An interventional study of Topical Cetyl Tranexamate Mesylate in Hyperpigmentation, Post-inflammatory Hyperpigmentation and Acne, sponsored by Integrative Skin Science and Research. Completed at 1 site in United States. Open to participants aged 14 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by Integrative Skin Science and Research · Not applicable, Interventional, and Treatment
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Among 35 studies in Hyperpigmentation with a site in United States — 2 open to participants now, 2 under way, none of them phase 3. Hyperpigmentation · United States.
Among the 35 studies in Hyperpigmentation with a site in United States, this one is the 14th largest by enrollment of the 32 interventional ones that give a count, is one of 2 that started in 2023, is one of 20 with no phase, and was the 25th registered.
128 studies on the registry are indexed under Hyperpigmentation; 28 are open to participants now.
Browse Hyperpigmentation studies →2 of the 35 studies in Hyperpigmentation with a site in United States are open now. Recruiting first, the newest first:
Montefiore Medical Center · Sites in United States
Ages 18+ · Healthy volunteers
Weill Medical College of Cornell University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 16 Hyperpigmentation studies recruiting now, 8 (50%) set no upper age limit and 8 (50%) stop at 75 or younger; 2 take children under 18; 8 take healthy volunteers.
This study: 14 Years to 45 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
35 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 4 · Phase 3 2 · Phase 4 7
First in 2007; this study’s year is marked. 2 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 22 is below the median of 32 across 114 interventional studies indexed under Hyperpigmentation.
Median enrollment 21 across the 32 interventional studies, 44 across the 3 observational. Of the 29 that completed or were terminated, 8 (28%) have results posted.
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15 of 35 have an industry lead sponsor. The 10 most frequent:
Integrative Skin Science and Research is the lead sponsor of 35 studies on the registry; 12 are open to participants now.
Integrative Skin Science and Research has 2 studies filed under Hyperpigmentation — fewer than ten, so there is no comparison to draw.
1 of the studies in Hyperpigmentation with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07896486Weill Medical College of Cornell UniversityEvaluating a Brightening Serum for Post-Inflammatory Hyperpigmentation | 2027-01-15 |
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Among the 35 studies in Hyperpigmentation with a site in United States, from their registry updates:
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The purpose of this study is to assess the effects of Cetyl Tranexamate Mesylate on acne-related hyperpigmentation through a specific delivery form known as TeraCeutic TXVector.
Hyperpigmentation is characterized as an increase in pigment on the skin and is a common skin condition in individuals with skin types III to VI on the Fitzpatrick skin classification scale. Hyperpigmentation can be localized to an area in the form of post-inflammatory hyperpigmentation or diffused in the form of melasma. One of the treatments that are used to treat hyperpigmentation is tranexamic acid (TXA) which is a third-generation bioactive and is formally known to work as a plasmin inhibitor. Since TXA is hydrophilic in nature and has a strong hydrogen-bonding capacity, it has an insufficient skin permeability. Similar to TXA esters, Cetyl Tranexamate Mesylate (CTM) is hypothesized to have greater permeability and this study will evaluate the effects of CTM on the appearance of post-inflammatory hyperpigmentation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Product will be used on the face twice daily in the morning and in the evening for 2 weeks.
Other: Topical Cetyl Tranexamate Mesylate
Topical product will be applied onto clean skin morning and night.
Facial skin pigment intensity of 3 pre-identified lesions
Change in the appearance of pigment intensity (melanin measurement) of 3 pre-identified hyperpigmented lesions
Time frame: 2 weeks
Facial skin pigment intensity of 3 pre-identified lesions
Change in the appearance of pigment intensity (melanin measurement) of 3 pre-identified hyperpigmented lesions
Time frame: 1 week
Self-perception of skin pigmentation
Survey-based self-assessment of facial skin pigmentation
Time frame: 1 week
Self-perception of skin pigmentation
Survey-based self-assessment of facial skin pigmentation
Time frame: 2 week
Self-perception of skin redness
Survey-based self-assessment of aspects of skin redness
Time frame: 1 week
Self-perception of skin redness
Survey-based self-assessment of aspects of skin redness
Time frame: 2 week
Ran from Nov 2023 to primary completion in Jan 2024, 2 months.
Of 28 industry-sponsored interventional studies with no phase under Hyperpigmentation, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 7. This study's 2 months is below that.
Counting every sponsor, half of 65 studies reached it within 7 months; a quarter within 3 and three quarters within 20.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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