Post-inflammatory HyperpigmentationNCT02905903
An In Vivo Model for Postinflammatory Hyperpigmentation
A study testing Tricholoacetic Acid (TCA) in people with Post-inflammatory Hyperpigmentation, run by Henry Ford Health System at 1 site in United States.
Trial summary
Post-inflammatory hyperpigmentation (PIH) is an acquired hypermelanosis that occurs after cutaneous inflammation or injury that frequently affects darker skinned populations. Previously, a model of 35% TCA-induced PIH was validated against acne induced PIH, which has value in product testing for the treatment of PIH. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-inflammatory Hyperpigmentation
- What is being tested?
- Tricholoacetic Acid (TCA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2016to 21 Jun 2019
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with types I-VI skin
- Minimum age of 18 years
- Able to understand requirements of the study and risks involved
- Able to sign a consent form.
- Existing truncal acne pustules (at least two on the trunk) with or without history of post-inflammatory hyperpigmentation
Who cannot join
- Patients with a recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of PIH judged to be clinically significant by the investigator
- Patients with a history of keloids
- Patients with a history of cystic acne or acne conglobata
- Patients on systemic antibiotics or keratolytics (isotretinoin, etc), or topical antibiotics or keratolytic use (retinoids, benzoyl peroxide) over target areas who are unwilling to stop these medications for the duration of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,
Detroit, Michigan, 48202
About this study
Official title: An In Vivo Model for Postinflammatory Hyperpigmentation: Part II
Post-inflammatory hyperpigmentation (PIH) is an acquired hypermelanosis that occurs after cutaneous inflammation or injury that frequently affects darker skinned populations. Previously, a model of 35% TCA-induced PIH was validated against acne induced PIH, which has value in product testing for the treatment of PIH. In this second phase of the study, the investigators would like to determine if a lower concentration of TCA-induced PIH is comparable to acne-induced PIH.
Read the detailed description
Post-inflammatory hyperpigmentation (PIH) is an acquired hypermelanosis that occurs after cutaneous inflammation or injury. This process can occur in all skin types but more frequently affects darker skinned patients, such as African-Americans, Hispanics, Asians, Native Americans, Pacific Islanders and those of Middle Eastern descent. PIH can occur after infection, allergic reactions, contact dermatitis, some medications, burns, following procedures, or inflammatory disease such as acne. In skin of color, PIH frequently occurs in resolving acne lesions and can persist for months after the acne lesion itself has disappeared. In many cases, the resulting PIH can be more distressing than the original insult.
During the first phase of this study, the investigators investigated the clinical, spectroscopic and histologic characteristics of acne-induced PIH versus irritant induced PIH using Trichloroacetic acid (TCA), 35% solution. From this initial study, the investigators concluded that the similarity of Investigator's Global Assessment scores, and spectroscopic measurements using Diffuse Reflectance Spectroscopy and Colorimetry in both acne and TCA-induced PIH at Day 28 suggest that TCA-induced PIH could be a reproducible model for acne induced PIH.
MicroRNAs (miRNAs) are a class of small non-coding RNA molecules that regulate the expression of multiple genes at the post-transcriptional level through degradation and translation of target mRNAs. In the initial study, the investigators hypothesized that miRNAs derived from melanocytes and immune cells during PIH development could be detected in tissue and serve as novel biomarkers for PIH and making appropriate therapeutic decisions. To test this hypothesis, the investigators first examined miRNA gene expression profiles during PIH development using different models, and then evaluated miRNAs profiles in acne- induced PIH, TCA- induced PIH and normal skin. The investigators have defined some miRNAs that potentially are involved in PIH development and may be also serve as the biomarkers for PIH. The investigators found that there were 19 miRNA changes in acne-induced PIH versus normal skin, while 43 miRNA changes in TCA-inducedPIH versus normal skin. Interestingly, about 80% changed genes in acne were included in TCA-mediated miRNA changes, suggesting TCA can partially mimic acne-PIH.
Overall, this initial model for PIH, using TCA, serves as a foundation to better understand and improve our ability to manage PIH. In this next phase of the study, the investigators will refine this in vivo model for PIH by determining the optimal concentration of TCA to induce PIH.
- Conditions
- Post-inflammatory Hyperpigmentation
- Being tested
- Tricholoacetic Acid (TCA)
- Medical subject headings
- Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tricholoacetic Acid (TCA)Drug
We will be applying 4 concentrations of TCA (20%, 25%, 30%, 35%) to the buttocks to two spots each (total of 8 lesions) and following characteristics of these lesions and comparing them to acne induced PIH during the course of the study.
| Study group | Role | What they receive |
|---|---|---|
| Trichloroacetic Acid | Other | Intervention-Apply 4 concentrations of TCA (20%, 25%, 30%, 35%) to the buttocks to two spots each (total of 8 lesions) and following characteristics of these lesions and comparing them to acne induced PIH during the course of the study. Comparisons will be made using Investigators Global Assessment scoring of hyperpigmentation and erythema, colorimetry, photography, and biopsies Receives: Drug: Tricholoacetic Acid (TCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal TCA concentration for induction of post-inflammatory hyperpigmentation
This will be determined by comparing acne induced PIH and the different concentrations of TCA induced PIH
Measured: 35 days
Study genetic components of post-inflammatory hyperpigmentation by evaluating single nucleotide polymorphism and microRNA
These will be evaluated by blood draws and biopsy
Measured: 35 days
Study individual risk factors for those susceptible to developing postinflammatory hyperpigmention
These will be evaluated by surveys and comparing subjects with PIH versus no PIH
Measured: 35 days
Secondary outcomes (1)
validate a quality of life questionnaire for post-inflammatory hyperpigmentation.
