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.
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.
1 other identifier
interventional
10
1 country
1
Brief Summary
This study is conducted to check how well the Dermapen 4™ microneedling device works with MG-CLR serum for treating acne over 12 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2024
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedSeptember 19, 2024
September 1, 2024
5 months
September 16, 2024
September 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acne severity
Change in acne severity using the modified GAGS scale at all time points when compared to baseline.
13 weeks
Study Arms (1)
A single arm, full face clinical study.
OTHERDermapen 4 in conjunction with MG-CLR serum
Interventions
Dermapen 4™ conjunction with MG-CLR
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Equipmed USA LLClead
Study Sites (1)
Skin Wellness Dermatology
Birmingham, Alabama, 35209, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2024
First Posted
September 19, 2024
Study Start
October 1, 2024
Primary Completion
March 1, 2025
Study Completion
March 1, 2025
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- protocol will be available soon after approval
- Access Criteria
- Sponsor and CRO/site personals