HealthyNCT06149780
Fractionated 1927-nm Non Ablative Thulium Laser in Treating Post Inflammatory Hyperpigmentation
A study testing Patients treated with laser in people with Healthy, run by Henry Ford Health System at 1 site in United States.
Trial summary
To study the effect of fractionated 1927-nm non ablative thulium laser in reduction of post inflammatory hyperpigmentation (PIH) using a validated and reproducible model for studying PIH. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Patients treated with laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient age 18 and older
- Patient with skin phototypes IV-VI
- Patient able to understand requirements of the study and risks involved
- Patient able to sign a consent form
- Patient to have discontinued all oral medications used to treat pigmentary abnormalities and all topical medications, except for sunscreen, used to treat pigmentary abnormalities on the buttocks one month prior to treatment
Who cannot join
- A patient who has skin dyspigmentation, birth marks, tattoos, or other skin findings at baseline on either buttock that may obscure study results
- A patient who is lactating, pregnant, or planning to become pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Henry Ford Medical Center
Detroit, Michigan, 48202
Fanar Razoky, Bachelors, 313-694-1923, Frazoky1@hfhs.org
Mohammad Tasneem, MD
About this study
Official title: Efficacy and Safety of the Fractionated 1927-nm Non Ablative Thulium Laser in Treating Post Inflammatory Hyperpigmentation in Skin Phototypes IV-VI
To study the effect of fractionated 1927-nm non ablative thulium laser in reduction of post inflammatory hyperpigmentation (PIH) using a validated and reproducible model for studying PIH.
- Determine if there is aa reduction in PIH in patients treated with three (3) monthly sessions of fractionated 1927-nm non ablative thulium laser
- Determine if there is efficacy of post-procedure clobetasol propionate 0.05% ointment in the management of PIH
- Determine the histological and molecular changes that occur with laser and laser plus topical steroid treatment compared to untreated skin
Read the detailed description
The design of the study consists of a total of six visits including one initial screening visit within 107-127 days depending on the scheduling of your screening and subsequent visits. Assessments such as visual examination, photography, Investigatory Global Assessment (IGA) of pigmentation and erythema; Colorimetry; and Diffuse Reflectance Spectroscopy of the intended treatment area will be conducted at Visits 1-5. Optional biopsies will be taken at various time points.
- Conditions
- Healthy
- Being tested
- Patients treated with laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients treated with laserDevice
Patients treated with laser with topical steroid Patients treated with laser with vehicle
| Study group | Role | What they receive |
|---|---|---|
| Fractional laser patients treated with laser | Experimental | Laser with topical steroid and laser with vehicle. Receives: Device: Patients treated with laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Pigmentation in all 5 subjects
Measured clinical with IGA objectively with colometry
Measured: Visit 1 (Day 0) through Visit 5 (Day 112 ±5)
Secondary outcomes (2)
Immunohistochemical changes in pigmentation in all 5 subjects
Histology assess parameter including pigmentation
Measured: Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5)
Immunohistochemical changes in inflammation in all 5 subjects
Histology assess parameter including inflammation
Measured: Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start15 Nov 2023
- Primary completion1 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasneem Mohammad, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149780
- Sponsor's protocol ID
- 16268
- Status last verified
- Mar 2025
- First submitted
- 24 Oct 2023
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Fractionated 1927-nm Non Ablative Thulium Laser in Treating Post Inflammatory Hyperpigmentation in Skin Phototypes IV-VI
- ClinicalTrials.gov ID
- NCT06149780
- Acronym / sponsor ID
- 16268
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 29 Nov 2023 (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.
To study the effect of fractionated 1927-nm non ablative thulium laser in reduction of post inflammatory hyperpigmentation (PIH) using a validated and reproducible model for studying PIH.
- Determine if there is aa reduction in PIH in patients treated with three (3) monthly sessions of fractionated 1927-nm non ablative thulium laser
- Determine if there is efficacy of post-procedure clobetasol propionate 0.05% ointment in the management of PIH
- Determine the histological and molecular changes that occur with laser and laser plus topical steroid treatment compared to untreated skin
Detailed description
The design of the study consists of a total of six visits including one initial screening visit within 107-127 days depending on the scheduling of your screening and subsequent visits. Assessments such as visual examination, photography, Investigatory Global Assessment (IGA) of pigmentation and erythema; Colorimetry; and Diffuse Reflectance Spectroscopy of the intended treatment area will be conducted at Visits 1-5. Optional biopsies will be taken at various time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fractional laser patients treated with laser | Experimental | Device: Patients treated with laserLaser with topical steroid and laser with vehicle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient age 18 and older
- Patient with skin phototypes IV-VI
- Patient able to understand requirements of the study and risks involved
- Patient able to sign a consent form
- Patient to have discontinued all oral medications used to treat pigmentary abnormalities and all topical medications, except for sunscreen, used to treat pigmentary abnormalities on the buttocks one month prior to treatment
Key exclusion criteria (2 listed)
- A patient who has skin dyspigmentation, birth marks, tattoos, or other skin findings at baseline on either buttock that may obscure study results
- A patient who is lactating, pregnant, or planning to become pregnant
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 |
|---|---|---|
| Patients treated with laserPatients treated with laser with topical steroid Patients treated with laser with vehicle | Device | Fractional laser patients treated with laser |
Primary outcome
Degree of Pigmentation in all 5 subjects
Time frame: Visit 1 (Day 0) through Visit 5 (Day 112 ±5)
Measured clinical with IGA objectively with colometry
2 secondary outcomes
Immunohistochemical changes in pigmentation in all 5 subjects
Time frame: Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5)
Immunohistochemical changes in inflammation in all 5 subjects
Time frame: Visit 2 (Day 28±5) and Visit 5 (Day 112 ±5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients treated with laser in people with Healthy, run by Henry Ford Health System 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 25 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fanar Razoky, Bachelors (313-694-1923, frazoky1@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Pigmentation in all 5 subjects (time frame: Visit 1 (Day 0) through Visit 5 (Day 112 ±5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2025.