Psoriasis VulgarisNCT06011083
Topical Calcipotriol /Betamethasone Ointment in the Treatment of Plaque Psoriasis
A study testing Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm and Fractional carbon dioxide (CO2) laser in people with Psoriasis Vulgaris and Fractional CO2 Laser, run by Assiut University at 1 site in Egypt.
Trial summary
comparing the clinical efficacy of topical ointment containing calcipotriol and betamethasone dipropionate used alone with the simultaneous use of fractional carbon dioxide laser and the same topical ointment containing these two ingredients as treatment modalities for plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psoriasis Vulgaris, Fractional CO2 Laser
- What is being tested?
- Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm and Fractional carbon dioxide (CO2) laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 Aug 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with chronic plaque psoriasis of either sex.
- Aged more than 18 years of age.
Who cannot join
- Pregnant and lactating women.
- Patients with severe skin infection.
- Patients who are under systemic ttt or phototherapy in the last 3 months.
- Immunosuppression or being under any kind of treatment causingabsolute or relative immunosuppression
- History of any bleeding, clotting disorder or using anticoagulants.
- Chronic systemic diseases such as chronic renal failure, hepatic insufficiency, and cardiovascular disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Calcipotriol /Betamethasone Ointment Versus Fractional CO2 Laser Plus Calcipotriol /Betamethasone Ointment in the Treatment of Plaque Psoriasis: Randomized Comparative Study
comparing the clinical efficacy of topical ointment containing calcipotriol and betamethasone dipropionate used alone with the simultaneous use of fractional carbon dioxide laser and the same topical ointment containing these two ingredients as treatment modalities for plaque psoriasis. Additionally, looking into how both therapy modalities affect individuals with psoriasis in terms of how their quality of life is improved.
Read the detailed description
Psoriasis is a widespread, persistent papulosquamous skin condition that can affect anyone at any age and places a heavy strain on both the individual and society. It is linked to a number of serious medical disorders, such as cardiometabolic syndrome, depression, and psoriatic arthritis (1).
Patients with psoriasis indicate that the condition interferes with their ability to sleep and rest, limits their everyday activities, particularly their mobility, and stigmatises them and causes problems in their social lives. Additionally, psoriasis can negatively impact mental health. Many psoriasis sufferers struggle with addiction, anxiety, and depression (2, 3).
Topical medicines continue to be the basis of treatment for those with mild psoriasis, and they include topical corticosteroids, vitamin D analogues, calcineurin inhibitors, and keratolytics (4).
For the topical management of mild psoriasis, preparations containing calcipotriol in combination with betamethasone (in the form of betamethasone dipropionate) are available (5). In comparison to the effects of these active substances when given separately, pharmacodynamic investigations demonstrated the synergy between the anti-inflammatory and immunoregulatory actions of calcipotriol and betamethasone dipropionate (6). The synergistic activity of the two drugs is what makes calcipotriol/betamethasone dipropionate combinations successful. Betamethasone impacts inflammatory processes and lessens skin irritation and pruritus following calcipotriol administration, while calcipotriol alters keratinocyte differentiation (7).
Fractional lasers were used in the treatment of dermatological diseases. They create tiny ablation channels in the skin that act as shunts for topically applied medications, particularly those with high molecular weights (8), by ablation of the skin in the form of fractions and splitting laser beams into microbeams (9).
- Conditions
- Psoriasis Vulgaris, Fractional CO2 Laser
- Being tested
- Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm, Fractional carbon dioxide (CO2) laser
- Keywords
- psoriasis vulgaris, fractional CO2 laser, Calcipotriol /Betamethasone Ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gmDrug
using topical ointment containing calcipotriol and betamethasone dipropionate for plaque psoriasis.
Fractional carbon dioxide (CO2) laserDevice
fractional CO2 laser sessions once per month for 3 months over a similar psoriatic plaque
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 20 patients who were treated with Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm twice daily as a monotherapy for 3 months over a selected psoriatic plaque Receives: Drug: Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm |
| Group B | Active comparator | 20 patients who were treated with fractional CO2 laser sessions once per month followed by application of the same Topical Ointment twice daily for 3 months over a similar psoriatic plaque Receives: Drug: Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm; Device: Fractional carbon dioxide (CO2) laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the reduction in the severity of the treated psoriatic plaques using Psoriasis severity (TES) score before treatment and after the treatment course in both groups.
