HealthyNCT05964907
Optimizing Phototesting and Investigating Photobiology of Visible Light
A study testing Light Source B: Visible Light solar simulator (VL + UVA1) and Light Source A: Visible Light solar simulator closer match to sunlight (VL +UVA1) in people with Healthy, run by Henry Ford Health System at 1 site in United States.
Trial summary
Specific Aim 1: To determine the impact of spectral composition of the VL+UVA1 source on the associated biologic effects. Specific Aim 2: To investigate differential responses of subjects with different skin phototypes to VL+UVA1, including immediate and delayed erythema and pigmentation, and photodamage. 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?
- Light Source B: Visible Light solar simulator (VL + UVA1) and Light Source A: Visible Light solar simulator closer match to sunlight (VL +UVA1)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2021to 30 Dec 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
- Healthy individuals age 18 and older
- Fitzpatrick skin phototype (SPT) I-VI, 7 with SPT I-III and 7 with SPT IV-VI, with normal healthy skin
- Able to understand the requirements of the study and its associated risks
- Able to complete and sign a consent form
- Willing and able to refrain from any medications or herbal supplements during the duration of the study, unless permitted by the investigator
- Agrees to refrain from using any new topical skin care products, laundry detergents, or fragrances while participating in the study
- Has not had excessive sun exposure for 7 days prior to enrollment in the study
Who cannot join
- Recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post-inflammatory hyperpigmentation
- History of relevant skin conditions such as atopic dermatitis, eczema, or sunburn on any part of the body
- History of photodermatoses or photosensitivity disorders
- History of melanoma or non-melanoma skin cancers
- Use of tanning parlors or exposure of the irradiated sites to sun light during the duration of the study
- Use of topical or systemic treatment that is likely to interfere with assessment, study results, or pose safety concerns
Show all 11Show fewer
- Subjects with a tendency to bleed excessively
- Known allergies to anesthetics (lidocaine) or anaphylaxis treatment (epinephrine)
- History of hypertrophic scarring or keloid formation
- Use of any photosensitizing medication within the visible light range or additional medication at the discretion of the investigator [examples include - but not limited to - thiazide diuretics, regular use of NSAIDs, hydroxychloroquine, or voriconazole
- A woman who is lactating, pregnant, or planning to become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Specific Aim 1: To determine the impact of spectral composition of the VL+UVA1 source on the associated biologic effects.
Specific Aim 2: To investigate differential responses of subjects with different skin phototypes to VL+UVA1, including immediate and delayed erythema and pigmentation, and photodamage.
Read the detailed description
The design of the study consists of a total of 4 visits within a two week period. The first visit consists of VL+UVA1 irradiation with different light source on the opposite site of patients' back. A combination of non-invasive measurements (e.g., photography, redness and color changes of the skin using colorimetry and diffuse reflectance spectrometry) will be conducted throughout the 4 visits. Biopsies will be taken at various time points.
- Conditions
- Healthy
- Being tested
- Light Source B: Visible Light solar simulator (VL + UVA1), Light Source A: Visible Light solar simulator closer match to sunlight (VL +UVA1)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light Source B: Visible Light solar simulator (VL + UVA1)Device
Patients will be radiated with light source B (Visible light solar simulator)
Light Source A: Visible Light solar simulator closer match to sunlight (VL +UVA1)Device
Patients will be radiated with light source A (Visible light solar simulator closer match to sunlight)
| Study group | Role | What they receive |
|---|---|---|
| VL+UVA1 | Other | Participants will be treated with VL + UVA1 light source Receives: Device: Light Source B: Visible Light solar simulator (VL + UVA1); Device: Light Source A: Visible Light solar simulator closer match to sunlight (VL +UVA1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythema assessment for all 14 participants.
Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Erythema (Redness) 0 Clear of erythema
- Almost clear of erythema
- Mild, but noticeable erythema
- Moderate erythema (pink), no sharp borders
- Severe erythema (dark pink), sharp borders
- Very severe erythema (very dark pink to almost red)
Measured: Visit 1 (Day 0)
Erythema assessment for all participants
Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Erythema (Redness) 0 Clear of erythema
- Almost clear of erythema
- Mild, but noticeable erythema
- Moderate erythema (pink), no sharp borders
- Severe erythema (dark pink), sharp borders
- Very severe erythema (very dark pink to almost red)
Measured: Visit 2 (Day 1)
Erythema assessment
Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Erythema (Redness) 0 Clear of erythema
- Almost clear of erythema
- Mild, but noticeable erythema
- Moderate erythema (pink), no sharp borders
- Severe erythema (dark pink), sharp borders
- Very severe erythema (very dark pink to almost red)
Measured: Visit 3 (Day 7)
Erythema assessment for 14 participants
Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Erythema (Redness) 0 Clear of erythema
- Almost clear of erythema
- Mild, but noticeable erythema
- Moderate erythema (pink), no sharp borders
- Severe erythema (dark pink), sharp borders
- Very severe erythema (very dark pink to almost red)
Measured: Visit 4 (Day 14)
Erythema assessment for all 14 participants
Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)].
Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Measured: Visit 1 (Day 0)
Erythema assessment for all 14 participants
Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)].
Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Measured: Visit 2 (Day 1)
Erythema assessment for all 14 participants
Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)].
Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Measured: Visit 3 (Day 7)
Erythema assessment for all 14 participants
Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)].
Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Measured: Visit 4 (Day 14)
Pigmentation assessment for all 14 participants.
Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Pigmentation (Tanning) 0 Clear of hyperpigmentation
- Almost clear of hyperpigmentation
- Mild, but noticeable hyperpigmentation
- Moderate hyperpigmentation (medium brown)
- Severe hyperpigmentation (dark brown)
- Very severe hyperpigmentation (very dark brown to almost black)
Measured: Visit 1 (day 0)
Pigmentation assessment for all 14
Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Pigmentation (Tanning) 0 Clear of hyperpigmentation
- Almost clear of hyperpigmentation
- Mild, but noticeable hyperpigmentation
- Moderate hyperpigmentation (medium brown)
- Severe hyperpigmentation (dark brown)
- Very severe hyperpigmentation (very dark brown to almost black)
Measured: Visit 2 (Day 1)
Pigmentation assessment for 14 participants
Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Pigmentation (Tanning) 0 Clear of hyperpigmentation
- Almost clear of hyperpigmentation
- Mild, but noticeable hyperpigmentation
- Moderate hyperpigmentation (medium brown)
- Severe hyperpigmentation (dark brown)
- Very severe hyperpigmentation (very dark brown to almost black)
Measured: Visit 3 (Day 7)
Pigmentation assessment for all 14
Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Pigmentation (Tanning) 0 Clear of hyperpigmentation
- Almost clear of hyperpigmentation
- Mild, but noticeable hyperpigmentation
- Moderate hyperpigmentation (medium brown)
- Severe hyperpigmentation (dark brown)
- Very severe hyperpigmentation (very dark brown to almost black)
Measured: Visit 4 (Day 14)
Pigmentation assessment for all 14 participants..
Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)].
Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Measured: Visit 1 (day 0)
Pigmentation assessment for all 14 participants
Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)].
Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Measured: Visit 2 (Day 1)
Pigmentation assessment for all 14 participants
Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)].
Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Measured: Visit 3 (Day 7)
Pigmentation assessment for all 14 participants
Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)].
Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Measured: Visit 4 (Day 14)
Secondary outcomes (4)
Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants
Histology assess parameter including pigmentation, inflammation and proliferation.
Measured: Visit 1 (Day 0)
Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants
Histology assess parameter including pigmentation, inflammation and proliferation.
Measured: Visit 2 (Day 1)
Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants
Histology assess parameter including pigmentation, inflammation and proliferation.
