography system. 14. Subjects with severe psychological illness or intellectual inability to understand the study. 15. Employees of the CRO or the Sponsor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Change in mMASI and IGA scores at all time points after treatment using Eucerin® Anti-Pigment regimen and non-ablative LASER therapy (ALMA ClearSkin Er:Glass 1540nm) when compared to baseline(TB1 and TB2). •Change in the appearance of melasma using dermatological visual grading scores at all time points after treatment using Eucerin® Anti-Pigment regimen and non-ablative LASER therapy (ALMA ClearSkin Er:Glass 1540nm) when compared to baseline (TB1 and TB2). •Change in the appearance of melasma using VISIA CR at all time points after treatment using Eucerin® Anti-Pigment regimen and non-ablative LASER therapy (ALMA ClearSkin Er:Glass 1540nm) when compared to baseline (TB1 and TB2). •percentage change from baseline based on Spectrophotometer L for pigmentation.Timepoint: baseline 1, baseline 2, 4 days after baseline 2, week 2, week 4, week 8, week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| •Change in mMASI and IGA scores at all time points before and after treatment using Eucerin® Anti-Pigment regimen and non-ablative LASER therapy (ALMA ClearSkin Er:Glass 1540nm) when compared to control. •Change in the appearance of melasma using dermatological visual grading scores at all time points before and after treatment using Eucerin® Anti-Pigment regimen and non-ablative LASER therapy (ALMA ClearSkin Er:Glass 1540nm) when compared to control. •Change in MelasQoL status, ELQI status, self-assessment questionnaire at all time points in comparison to baseline (TB1 and TB2) and control group. Timepoint: baseline 1, baseline 2, 4 days after baseline 2, week 2, week 4, week 8, week 12. | — |
Countries
India
Contacts
Public ContactSudhanthiran S
MS Clinical Research Pvt. Ltd.
Outcome results
None listed