Group A included 20 patients who were treated with Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm applied twice daily as a monotherapy for 3 months over a selected psoriatic plaque while Group B included 20 patients who were treated with fractional CO2 laser sessions once per month followed by application of the same topical ointment twice daily for 3 months over a similar psoriatic plaque [as regard anatomical site, size and TES (thickness, erythema, scales) score].
We used a physician-based, four-point scoring system in which the thickness, erythema, and scale within each plaque was rated from 0 (none) to 3 (severe) to evaluate the changes in the severity of individual psoriatic plaques before treatment and with each visit till the end of the treatment course. The TES score is the sum of the scores given to each individual parameter (thickness, erythema and scale)
Measured: 6 month
to look into how both therapy modalities affect individuals with psoriasis in terms of how their quality of life is improved.
Dermatology Life Quality Index (DLQI) is used for quality of life assessment. The DLQI is a validated, 10-question, self-reported questionnaire. It was done to evaluate the patient's perception of the impact of psoriasis on quality of life before and at the end of the treatment course of both groups (14, 15). The DLQI questionnaire was divided into 6 commonly identified categories. The DLQI was rated on a 4-point scale (0 = not at all to 3 = very much). The highest possible total score for the DLQI is 30 and higher scores indicate more severe impact on quality of life (16). According to the score of the DLQI the impact of psoriasis on QOL is then graded into: no effect at all on patient's life (0-1), small effect (2-5), moderate effect (6-10), very large effect (11-20) and extremely large effect on patient's life (21-30).
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Aug 2022
- Primary completion28 Feb 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Hasan Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011083
- Sponsor's protocol ID
- psoriasis vulgaris
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Griffiths CEM, Armstrong AW, Gudjonsson JE, Barker JNWN. Psoriasis. Lancet. 2021 Apr 3;397(10281):1301-1315. doi: 10.1016/S0140-6736(20)32549-6.
PubMed 33812489
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcipotriol /Betamethasone Ointment Versus Fractional CO2 Laser Plus Calcipotriol /Betamethasone Ointment in the Treatment of Plaque Psoriasis: Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT06011083
- Acronym / sponsor ID
- psoriasis vulgaris
- Conditions
- Psoriasis Vulgaris, Fractional CO2 Laser
- Keywords
- psoriasis vulgaris, fractional CO2 laser, Calcipotriol /Betamethasone Ointment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 25 Aug 2023 (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.
comparing the clinical efficacy of topical ointment containing calcipotriol and betamethasone dipropionate used alone with the simultaneous use of fractional carbon dioxide laser and the same topical ointment containing these two ingredients as treatment modalities for plaque psoriasis. Additionally, looking into how both therapy modalities affect individuals with psoriasis in terms of how their quality of life is improved.
Detailed description
Psoriasis is a widespread, persistent papulosquamous skin condition that can affect anyone at any age and places a heavy strain on both the individual and society. It is linked to a number of serious medical disorders, such as cardiometabolic syndrome, depression, and psoriatic arthritis (1).
Patients with psoriasis indicate that the condition interferes with their ability to sleep and rest, limits their everyday activities, particularly their mobility, and stigmatises them and causes problems in their social lives. Additionally, psoriasis can negatively impact mental health. Many psoriasis sufferers struggle with addiction, anxiety, and depression (2, 3).
Topical medicines continue to be the basis of treatment for those with mild psoriasis, and they include topical corticosteroids, vitamin D analogues, calcineurin inhibitors, and keratolytics (4).
For the topical management of mild psoriasis, preparations containing calcipotriol in combination with betamethasone (in the form of betamethasone dipropionate) are available (5). In comparison to the effects of these active substances when given separately, pharmacodynamic investigations demonstrated the synergy between the anti-inflammatory and immunoregulatory actions of calcipotriol and betamethasone dipropionate (6). The synergistic activity of the two drugs is what makes calcipotriol/betamethasone dipropionate combinations successful. Betamethasone impacts inflammatory processes and lessens skin irritation and pruritus following calcipotriol administration, while calcipotriol alters keratinocyte differentiation (7).
