Postinflammatory HyperpigmentationPhase 2/3NCT03361345
Topical 5% Tranexamic Acid as a Treatment for Postinflammatory Hyperpigmentation Due to Acne Vulgaris
A Phase 2/3 study testing Tranexamic Acid in people with Postinflammatory Hyperpigmentation, run by Wayne State University at 1 site in United States.
Trial summary
The goal of this study is to determine if topical tranexamic acid is capable of decreasing the pigment of the dark spots left from acne bumps. The first line medication used for this often is not tolerated well by patients, and topical tranexamic acid has minimal reported side effects thus far. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postinflammatory Hyperpigmentation
- What is being tested?
- Tranexamic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 9 Jan 2022
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 65
- Patients with bilateral involvement of facial postinflammatory hyperpigmentation due to acne vulgaris.
Who cannot join
- Pregnant patients or patients planning to become pregnant during the time of the study.
- Patients with a history of use of hydroquinone, kojic acid, tretinoin, adapalene, tazarotene or azaleic acid in the previous 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to determine if topical tranexamic acid is capable of decreasing the pigment of the dark spots left from acne bumps. The first line medication used for this often is not tolerated well by patients, and topical tranexamic acid has minimal reported side effects thus far.
- Conditions
- Postinflammatory Hyperpigmentation
- Being tested
- Tranexamic Acid, Vehicle
- Keywords
- Postinflammatory hyperpigmentation, Acne
- Medical subject headings
- Hyperpigmentation, Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Topical tranexamic acid in cream form applied to dark spots on right side of face.
VehicleDrug
The Vehicle is going to be a cream without any active medication that will be applied as a control substance for the topical tranexamic acid cream, and will be applied to the contralateral side of the face.
| Study group | Role | What they receive |
|---|---|---|
| Right Side of Face | Experimental | Patients will apply topical tranexamic acid to the dark spots on the one side of their face. Receives: Drug: Tranexamic Acid |
| Left Side of Face | Sham comparator | Patients will apply the vehicle cream without any medication to the dark spots on one side of their face. Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Pigmentation at 4 Weeks.
Patients will have their lesion pigmentation scored with the postacne hyperpigmentation index after 4 weeks.
The postacne hyperpigmentation index (PAHPI) assesses hyperpigmentation lesions after acne based on the median lesion size, the median lesion intensity, and the number of lesions present. The total score can range from 6-22 points. Subscales will measure lesion size, lesion intensity, and number of lesions. Subscales will be assigned a number based on the table in the protocol, and then added together to form the total score. Higher values indicate worse hyperpigmentation. We will measure the total decrease in the PAHPI at the follow-up visit.
Measured: 4 Weeks.
Change from Baseline Pigmentation at 8 Weeks.
Patients will have their lesion pigmentation scored with the postacne hyperpigmentation index after 8 weeks.
The postacne hyperpigmentation index (PAHPI) assesses hyperpigmentation lesions after acne based on the median lesion size, the median lesion intensity, and the number of lesions present. The total score can range from 6-22 points. Subscales will measure lesion size, lesion intensity, and number of lesions. Subscales will be assigned a number based on the table in the protocol, and then added together to form the total score. Higher values indicate worse hyperpigmentation. We will measure the total decrease in the PAHPI at the follow-up visit.
Measured: 8 Weeks
Change from Baseline Pigmentation at 12 Weeks.
Patients will have their lesion pigmentation scored with the postacne hyperpigmentation index after 12 weeks.
The postacne hyperpigmentation index (PAHPI) assesses hyperpigmentation lesions after acne based on the median lesion size, the median lesion intensity, and the number of lesions present. The total score can range from 6-22 points. Subscales will measure lesion size, lesion intensity, and number of lesions. Subscales will be assigned a number based on the table in the protocol, and then added together to form the total score. Higher values indicate worse hyperpigmentation. We will measure the total decrease in the PAHPI at the follow-up visit.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start1 Nov 2018
- Primary completion9 Jan 2022
- Study completion9 Jan 2022
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-face study in which topical tranexamic acid will be applied to one side of the face and the other side of the face will be the placebo/vehicle as a control.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven D Daveluy, Wayne State University
- Investigators
- Steven Daveluy, Principal investigator, WSUPG Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361345
- Sponsor's protocol ID
- 1709000866
- Status last verified
- May 2023
- First submitted
- 17 Nov 2017
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Davis 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 20725554Darji K, Varade R, West D, Armbrecht ES, Guo MA. Psychosocial Impact of Postinflammatory Hyperpigmentation in Patients with Acne Vulgaris. J Clin Aesthet Dermatol. 2017 May;10(5):18-23. Epub 2017 May 1.
