None listed
Conditions
Interventions
Intervention1: Dermapen 4™ microneedling device with MG-CLR serum: Treatment using Dermapen 4™ microneedling device with MG-CLR serum will be provided at baseline, week 2, week 4 and week 6 to evaluat
Sponsors
Equipmed USA LLC
Eligibility
Inclusion 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
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. 11.Subjects who have participated in a similar clinical study 4 weeks before this study. 12.Subjects who are pregnant or nursing (self-declared). 13.Subjects with skin allergy history or atopic dermatitis or psoriasis. 14.Subjects who are on any kind of supplements or taking nutraceuticals. 15.Subject who are on any medication like blood thinners, excessive hormonal acne, cystic acne. 16.Subject is an employee of the sponsor or the CRO.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in acne severity using the modified GAGS scale at all time points when compared to baseline.Timepoint: Baseline, week 2, week 4, week 6 and week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in the following at all time points when compared to baseline: a. acne count b. IGA score c. IGAI scores. 2.To prove that Dermapen 4™ in conjunction with MG-CLR serum does not aggravate acne severity in subjects with active acne lesions 3. Subject self-assessment of active acne status change at all time points and baseline. 4. Subject satisfaction at week 12 post treatment with Dermapen 4 in conjunction with MG-CLR treatments.Timepoint: Baseline, Week 2, Week 4, week 6 and week 12. | — |
Countries
India, United States of America
Contacts
Public ContactDr Mukta Sachdev
MS Clinical Research Pvt. Ltd.
Outcome results
None listed