Administration of PIH surveys
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start14 Feb 2016
- Primary completion16 May 2018
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post-inflammatory 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iltefat Hamzavi, Henry Ford Health System
- Investigators
- Iltefat Hamzavi, MD, Principal investigator, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905903
- Sponsor's protocol ID
- IRB #9920 Protocol 1
- Status last verified
- Feb 2022
- First submitted
- 14 Sep 2016
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Taylor S, Grimes P, Lim J, Im S, Lui H. Postinflammatory hyperpigmentation. J Cutan Med Surg. 2009 Jul-Aug;13(4):183-91. doi: 10.2310/7750.2009.08077.
PubMed 19706225Davis EC, Callender VD. Postinflammatory hyperpigmentation: a review of the epidemiology, clinical features, and treatment options in skin of color. J Clin Aesthet Dermatol. 2010 Jul;3(7):20-31.
PubMed 20725554Baumann L, Rodriguez D, Taylor SC, Wu J. Natural considerations for skin of color. Cutis. 2006 Dec;78(6 Suppl):2-19.
PubMed 17354519Grimes PE, Stockton T. Pigmentary disorders in blacks. Dermatol Clin. 1988 Apr;6(2):271-81.
PubMed 3378372Motokawa T, Kato T, Hashimoto Y, Katagiri T. Effect of Val92Met and Arg163Gln variants of the MC1R gene on freckles and solar lentigines in Japanese. Pigment Cell Res. 2007 Apr;20(2):140-3. doi: 10.1111/j.1600-0749.2007.00364.x.
PubMed 17371441Szell M, Baltas E, Bodai L, Bata-Csorgo Z, Nagy N, Dallos A, Pourfarzi R, Simics E, Kondorosi I, Szalai Z, Toth GK, Hunyadi J, Dobozy A, Kemeny L. The Arg160Trp allele of melanocortin-1 receptor gene might protect against vitiligo. Photochem Photobiol. 2008 May-Jun;84(3):565-71. doi: 10.1111/j.1751-1097.2008.00296.x. Epub 2008 Feb 11.
PubMed 18282185
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An In Vivo Model for Postinflammatory Hyperpigmentation: Part II
- ClinicalTrials.gov ID
- NCT02905903
- Acronym / sponsor ID
- IRB #9920 Protocol 1
- Conditions
- Post-inflammatory Hyperpigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 14 Feb 2016 (actual)
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 19 Sep 2016 (estimated)
- 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.
Post-inflammatory hyperpigmentation (PIH) is an acquired hypermelanosis that occurs after cutaneous inflammation or injury that frequently affects darker skinned populations. Previously, a model of 35% TCA-induced PIH was validated against acne induced PIH, which has value in product testing for the treatment of PIH. In this second phase of the study, the investigators would like to determine if a lower concentration of TCA-induced PIH is comparable to acne-induced PIH.
Detailed description
Post-inflammatory hyperpigmentation (PIH) is an acquired hypermelanosis that occurs after cutaneous inflammation or injury. This process can occur in all skin types but more frequently affects darker skinned patients, such as African-Americans, Hispanics, Asians, Native Americans, Pacific Islanders and those of Middle Eastern descent. PIH can occur after infection, allergic reactions, contact dermatitis, some medications, burns, following procedures, or inflammatory disease such as acne. In skin of color, PIH frequently occurs in resolving acne lesions and can persist for months after the acne lesion itself has disappeared. In many cases, the resulting PIH can be more distressing than the original insult.
During the first phase of this study, the investigators investigated the clinical, spectroscopic and histologic characteristics of acne-induced PIH versus irritant induced PIH using Trichloroacetic acid (TCA), 35% solution. From this initial study, the investigators concluded that the similarity of Investigator's Global Assessment scores, and spectroscopic measurements using Diffuse Reflectance Spectroscopy and Colorimetry in both acne and TCA-induced PIH at Day 28 suggest that TCA-induced PIH could be a reproducible model for acne induced PIH.