Measured: Visit 3 (Day 7)
RNA sequencing for 8 participants
Molecular changes- sample collection for RNA sequencing
Measured: Visit 2 (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start6 Oct 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Indermeet Kohli, Henry Ford Health System
- Investigators
- Indermeet Kohli, PhD, Principal investigator, Henry Ford Health Dermatology Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964907
- Sponsor's protocol ID
- 14869
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2023
- Last updated
- 1 May 2026
- 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 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Phototesting and Investigating Photobiology of Visible Light
- ClinicalTrials.gov ID
- NCT05964907
- Acronym / sponsor ID
- 14869
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 28 Jul 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.
Specific Aim 1: To determine the impact of spectral composition of the VL+UVA1 source on the associated biologic effects.
Specific Aim 2: To investigate differential responses of subjects with different skin phototypes to VL+UVA1, including immediate and delayed erythema and pigmentation, and photodamage.
Detailed description
The design of the study consists of a total of 4 visits within a two week period. The first visit consists of VL+UVA1 irradiation with different light source on the opposite site of patients' back. A combination of non-invasive measurements (e.g., photography, redness and color changes of the skin using colorimetry and diffuse reflectance spectrometry) will be conducted throughout the 4 visits. Biopsies will be taken at various time points.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VL+UVA1 | Other | Device: Light Source B: Visible Light solar simulator (VL + UVA1), Device: Light Source A: Visible Light solar simulator closer match to sunlight (VL +UVA1)Participants will be treated with VL + UVA1 light source |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy individuals age 18 and older
- Fitzpatrick skin phototype (SPT) I-VI, 7 with SPT I-III and 7 with SPT IV-VI, with normal healthy skin
- Able to understand the requirements of the study and its associated risks
- Able to complete and sign a consent form
- Willing and able to refrain from any medications or herbal supplements during the duration of the study, unless permitted by the investigator
Key exclusion criteria (11 listed)
- Recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post-inflammatory hyperpigmentation
- History of relevant skin conditions such as atopic dermatitis, eczema, or sunburn on any part of the body
- History of photodermatoses or photosensitivity disorders
- History of melanoma or non-melanoma skin cancers
- Use of tanning parlors or exposure of the irradiated sites to sun light during the duration of the study
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 |
|---|---|---|
| Light Source B: Visible Light solar simulator (VL + UVA1)Patients will be radiated with light source B (Visible light solar simulator) | Device | VL+UVA1 |
| Light Source A: Visible Light solar simulator closer match to sunlight (VL +UVA1)Patients will be radiated with light source A (Visible light solar simulator closer match to sunlight) | Device | VL+UVA1 |
Primary outcome
Erythema assessment for all 14 participants.
Time frame: Visit 1 (Day 0)
Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Erythema (Redness) 0 Clear of erythema 1. Almost clear of erythema 2. Mild, but noticeable erythema 3. Moderate erythema (pink), no sharp borders 4. Severe erythema (dark pink), sharp borders 5. Very severe erythema (very dark pink to almost red)
Erythema assessment for all participants
Time frame: Visit 2 (Day 1)
Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Erythema (Redness) 0 Clear of erythema 1. Almost clear of erythema 2. Mild, but noticeable erythema 3. Moderate erythema (pink), no sharp borders 4. Severe erythema (dark pink), sharp borders 5. Very severe erythema (very dark pink to almost red)
Erythema assessment
Time frame: Visit 3 (Day 7)
Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Erythema (Redness) 0 Clear of erythema 1. Almost clear of erythema 2. Mild, but noticeable erythema 3. Moderate erythema (pink), no sharp borders 4. Severe erythema (dark pink), sharp borders 5. Very severe erythema (very dark pink to almost red)
Erythema assessment for 14 participants
Time frame: Visit 4 (Day 14)
Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Erythema (Redness) 0 Clear of erythema 1. Almost clear of erythema 2. Mild, but noticeable erythema 3. Moderate erythema (pink), no sharp borders 4. Severe erythema (dark pink), sharp borders 5. Very severe erythema (very dark pink to almost red)
Erythema assessment for all 14 participants
Time frame: Visit 1 (Day 0)
Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)]. Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Erythema assessment for all 14 participants
Time frame: Visit 2 (Day 1)
Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)]. Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Erythema assessment for all 14 participants
Time frame: Visit 3 (Day 7)
Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)]. Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Erythema assessment for all 14 participants
Time frame: Visit 4 (Day 14)
Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)]. Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Pigmentation assessment for all 14 participants.
