A Full Face Study to Evaluate the Efficacy of Dermapen 4™... | NCT06602284

Studies
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.

NCT06602284

Sponsor

Equipmed USA LLC

Status

Not yet recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

10Estimated

Phase

Phase 2Phase 3

Conditions

Acne

Interventions

Dermapen 4™

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2024Estimated

Primary Completion Date

Mar 2025Estimated

Completion Date

Mar 2025Estimated

First Submitted Date

Sep 16, 2024

First Submission Date that Met QC Criteria

Sep 16, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2024

Last Update Posted Date

Sep 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A single arm, full face clinical study.	Other	Dermapen 4 in conjunction with MG-CLR serum	Combination Product: Dermapen 4™

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dermapen 4™	Combination Product	Dermapen 4™ conjunction with MG-CLR	A single arm, full face clinical study.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acne severity	Change in acne severity using the modified GAGS scale at all time points when compared to baseline.	13 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stene Marshal	Contact	(949) 798 6207		stene@dermapenworld.com
Aahan Sachdev	Contact	9880755883		aahan.sachdev@msclinical.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Skin Wellness Dermatology		Birmingham	Alabama	35209	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol

Time Frame

protocol will be available soon after approval

Access Criteria

Sponsor and CRO/site personals

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000152	Acne Vulgaris

Ancestor Terms

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

Browse Leaves

Not provided

Browse Branches

Not provided