Fractional lasers were used in the treatment of dermatological diseases. They create tiny ablation channels in the skin that act as shunts for topically applied medications, particularly those with high molecular weights (8), by ablation of the skin in the form of fractions and splitting laser beams into microbeams (9).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm20 patients who were treated with Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm twice daily as a monotherapy for 3 months over a selected psoriatic plaque |
| Group B | Active comparator | Drug: Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm, Device: Fractional carbon dioxide (CO2) laser20 patients who were treated with fractional CO2 laser sessions once per month followed by application of the same Topical Ointment twice daily for 3 months over a similar psoriatic plaque |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with chronic plaque psoriasis of either sex.
- Aged more than 18 years of age.
Key exclusion criteria (6 listed)
- Pregnant and lactating women.
- Patients with severe skin infection.
- Patients who are under systemic ttt or phototherapy in the last 3 months.
- Immunosuppression or being under any kind of treatment causingabsolute or relative immunosuppression
- History of any bleeding, clotting disorder or using anticoagulants.
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 |
|---|---|---|
| Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gmusing topical ointment containing calcipotriol and betamethasone dipropionate for plaque psoriasis. | Drug | Group A, Group B |
| Fractional carbon dioxide (CO2) laserfractional CO2 laser sessions once per month for 3 months over a similar psoriatic plaque | Device | Group B |
Primary outcome
Evaluating the reduction in the severity of the treated psoriatic plaques using Psoriasis severity (TES) score before treatment and after the treatment course in both groups.
Time frame: 6 month
Group A included 20 patients who were treated with Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm applied twice daily as a monotherapy for 3 months over a selected psoriatic plaque while Group B included 20 patients who were treated with fractional CO2 laser sessions once per month followed by application of the same topical ointment twice daily for 3 months over a similar psoriatic plaque [as regard anatomical site, size and TES (thickness, erythema, scales) score]. We used a physician-based, four-point scoring system in which the thickness, erythema, and scale within each plaque was rated from 0 (none) to 3 (severe) to evaluate the changes in the severity of individual psoriatic plaques before treatment and with each visit till the end of the treatment course. The TES score is the sum of the scores given to each individual parameter (thickness, erythema and scale)
to look into how both therapy modalities affect individuals with psoriasis in terms of how their quality of life is improved.
Time frame: 6 month
Dermatology Life Quality Index (DLQI) is used for quality of life assessment. The DLQI is a validated, 10-question, self-reported questionnaire. It was done to evaluate the patient's perception of the impact of psoriasis on quality of life before and at the end of the treatment course of both groups (14, 15). The DLQI questionnaire was divided into 6 commonly identified categories. The DLQI was rated on a 4-point scale (0 = not at all to 3 = very much). The highest possible total score for the DLQI is 30 and higher scores indicate more severe impact on quality of life (16). According to the score of the DLQI the impact of psoriasis on QOL is then graded into: no effect at all on patient's life (0-1), small effect (2-5), moderate effect (6-10), very large effect (11-20) and extremely large effect on patient's life (21-30).
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 25 Aug 2023.
- Background: PubMed 33812489Griffiths CEM, Armstrong AW, Gudjonsson JE, Barker JNWN. Psoriasis. Lancet. 2021 Apr 3;397(10281):1301-1315. doi: 10.1016/S0140-6736(20)32549-6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm and Fractional carbon dioxide (CO2) laser in people with Psoriasis Vulgaris and Fractional CO2 Laser, run by Assiut University at 1 site in Egypt.
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 6 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 25 Aug 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 Egypt. 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?
Evaluating the reduction in the severity of the treated psoriatic plaques using Psoriasis severity (TES) score before treatment and after the treatment course in both groups. (time frame: 6 month). The study lists 2 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 NCT06011083, which also lists 1 linked publication.
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 25 Aug 2023.