MicroRNAs (miRNAs) are a class of small non-coding RNA molecules that regulate the expression of multiple genes at the post-transcriptional level through degradation and translation of target mRNAs. In the initial study, the investigators hypothesized that miRNAs derived from melanocytes and immune cells during PIH development could be detected in tissue and serve as novel biomarkers for PIH and making appropriate therapeutic decisions. To test this hypothesis, the investigators first examined miRNA gene expression profiles during PIH development using different models, and then evaluated miRNAs profiles in acne- induced PIH, TCA- induced PIH and normal skin. The investigators have defined some miRNAs that potentially are involved in PIH development and may be also serve as the biomarkers for PIH. The investigators found that there were 19 miRNA changes in acne-induced PIH versus normal skin, while 43 miRNA changes in TCA-inducedPIH versus normal skin. Interestingly, about 80% changed genes in acne were included in TCA-mediated miRNA changes, suggesting TCA can partially mimic acne-PIH.
Overall, this initial model for PIH, using TCA, serves as a foundation to better understand and improve our ability to manage PIH. In this next phase of the study, the investigators will refine this in vivo model for PIH by determining the optimal concentration of TCA to induce PIH.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trichloroacetic Acid | Other | Drug: Tricholoacetic Acid (TCA)Intervention-Apply 4 concentrations of TCA (20%, 25%, 30%, 35%) to the buttocks to two spots each (total of 8 lesions) and following characteristics of these lesions and comparing them to acne induced PIH during the course of the study. Comparisons will be made using Investigators Global Assessment scoring of hyperpigmentation and erythema, colorimetry, photography, and biopsies |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with types I-VI skin
- Minimum age of 18 years
- Able to understand requirements of the study and risks involved
- Able to sign a consent form.
- Existing truncal acne pustules (at least two on the trunk) with or without history of post-inflammatory hyperpigmentation
Key exclusion criteria (4 listed)
- Patients with a recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of PIH judged to be clinically significant by the investigator
- Patients with a history of keloids
- Patients with a history of cystic acne or acne conglobata
- Patients on systemic antibiotics or keratolytics (isotretinoin, etc), or topical antibiotics or keratolytic use (retinoids, benzoyl peroxide) over target areas who are unwilling to stop these medications for 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 |
|---|---|---|
| Tricholoacetic Acid (TCA)We will be applying 4 concentrations of TCA (20%, 25%, 30%, 35%) to the buttocks to two spots each (total of 8 lesions) and following characteristics of these lesions and comparing them to acne induced PIH during the course of the study. | Drug | Trichloroacetic Acid |
Primary outcome
Optimal TCA concentration for induction of post-inflammatory hyperpigmentation
Time frame: 35 days
This will be determined by comparing acne induced PIH and the different concentrations of TCA induced PIH
Study genetic components of post-inflammatory hyperpigmentation by evaluating single nucleotide polymorphism and microRNA
Time frame: 35 days
These will be evaluated by blood draws and biopsy
Study individual risk factors for those susceptible to developing postinflammatory hyperpigmention
Time frame: 35 days
These will be evaluated by surveys and comparing subjects with PIH versus no PIH
1 secondary outcome
validate a quality of life questionnaire for post-inflammatory hyperpigmentation.
Time frame: 35 days
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 2 Mar 2022.
- Background: PubMed 19706225Taylor S, Grimes P, Lim J, Im S, Lui H. Postinflammatory hyperpigmentation. J Cutan Med Surg. 2009 Jul-Aug;13(4):183-91. doi: 10.2310/7750.2009.08077.
- Background: PubMed 20725554Davis EC, Callender VD. Postinflammatory hyperpigmentation: a review of the epidemiology, clinical features, and treatment options in skin of color. J Clin Aesthet Dermatol. 2010 Jul;3(7):20-31.
- Background: PubMed 17354519Baumann L, Rodriguez D, Taylor SC, Wu J. Natural considerations for skin of color. Cutis. 2006 Dec;78(6 Suppl):2-19.
- Background: PubMed 3378372Grimes PE, Stockton T. Pigmentary disorders in blacks. Dermatol Clin. 1988 Apr;6(2):271-81.
- Background: PubMed 17371441Motokawa T, Kato T, Hashimoto Y, Katagiri T. Effect of Val92Met and Arg163Gln variants of the MC1R gene on freckles and solar lentigines in Japanese. Pigment Cell Res. 2007 Apr;20(2):140-3. doi: 10.1111/j.1600-0749.2007.00364.x.
- Background: PubMed 18282185Szell M, Baltas E, Bodai L, Bata-Csorgo Z, Nagy N, Dallos A, Pourfarzi R, Simics E, Kondorosi I, Szalai Z, Toth GK, Hunyadi J, Dobozy A, Kemeny L. The Arg160Trp allele of melanocortin-1 receptor gene might protect against vitiligo. Photochem Photobiol. 2008 May-Jun;84(3):565-71. doi: 10.1111/j.1751-1097.2008.00296.x. Epub 2008 Feb 11.
- 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.
Iltefat Hamzavi, MD principal investigator
Henry Ford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tricholoacetic Acid (TCA) in people with Post-inflammatory Hyperpigmentation, 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 4 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 2 Mar 2022. 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?
Optimal TCA concentration for induction of post-inflammatory hyperpigmentation (time frame: 35 days). The study lists 3 primary outcomes in all. 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 NCT02905903, which also lists 6 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 2 Mar 2022.