PubMed 28670354Atefi N, Dalvand B, Ghassemi M, Mehran G, Heydarian A. Therapeutic Effects of Topical Tranexamic Acid in Comparison with Hydroquinone in Treatment of Women with Melasma. Dermatol Ther (Heidelb). 2017 Sep;7(3):417-424. doi: 10.1007/s13555-017-0195-0. Epub 2017 Jul 26.
PubMed 28748406Kim SJ, Park JY, Shibata T, Fujiwara R, Kang HY. Efficacy and possible mechanisms of topical tranexamic acid in melasma. Clin Exp Dermatol. 2016 Jul;41(5):480-5. doi: 10.1111/ced.12835. Epub 2016 May 2.
PubMed 27135282Na JI, Choi SY, Yang SH, Choi HR, Kang HY, Park KC. Effect of tranexamic acid on melasma: a clinical trial with histological evaluation. J Eur Acad Dermatol Venereol. 2013 Aug;27(8):1035-9. doi: 10.1111/j.1468-3083.2012.04464.x. Epub 2012 Feb 13.
PubMed 22329442Ebrahimi B, Naeini FF. Topical tranexamic acid as a promising treatment for melasma. J Res Med Sci. 2014 Aug;19(8):753-7.
PubMed 25422661Savory SA, Agim NG, Mao R, Peter S, Wang C, Maldonado G, Bearden Dietert J, Lieu TJ, Wang C, Pretzlaff K, Das S, Vandergriff T, Lopez IE, Litzner BR, Hynan LS, Arellano-Mendoza MI, Bergstresser PR, Pandya AG. Reliability assessment and validation of the postacne hyperpigmentation index (PAHPI), a new instrument to measure postinflammatory hyperpigmentation from acne vulgaris. J Am Acad Dermatol. 2014 Jan;70(1):108-14. doi: 10.1016/j.jaad.2013.09.017. Epub 2013 Oct 28.
PubMed 24176524
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical 5% Tranexamic Acid as a Treatment for Postinflammatory Hyperpigmentation Due to Acne Vulgaris
- ClinicalTrials.gov ID
- NCT03361345
- Acronym / sponsor ID
- 1709000866
- Conditions
- Postinflammatory Hyperpigmentation
- Keywords
- Postinflammatory hyperpigmentation, Acne
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 9 Jan 2022 (actual)
- Study completion
- 9 Jan 2022 (actual)
- First posted
- 4 Dec 2017 (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.
The goal of this study is to determine if topical tranexamic acid is capable of decreasing the pigment of the dark spots left from acne bumps. The first line medication used for this often is not tolerated well by patients, and topical tranexamic acid has minimal reported side effects thus far.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Split-face study in which topical tranexamic acid will be applied to one side of the face and the other side of the face will be the placebo/vehicle as a control.
| Arm | Type | Receives |
|---|---|---|
| Right Side of Face | Experimental | Drug: Tranexamic AcidPatients will apply topical tranexamic acid to the dark spots on the one side of their face. |
| Left Side of Face | Sham comparator | Drug: VehiclePatients will apply the vehicle cream without any medication to the dark spots on one side of their face. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 to 65
- Patients with bilateral involvement of facial postinflammatory hyperpigmentation due to acne vulgaris.
Key exclusion criteria (2 listed)
- Pregnant patients or patients planning to become pregnant during the time of the study.
- Patients with a history of use of hydroquinone, kojic acid, tretinoin, adapalene, tazarotene or azaleic acid in the previous 3 months.
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 |
|---|---|---|
| Tranexamic AcidTopical tranexamic acid in cream form applied to dark spots on right side of face. | Drug | Right Side of Face |
| VehicleThe Vehicle is going to be a cream without any active medication that will be applied as a control substance for the topical tranexamic acid cream, and will be applied to the contralateral side of the face. | Drug | Left Side of Face |
Primary outcome
Change from Baseline Pigmentation at 4 Weeks.
Time frame: 4 Weeks.
