Postinflammatory HyperpigmentationEPHNCT04740255
Straberi Epistamp Device for Postinflammatory Hyperpigmentation
A study testing Straberi Epistamp in people with Postinflammatory Hyperpigmentation, run by Universal Skincare Institute at 1 site in United States.
Trial summary
This pilot study will expand knowledge and application needling using the Straberi device for the improvement of Postinflammatory Hyperpigmentation (PIH) caused by acne. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postinflammatory Hyperpigmentation
- What is being tested?
- Straberi Epistamp
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2022to 12 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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.
- Patient not willing to sign informed consent.
- TCA peels in the last 5 weeks
- Subject currently has moderate to severe acne on the face.
- Microneedling within the last 6 months
- Subject has an active infection.
- Subject has a history of a bleeding disorder
- Subject has a history of keloidal tendency
- Subject has received ablative or non-ablative laser treatments in the previous 6 months.
- Subject has taken Accutane within the previous 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial Study for the Use of Straberi Epistamp Needling Device to Treat Postinflammatory Hyperpigmentation (PIH)
This pilot study will expand knowledge and application needling using the Straberi device for the improvement of Postinflammatory Hyperpigmentation (PIH) caused by acne.
Read the detailed description
This pilot study will expand the knowledge and application of needling using the Straberi Epistamp device and its safety and benefits for improving the appearance of Postinflammatory Hyperpigmentation. Postinflammatory Hyperpigmentation (PIH) caused by acne is a common inflammatory disease that can adversely affect facial appearance. Facial acne can have a serious negative impact on psychosocial functioning leaving deep emotional scars. Severe acne can also lead to physical scars and disfigurement. Among patients with severe acne, facial scarring affects both genders equally and occurs to some degree in 95% of cases.
- Conditions
- Postinflammatory Hyperpigmentation
- Being tested
- Straberi Epistamp
- Keywords
- needling, postinflammatory hyperpigmentation, Epistamp, Universal Skincare Institute
- Medical subject headings
- Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Straberi EpistampDevice
Also called Microneedling
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
| Study group | Role | What they receive |
|---|---|---|
| Straberi Epistamp Needling Treatment | Other | Non-Randomized treatment for patients with Postinflammatory Hyperpigmentation (PIH) using the Straberi Epistamp needling. Receives: Device: Straberi Epistamp |
| No Treatment | Other | Non-Randomized patients with Postinflammatory Hyperpigmentation (PIH) Receives: Device: Straberi Epistamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
Overall Skin improvement assessed by Derma Scan
The Derma Scan System utilizes two special lighting systems (RGB +UV) and smart skin analyzer software that allows two images (before and after care) to be compared side by side, which can be used to detect the changes in skin
Measured: 6 months
Overall Skin improvement assessed by Post Acne Hyperpigmentation Index (PAHPI)
The parameters of the scoring method are: median lesion size (S) (<3mm, 3-6, 7-10, and >10mm scored as 2, 4, 6, and 8, respectively), median lesion intensity (I) (slightly or moderately or significantly darker than surrounding skin scored as 3, 6, and 9, respectively), and number of lesions (N) (1-15, 16-30, 31-45, 46-60, and >60 scored as 1-5, respectively). The score range from the total of S+I+N=6-22.
Measured: 6 months
Photographs
Digital imaging device using a grid background with controlled lighting and setting to grade acne scar improvement on a quartile grading scale(1 = 1% to 25%, 2 = 26 to 50%, 3 = 51 to 75%, 4 = >76% improvement).
Measured: 6 months
To evaluate the impact on the quality of life (DLQI)
The Dermatology Life Quality Index questionnaire (DLQI) is 10 questions were asked to the patients and score is 0-3 for each question. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start23 Dec 2022
- Primary completion30 Jun 2023
- Study completion12 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postinflammatory HyperpigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Participants in the Straberi by Epistamp device trial, are those who are seeking improvement for Postinflammatory Hyperpigmentation (PIH) caused by acne.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universal Skincare Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Lavish Beauty
- Responsible party
- Sponsor
- Investigators
- Maurice E Wright, MD, Principal investigator, Columbia UniversityLeslie L Nesbitt, Study chair, Universal Skincare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740255
- Sponsor's protocol ID
- 1115
- Acronym
- EPH
- Status last verified
- Jan 2023
- First submitted
- 15 Sep 2020
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Once the overall trial is completed and sensitive detailed information is legally advised to published.
