NCT04740255

Brief Summary

This pilot study will expand knowledge and application needling using the Straberi device for the improvement of Postinflammatory Hyperpigmentation (PIH) caused by acne.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
1.9 years until next milestone

Study Start

First participant enrolled

December 23, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2023

Completed
Last Updated

December 6, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

September 15, 2020

Last Update Submit

December 4, 2023

Conditions

Postinflammatory Hyperpigmentation

Keywords

needlingpostinflammatory hyperpigmentationEpistampUniversal Skincare Institute

Outcome Measures

Primary Outcomes (1)

  • The Global Aesthetic Improvement Scale (GAIS)

    The Global Aesthetic Improvement Scale (GAIS) is a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator 5 point scale ranging from 1 to 5 with 5 = The appearance has worsen compared with the original condition and 1 = Excellent corrective results compared to pretreatment, as judged by the investigator.

    6 months

Secondary Outcomes (4)

  • Overall Skin improvement assessed by Derma Scan

    6 months

  • Overall Skin improvement assessed by Post Acne Hyperpigmentation Index (PAHPI)

    6 months

  • Photographs

    6 months

  • To evaluate the impact on the quality of life (DLQI)

    6 months

Study Arms (2)

Straberi Epistamp Needling Treatment

OTHER

Non-Randomized treatment for patients with Postinflammatory Hyperpigmentation (PIH) using the Straberi Epistamp needling.

Device: Straberi Epistamp

No Treatment

OTHER

Non-Randomized patients with Postinflammatory Hyperpigmentation (PIH)

Device: Straberi Epistamp

Interventions

Straberi EpistampDEVICE

The patient's entire face will be treated. The following settings will be used as a treatment protocol. Needle length between .02- 1.55 mm

Also known as: Microneedling
No TreatmentStraberi Epistamp Needling Treatment

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Derma Scan showing aging including skin texture, wrinkles, brown spots, and pores.
  • Patients willing to sign informed consent.
  • Patients willing to be photographed and video documented
  • Patients willing to consent to 3 months of treatment

You may not qualify if:

  • History of eczema in the treatment area; psoriasis and any other chronic skin conditions
  • History of actinic (solar) keratosis in the treatment area;
  • History of hemophilia
  • History of diabetes
  • The presence of raised moles, warts on the targeted area.
  • Collagen vascular diseases or cardiac abnormalities
  • Blood clotting problems
  • Active bacterial or fungal infection
  • Facial melanosis
  • Malignant tumors
  • Immunosuppression
  • Use of blood thinners or prednisone
  • Corticosteroids within two weeks of the procedure
  • Chronic liver disease
  • Porphyria or other skin diseases.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lavish

New York, New York, 10028, United States

Location

Related Publications (2)

  • Goodman GJ, Baron JA. Postacne scarring: a qualitative global scarring grading system. Dermatol Surg. 2006 Dec;32(12):1458-66. doi: 10.1111/j.1524-4725.2006.32354.x.

    PMID: 17199653RESULT

  • Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.

    PMID: 8033378RESULT

Related Links

MeSH Terms

Conditions

Hyperpigmentation

Interventions

Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Pigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesPuncturesRehabilitation

Study Officials

  • Maurice E Wright, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Leslie L Nesbitt

    Universal Skincare

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Participants in the Straberi by Epistamp device trial, are those who are seeking improvement for Postinflammatory Hyperpigmentation (PIH) caused by acne.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2020

First Posted

February 5, 2021

Study Start

December 23, 2022

Primary Completion

June 30, 2023

Study Completion

October 12, 2023

Last Updated

December 6, 2023

Record last verified: 2023-01

Locations

US(1)