Patients will have their lesion pigmentation scored with the postacne hyperpigmentation index after 4 weeks. The postacne hyperpigmentation index (PAHPI) assesses hyperpigmentation lesions after acne based on the median lesion size, the median lesion intensity, and the number of lesions present. The total score can range from 6-22 points. Subscales will measure lesion size, lesion intensity, and number of lesions. Subscales will be assigned a number based on the table in the protocol, and then added together to form the total score. Higher values indicate worse hyperpigmentation. We will measure the total decrease in the PAHPI at the follow-up visit.
Change from Baseline Pigmentation at 8 Weeks.
Time frame: 8 Weeks
Patients will have their lesion pigmentation scored with the postacne hyperpigmentation index after 8 weeks. The postacne hyperpigmentation index (PAHPI) assesses hyperpigmentation lesions after acne based on the median lesion size, the median lesion intensity, and the number of lesions present. The total score can range from 6-22 points. Subscales will measure lesion size, lesion intensity, and number of lesions. Subscales will be assigned a number based on the table in the protocol, and then added together to form the total score. Higher values indicate worse hyperpigmentation. We will measure the total decrease in the PAHPI at the follow-up visit.
Change from Baseline Pigmentation at 12 Weeks.
Time frame: 12 Weeks
Patients will have their lesion pigmentation scored with the postacne hyperpigmentation index after 12 weeks. The postacne hyperpigmentation index (PAHPI) assesses hyperpigmentation lesions after acne based on the median lesion size, the median lesion intensity, and the number of lesions present. The total score can range from 6-22 points. Subscales will measure lesion size, lesion intensity, and number of lesions. Subscales will be assigned a number based on the table in the protocol, and then added together to form the total score. Higher values indicate worse hyperpigmentation. We will measure the total decrease in the PAHPI at the follow-up visit.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- 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 28670354Darji K, Varade R, West D, Armbrecht ES, Guo MA. Psychosocial Impact of Postinflammatory Hyperpigmentation in Patients with Acne Vulgaris. J Clin Aesthet Dermatol. 2017 May;10(5):18-23. Epub 2017 May 1.
- Background: PubMed 28748406Atefi N, Dalvand B, Ghassemi M, Mehran G, Heydarian A. Therapeutic Effects of Topical Tranexamic Acid in Comparison with Hydroquinone in Treatment of Women with Melasma. Dermatol Ther (Heidelb). 2017 Sep;7(3):417-424. doi: 10.1007/s13555-017-0195-0. Epub 2017 Jul 26.
- Background: PubMed 27135282Kim SJ, Park JY, Shibata T, Fujiwara R, Kang HY. Efficacy and possible mechanisms of topical tranexamic acid in melasma. Clin Exp Dermatol. 2016 Jul;41(5):480-5. doi: 10.1111/ced.12835. Epub 2016 May 2.
- Background: PubMed 22329442Na JI, Choi SY, Yang SH, Choi HR, Kang HY, Park KC. Effect of tranexamic acid on melasma: a clinical trial with histological evaluation. J Eur Acad Dermatol Venereol. 2013 Aug;27(8):1035-9. doi: 10.1111/j.1468-3083.2012.04464.x. Epub 2012 Feb 13.
- Background: PubMed 25422661Ebrahimi B, Naeini FF. Topical tranexamic acid as a promising treatment for melasma. J Res Med Sci. 2014 Aug;19(8):753-7.
- Background: PubMed 24176524Savory SA, Agim NG, Mao R, Peter S, Wang C, Maldonado G, Bearden Dietert J, Lieu TJ, Wang C, Pretzlaff K, Das S, Vandergriff T, Lopez IE, Litzner BR, Hynan LS, Arellano-Mendoza MI, Bergstresser PR, Pandya AG. Reliability assessment and validation of the postacne hyperpigmentation index (PAHPI), a new instrument to measure postinflammatory hyperpigmentation from acne vulgaris. J Am Acad Dermatol. 2014 Jan;70(1):108-14. doi: 10.1016/j.jaad.2013.09.017. Epub 2013 Oct 28.
- 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.
Steven Daveluy principal investigator
WSUPG Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tranexamic Acid in people with Postinflammatory Hyperpigmentation, run by Wayne State University 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 2 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: withdrawn, as of the sponsor's last update on 16 May 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change from Baseline Pigmentation at 4 Weeks. (time frame: 4 Weeks.). 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 NCT03361345, which also lists 7 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 16 May 2023.