Optimizing Phototesting and Investigating Photobiology of Visible Light
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Pigmentation assessment for all 14 participants.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
VL+UVA1
Participants will be treated with VL + UVA1 light source
干预措施: Light Source B: Visible Light solar simulator (VL + UVA1) (Device)
VL+UVA1
Participants will be treated with VL + UVA1 light source
干预措施: Light Source A: Visible Light solar simulator closer match to sunlight (VL +UVA1) (Device)
结局指标
主要结局
Pigmentation assessment for all 14 participants.
时间窗: 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)
Erythema assessment for all 14 participants.
时间窗: 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
时间窗: 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
时间窗: 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)
Pigmentation assessment for all 14
时间窗: 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)
Erythema assessment for all 14 participants
时间窗: 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
Erythema assessment for 14 participants
时间窗: 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)
Pigmentation assessment for all 14 participants..
时间窗: 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
时间窗: 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 14 participants
时间窗: 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)
Erythema assessment for all 14 participants
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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 all 14 participants
时间窗: 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
时间窗: 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
次要结局
- RNA sequencing for 8 participants(Visit 2 (Day 1))
- Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants(Visit 3 (Day 7))
- Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants(Visit 1 (Day 0))
- Immunohistochemical changes in pigmentation, inflammation, and profileration, for all 14 participants(Visit 2 (Day 1))
研究者
Indermeet Kohli
Associate Scientist
Henry Ford Health System