Reduction in Symptoms After Laser Therapy With Acorn aHFS | NCT06336135

Studies
Reduction in Symptoms After Laser Therapy With Acorn aHFS

NCT06336135

Sponsor

Acorn Biolabs Inc.

Status

Completed

Last Update Posted

Dec 12, 2025Actual

Enrollment

11Actual

Phase

Not provided

Conditions

Skin Aging

Interventions

autologous hair follicle derived secretome

Countries

Canada

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

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 25, 2024Actual

Primary Completion Date

Dec 2, 2025Actual

Completion Date

Dec 2, 2025Actual

First Submitted Date

Mar 22, 2024

First Submission Date that Met QC Criteria

Mar 22, 2024

First Posted Date

Mar 28, 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

Dec 5, 2025

Last Update Posted Date

Dec 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study evaluates the severity and duration of symptoms experienced after laser therapy comparing four post-procedure topical products. Each product is applied to an individual region of interest (5 cm diameter) on the back or décolleté according to randomization code after laser therapy. The subject, blind to the product applied to each of 4 regions of interest, assesses eight symptoms daily for 14 days. Photography is performed daily.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
autologous hair follicle derived secretome	Other	aHFS is a cosmetic topical intended to be applied to the human body after skin resurfacing cosmetic procedures. aHFS is produced from the plucked hair follicles of each individual, making it autologous.		Acorn autologous hair follicle secretome aHFS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in severity and duration of symptoms	Each region of interest will be evaluated daily for the severity and duration of eight symptoms	2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or Female
Age: ≥18 and ≤60 years
Any skin tone Fitzpatrick score 1-2 (light), 3-4 (medium), 5-6 (dark)
Competent and willing to provide written, informed consent to participate in all study activities

Exclusion Criteria:

Pregnant women
Are participating/have participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by Sponsor
Use of retinoids 7 days prior to the procedure
Active cutaneous infections in the treatment area
Diseases that could inhibit healing, such as scleroderma, or other cutaneous conditions that could confound study results
Subjects unable to communicate with the investigator and staff
Any health condition that in the investigator's opinion should preclude participation in this study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Subjects are healthy adults receiving laser skin rejuvenation therapy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lisa Campbell, PhD	Acorn Biolabs Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rejuuv Medi Spa		Markham	Ontario	L3R0M3	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participant data will not be made available.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided