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.

NCT ID: NCT06602284

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-03-31

Brief Summary

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

Detailed Description

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Conditions

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Acne

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A single arm, full face clinical study.

Dermapen 4 in conjunction with MG-CLR serum

Group Type OTHER

Dermapen 4™

Intervention Type COMBINATION_PRODUCT

Dermapen 4™ conjunction with MG-CLR

Interventions

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Dermapen 4™

Dermapen 4™ conjunction with MG-CLR

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Equipmed USA LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Skin Wellness Dermatology

Birmingham, Alabama, United States

Site Status

Countries

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United States

Central Contacts

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Stene Marshal

Role: CONTACT

(949) 798 6207

Aahan Sachdev

Role: CONTACT

9880755883

Facility Contacts

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Jordan Rubin

Role: primary

205.678.7518

COREY LOUIS HARTMAN

Role: backup

Other Identifiers

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SKIN/EMAC/2024-01

Identifier Type: -

Identifier Source: org_study_id

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