CTRI/2024/08/072306
Not yet recruiting
Phase 2
A full face, baseline controlled study to evaluate the efficacy of Dermapen 4™ microneedling device in conjunction with MG-CLR serum for acne 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
- •Female subjects aged between 18\-45 years (both ages inclusive).
- •Fitzpatrick skin phototype I to VI.
- •Subjects having IGA score of 2 and 3\.
- •Subjects who have not received any kind of treatment for acne 1 month before the start of the study.
- •Subject free of excessive hair, cuts, abrasions, fissures, wounds, lacerations, or any other skin conditions on the face.
- •Subjects who agree not to use any other product/treatment/home remedy/except the provided products on their face during the study period.
- •Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period.
- •Subjects who agree not to expose to excessive sunlight. (Sun exposure not more than two hours daily and during that time use of an umbrella to cover the face).
- •Subjects willing to give a voluntary written informed consent, photography release, and agree to come for regular follow\-up.
- •Subjects willing to abide by and comply with the study protocol.
Exclusion Criteria
- •1\.Subjects with known skin condition that may impact the assessment.
- •2\.Subjects with active Herpes labialis infection.
- •3\.Subjects known to have bleeding and clotting disorders (self\-declared).
- •4\.Subjects known to have connective tissue disorders.
- •5\.Subjects with any other signs of significant local irritation or skin disease.
- •6\.Subjects currently taking any medication, which the investigator believes may influence the interpretation of the data.
- •7\.Subjects having clinically significant systemic or cutaneous disease, chronic illness or major surgery in the last year.
- •8\.Subjects undergoing treatment of any skin condition on their face.
- •9\.Subjects not willing to discontinue other topical facial products.
- •10\.Subjects who are allergic or sensitive to bar cleansing products, cosmetics, creams/lotions, artificial jewelry or anything else.
Outcomes
Primary Outcomes
Not specified
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