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NCT Number: NCT06602284

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.

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

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Skin Wellness Dermatology

Birmingham, Alabama, 35209, United States

Location contact

COREY LOUIS HARTMAN

CONTACT

Jordan Rubin

CONTACT

[email protected]

205.678.7518

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Subjects with known skin condition that may impact the assessment.
  • Subjects with active Herpes labialis infection.
  • Subjects known to have bleeding and clotting disorders (self-declared).
  • Subjects known to have connective tissue disorders.
  • Subjects with any other signs of significant local irritation or skin disease.
  • Subjects currently taking any medication, which the investigator believes may influence the interpretation of the data.

Treatment and study plan

Dermapen 4™

Combination Product

Dermapen 4™ conjunction with MG-CLR

Primary outcomes

  1. Acne severity

    Time frame: 13 weeks

    Change in acne severity using the modified GAGS scale at all time points when compared to baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Aahan Sachdev

CONTACT

[email protected]

9880755883

Stene Marshal

CONTACT

[email protected]

(949) 798 6207

Sponsors and collaborators

Lead sponsor

Equipmed USA LLC

Industry

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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