CTRI/2024/08/072185
Not yet recruiting
Phase 2
A full-face baseline controlled study to evaluate the efficacy of Dermapen 4™ microneedling device in conjunction with MG-BL serum for melasma treatment over 12 weeks - NI
Equipmed USA LLC0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Equipmed USA LLC
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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