Publications
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.
PubMed 17199653Finlay 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.
PubMed 8033378
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Study for the Use of Straberi Epistamp Needling Device to Treat Postinflammatory Hyperpigmentation (PIH)
- ClinicalTrials.gov ID
- NCT04740255
- Acronym / sponsor ID
- EPH / 1115
- Conditions
- Postinflammatory Hyperpigmentation
- Keywords
- needling, postinflammatory hyperpigmentation, Epistamp, Universal Skincare Institute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universal Skincare InstituteUniversity, hospital or other
- Collaborators
- Lavish Beauty
- Study start
- 23 Dec 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 12 Oct 2023 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study will expand knowledge and application needling using the Straberi device for the improvement of Postinflammatory Hyperpigmentation (PIH) caused by acne.
Detailed description
This pilot study will expand the knowledge and application of needling using the Straberi Epistamp device and its safety and benefits for improving the appearance of Postinflammatory Hyperpigmentation. Postinflammatory Hyperpigmentation (PIH) caused by acne is a common inflammatory disease that can adversely affect facial appearance. Facial acne can have a serious negative impact on psychosocial functioning leaving deep emotional scars. Severe acne can also lead to physical scars and disfigurement. Among patients with severe acne, facial scarring affects both genders equally and occurs to some degree in 95% of cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants in the Straberi by Epistamp device trial, are those who are seeking improvement for Postinflammatory Hyperpigmentation (PIH) caused by acne.
| Arm | Type | Receives |
|---|---|---|
| Straberi Epistamp Needling Treatment | Other | Device: Straberi EpistampNon-Randomized treatment for patients with Postinflammatory Hyperpigmentation (PIH) using the Straberi Epistamp needling. |
| No Treatment | Other | Device: Straberi EpistampNon-Randomized patients with Postinflammatory Hyperpigmentation (PIH) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Straberi EpistampAlso: MicroneedlingThe patient's entire face will be treated. The following settings will be used as a treatment protocol. Needle length between .02- 1.55 mm | Device | No Treatment, Straberi Epistamp Needling Treatment |
Primary outcome
The Global Aesthetic Improvement Scale (GAIS)
Time frame: 6 months
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.
4 secondary outcomes
Overall Skin improvement assessed by Derma Scan
Time frame: 6 months
Overall Skin improvement assessed by Post Acne Hyperpigmentation Index (PAHPI)
Time frame: 6 months
Photographs
Time frame: 6 months
To evaluate the impact on the quality of life (DLQI)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Results publication: PubMed 17199653Goodman 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.
- Results publication: PubMed 8033378Finlay 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.
- Description Derma ScanLink provided by the sponsor.
- Description Acne Scars SubtypesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Once the overall trial is completed and sensitive detailed information is legally advised to published.
Related trials for Postinflammatory Hyperpigmentation
Not yet recruiting
A Single-Center, Open-Label Study to Assess the Efficacy and Tolerability of a Brightening Serum in Skin of Color Patients With Post Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
Recruiting
A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants
Post-inflammatory Hyperpigmentation, Melasma
Recruiting
Study on the Functional Impact of Cosmetics on Improving Self-Esteem and Quality of Life in Black Women
Post-inflammatory Hyperpigmentation
Not yet recruiting
Evaluation of Efficacy and Tolerabilty of MelaB3 Serum in Combination of 35% Glycolic Acid Peeling Compared to 35% Glycolic Acid Peeling Alone in Various Hyperpigmentation Conditions
Hyperpigmentation, Melasma
Recruiting
Fractionated 1927-nm Non Ablative Thulium Laser in Treating Post Inflammatory Hyperpigmentation
Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurice E Wright, MD principal investigator
Columbia University
Leslie L Nesbitt study chair
Universal Skincare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Straberi Epistamp in people with Postinflammatory Hyperpigmentation, run by Universal Skincare Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Global Aesthetic Improvement Scale (GAIS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04740255, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.