Psoriasis Vulgaris study: Total coumarin vs Vehicle cream
Official title Efficacy and Safety of a Botanical Total Coumarin (TC) Cream in Treating Patients With Psoriasis Vulgaris (PLANTCOAT-III)
ClinicalTrials.gov ID: NCT07426120
What this study is testing
What is Total coumarin (TC) cream?
This is an investigational topical cream being studied as a potential treatment for psoriasis vulgaris.
Also referred to as TC Cream.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out if the cream improves psoriasis symptoms and quality of life. It also checks for any safety issues.
- Who it's for
- The study is looking for adults who have psoriasis.
- What's involved
- Participants will apply the cream or a look-alike cream to their skin twice a day. They will also keep a diary of their symptoms and visit the clinic for checkups.
- Time commitment
- The study lasts 8 weeks and requires clinic visits every two weeks.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age of 18-70 years old. Both men and women, and members of all races and ethnic groups
- Consistent with the diagnostic criteria of stable phase psoriasis vulgaris, and have at least two target lesions suitable for evaluation
- Women of childbearing age must be using birth control strategies defined by one of the following: 1) a barrier method (condom) and/or 2) oral...
- ISGA score ≥ 2 (at least mild severity)
- BSA (stable stage group): 1%≤ to ≤20%
You likely can't join if
- people in pregnancy, preparing for pregnancy, or breastfeeding
- History of hyperergic or photosensitivity
- History of complicated cardiovascular diseases, cerebrovascular diseases, severe primary diseases of the hepatic, kidney, and hematopoietic system...
- History of photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosa
- Topical treatments
- PUVA, UVB, or Grenz ray therapy.
See the full eligibility criteria
- Age of 18-70 years old. Both men and women, and members of all races and ethnic groups
- Consistent with the diagnostic criteria of stable phase psoriasis vulgaris, and have at least two target lesions suitable for evaluation
- Women of childbearing age must be using birth control strategies defined by one of the following: 1) a barrier method (condom) and/or 2) oral contraceptives, during the 8-week study period.
- ISGA score ≥ 2 (at least mild severity)
- BSA (stable stage group): 1%≤ to ≤20%
- Signed a written informed consent document
- No additional exposure to the sun
- people in pregnancy, preparing for pregnancy, or breastfeeding
- History of hyperergic or photosensitivity
- History of complicated cardiovascular diseases, cerebrovascular diseases, severe primary diseases of the hepatic, kidney, and hematopoietic system, or patients with psychiatric disorders
- History of photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosa
- Topical treatments
- PUVA, UVB, or Grenz ray therapy.
- Any systemic treatments other than biologicals with a possible effect on psoriasis (e.g., corticosteroids, vitamin D analogues, hydroxycarbamide, azathioprine, methotrexate, cyclosporine, other immunosuppressants).
- Any types of other investigational therapies for psoriasis
- Within 3 months prior to randomizations, patients have taken systemic treatments with retinoids or biological therapies (marketed or otherwise) with a possible effect on psoriasis (e.g., alefacept, efalizumab...
- Planned initiation of, or changes to, concomitant medications that could affect psoriasis (e.g., beta blockers, anti-malaria drugs, lithium) during the blinded phase of the study.
- History of allergic reactions attributed to compounds of similar chemical or biologic compositions to Coumarins.
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.