Time frame: Visit 1 (day 0)
Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Pigmentation (Tanning) 0 Clear of hyperpigmentation 1. Almost clear of hyperpigmentation 2. Mild, but noticeable hyperpigmentation 3. Moderate hyperpigmentation (medium brown) 4. Severe hyperpigmentation (dark brown) 5. Very severe hyperpigmentation (very dark brown to almost black)
Pigmentation assessment for all 14
Time frame: Visit 2 (Day 1)
Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Pigmentation (Tanning) 0 Clear of hyperpigmentation 1. Almost clear of hyperpigmentation 2. Mild, but noticeable hyperpigmentation 3. Moderate hyperpigmentation (medium brown) 4. Severe hyperpigmentation (dark brown) 5. Very severe hyperpigmentation (very dark brown to almost black)
Pigmentation assessment for 14 participants
Time frame: Visit 3 (Day 7)
Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Pigmentation (Tanning) 0 Clear of hyperpigmentation 1. Almost clear of hyperpigmentation 2. Mild, but noticeable hyperpigmentation 3. Moderate hyperpigmentation (medium brown) 4. Severe hyperpigmentation (dark brown) 5. Very severe hyperpigmentation (very dark brown to almost black)
Pigmentation assessment for all 14
Time frame: Visit 4 (Day 14)
Measured clinically with Investigator Global Assessment (IGA) scale IGA Description of Pigmentation (Tanning) 0 Clear of hyperpigmentation 1. Almost clear of hyperpigmentation 2. Mild, but noticeable hyperpigmentation 3. Moderate hyperpigmentation (medium brown) 4. Severe hyperpigmentation (dark brown) 5. Very severe hyperpigmentation (very dark brown to almost black)
Pigmentation assessment for all 14 participants..
Time frame: Visit 1 (day 0)
Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)]. Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Pigmentation assessment for all 14 participants
Time frame: Visit 2 (Day 1)
Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)]. Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Pigmentation assessment for all 14 participants
Time frame: Visit 3 (Day 7)
Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)]. Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
Pigmentation assessment for all 14 participants
Time frame: Visit 4 (Day 14)
Both colorimetry and DRS non-invasively provide quantitative objective information regarding changes in skin color by quantifying skin hyperpigmentation and erythema as L* and a* by colorimeter, and as melanin, oxy-hemoglobin concentration by DRS respectively. ITA can be derived from L* and b* by using ITA = [arctan (L* - 50)/b*] X 180/Π)]. Colorimetry: Decrease in L* and ITA indicates greater pigmentation. Increase in a* indicates increase in Erythema. All these parameters are relative with arbitrary units DRS: Increase in Melanin content will indicate increase in pigmentation and increase in oxy-hemoglobin will indicate increase in erythema. All these parameters are relative with arbitrary units
4 secondary outcomes
Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants
Time frame: Visit 1 (Day 0)
Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants
Time frame: Visit 2 (Day 1)
Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants
Time frame: Visit 3 (Day 7)
RNA sequencing for 8 participants
Time frame: Visit 2 (Day 1)
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 1 May 2026.
- 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. This study is not recruiting at the moment.
Indermeet Kohli, PhD principal investigator
Henry Ford Health Dermatology Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light Source B: Visible Light solar simulator (VL + UVA1) and Light Source A: Visible Light solar simulator closer match to sunlight (VL +UVA1) 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 7 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. 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?
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?
Erythema assessment for all 14 participants. (time frame: Visit 1 (Day 0)). The study lists 16 primary outcomes in all. 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 1 May 2026.