A Full Face Study to Evaluate the Efficacy of Dermapen 4™ Microneedling Device in Addition with MG-CLR Serum for Acne Treatment Over 12 Weeks.

Equipmed USA LLC

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Acne

Treatments: Combination Product: Dermapen 4™

Study type: Interventional

Funder types: Industry

Identifiers

NCT06602284

SKIN/EMAC/2024-01

Details and patient eligibility

About

This study is conducted to check how well the Dermapen 4™ microneedling device works with MG-CLR serum for treating acne over 12 weeks.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Female subjects aged between 18-45 years (both ages inclusive)
2. Fitzpatrick skin phototype I to VI.
3. Subjects having IGA score of 2 and 3.
4. Subjects who have not received any kind of treatment for acne 1 month before the start of the study.
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/ except the provided products on their face during the study period

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

A single arm, full face clinical study.

Other group

Description:

Dermapen 4 in conjunction with MG-CLR serum

Treatment:

Combination Product: Dermapen 4™