None listed
Conditions
Interventions
Intervention1: Dermapen 4™ microneedling device in conjunction with MG-BL serum.: Treatment using Dermapen 4™ microneedling device in conjunction with MG-BL serum will be provided at baseline, week 2,
Sponsors
Equipmed USA LLC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Fitzpatrick skin phototype I to VI. 2. Subjects presenting with moderate facial Melasma. 3. Subjects who have not used any depigmenting agents or undergone any melasma treatment in the past 4-6 weeks as per dermatologists’ discretion. 4. Subjects willing to stop all other skin care products usage on the test site and diligently follow the provided treatment plan. 5. Subject free of excessive hair, cuts, abrasions, fissures, wounds, lacerations, or any other skin conditions on the face. 6. Subjects who agree not to use any other product/treatment/home remedy/ ex-cept the provided products on their face during the study period. 7. Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period. 8. Subjects who agree not to expose to excessive sun light. (Sun exposure not more than two hours daily and during that time use of umbrella to cover face). 9. Subjects willing to give a voluntary written informed consent, photography re-lease and agree to come for regular follow-up. 10. Subjects willing to abide by and comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Subjects with other known skin condition that may impact the assessment. 2. Subjects with any active infectious condition (eg. Herpes labialis). 3. Subjects known to have bleeding and clotting disorders (self-dec 4. Subjects known to have connective tissue disorders. 5. Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study. 6. Subjects on hormonal therapy or were on hormonal therapy for past 2 months. 7. Subjects with any other signs of significant local irritation or skin disease. 8. Subjects currently taking any medication, which the investigator believes may influence the interpretation of the data. 9. Subjects using corticosteroids. 10. Subjects having clinically significant systemic or cutaneous disease, chronic illness or major surgery in the last year. 11. Subjects undergoing treatment of any skin condition on their face. 12. Subjects who are allergic or sensitive to bar cleansing products, cosmetics, creams/lotions, artificial jewelry or anything else. 13. Subjects who have participated in a similar clinical study 8 weeks before this study. 14. Subjects who are pregnant or nursing. (Self-declared) 15. Subjects with skin allergy history or atopic dermatitis or psoriasis. 16. Subject who are on any medication like blood thinners. 17. Subject is an employee of the sponsor or the CRO.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Dermapen 4™ microneedling device in conjunction with the MG-BL serum using the mMASI score at all time points in comparison to baseline.Timepoint: baseline, week 2, week 4, week 6, week 8 and week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the efficacy of Dermapen 4™ microneedling device in conjunction with the MG-BL serum using the IGA of melasma severity score and IGAI score at all time points in comparison to the baseline. 2. To evaluate the efficacy of Dermapen 4™ in conjunction with MG-BL serum using self-assessment questionnaire and MelasQoL questionnaire. 3. To evaluate the satisfaction of Dermapen 4™ in conjunction with MG-BL serum using subject satisfaction qestionnaire. Timepoint: baseline, week 2, week 4, week 6, week 8 and week 12. | — |
Countries
India, United States of America
Contacts
Public ContactDr Mukta Sachdev
MS Clinical Research Pvt. Ltd.
Outcome results
None listed