VitiligoPhase 1NCT05577637
Comparitive Study Between Uvb Alone and Uvb With Topical Tacrolimus 0.03% for the Treatment of Vitiligo
A Phase 1 study testing 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily in people with Vitiligo, run by Combined Military Hospital Abbottabad at 1 site in Pakistan.
Trial summary
Vitiligo is a skin disorder that causes substantial social and psychological distress due to multiple patches of depigmentation.Disease can target at any age, but it appears to affect various parts of body due to loss of melanin. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2021to 30 Nov 2021
- Phase
- Phase 1
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients having 20-60 years of age
- non pregnant
- no history of photosensitivity
- no history of immunosuppression or immunosuppressive drugs
- no histry of steroids use oral or topical in last four weeks
Who cannot join
- pregnancy
- lactation
- history of photosensitivity
- photo-aggravated dermatoses
- history of any immunosuppressive disorder or use of immunosuppressive medicine
- history of using steroids either oral or injectable within the previous one month
- history of skin malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparitive Study Between Uvb Phototherapy Alone and Uvb Photothearpy With Topical 0.03% Tacrolimus for Treatment of Vitiligo
Vitiligo is a skin disorder that causes substantial social and psychological distress due to multiple patches of depigmentation.Disease can target at any age, but it appears to affect various parts of body due to loss of melanin. Although the exact cause of the disease is unknown, several theories suggest that genetic predisposition, autoimmunity, and increased vulnerability of melanocytes to the deleterious effects of harmful metabolites all play a role in disease causation. It impacts 0.1%-2% of the general population, with a 30% familial prevalence rate.
Vitiligo treatment still presents a therapeutic challenge for dermatologists despite a variety of therapeutic modalities. Topical steroids, ultraviolet B phototherapy (UVB 280nm-320nm), and photochemotherapy (PUVA i.e., psoralen plus UVA 329nm-400nm) are traditional treatment options. Topical calcipotriol and excimer laser are also used. According to research, narrowband UVB (NB-UVB) is effective when used alone.
Read more
Few studies, however also, have reported more than 75% re-pigmentation in patients treated with NB-UVB in conjunction with other modalities. Topical immunomodulators (tacrolimus, pimecrolimus) are considered safe and effective long-term treatments for vitiligo because they do not cause skin atrophy, which is associated with long-term use of topical corticosteroids. Tacrolimus is an effective treatment for vitiligo when used alone; in one study, 61% of patients showed more than 75% repigmentation when treated with tacrolimus alone. Another study found that when tacrolimus was combined with NB-UVB, 73% of patients experienced more than 50% repigmentation.
The objective of this research was to present a comparatively new mode of treatment that may be beneficial to vitiligo patients.
- Conditions
- Vitiligo
- Being tested
- 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily
- Keywords
- Phototherapy, tacrolimus, vitiligo
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice dailyDrug
Also called ointment eczemus
0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily
| Study group | Role | What they receive |
|---|---|---|
| group A topical tacrolimus 0.03% with uvb phototherapy | Active comparator | Group A :contain 30 patients who have been treated with topical 0.03% tacrolimus twice daily at night and then received uvb phototherapy thrice weekly for 12 weeks Receives: Drug: 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily |
| Group B topical placebo twice daily with uvb phototherapy thrice weekly | Active comparator | Group B :contain 30 patients received uvb phototherapy only thrice weekly for 12 weeks Receives: Drug: 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of 0.03% topical tacrolimus with uvb phototherapy and placebo with uvb photothreapy is calculated through repigmentation using a formula {% re-pigmentation = Present % depigmentation ÷ Baseline % depigmentation x 100}
repigmentation assesed by {% re-pigmentation = Present % depigmentation ÷ Baseline % depigmentation x 100}
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 posted13 Oct 2022
- Study start1 May 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital Abbottabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rohida Rahmat, Combined Military Hospital Abbottabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577637
- Sponsor's protocol ID
- CMHAtd-26-Derm-22
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparitive Study Between Uvb Phototherapy Alone and Uvb Photothearpy With Topical 0.03% Tacrolimus for Treatment of Vitiligo
- ClinicalTrials.gov ID
- NCT05577637
- Acronym / sponsor ID
- CMHAtd-26-Derm-22
- Conditions
- Vitiligo
- Keywords
- Phototherapy, tacrolimus, vitiligo
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Combined Military Hospital AbbottabadUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 13 Oct 2022 (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.
Vitiligo is a skin disorder that causes substantial social and psychological distress due to multiple patches of depigmentation.Disease can target at any age, but it appears to affect various parts of body due to loss of melanin. Although the exact cause of the disease is unknown, several theories suggest that genetic predisposition, autoimmunity, and increased vulnerability of melanocytes to the deleterious effects of harmful metabolites all play a role in disease causation. It impacts 0.1%-2% of the general population, with a 30% familial prevalence rate.
Vitiligo treatment still presents a therapeutic challenge for dermatologists despite a variety of therapeutic modalities. Topical steroids, ultraviolet B phototherapy (UVB 280nm-320nm), and photochemotherapy (PUVA i.e., psoralen plus UVA 329nm-400nm) are traditional treatment options. Topical calcipotriol and excimer laser are also used. According to research, narrowband UVB (NB-UVB) is effective when used alone.
Few studies, however also, have reported more than 75% re-pigmentation in patients treated with NB-UVB in conjunction with other modalities. Topical immunomodulators (tacrolimus, pimecrolimus) are considered safe and effective long-term treatments for vitiligo because they do not cause skin atrophy, which is associated with long-term use of topical corticosteroids. Tacrolimus is an effective treatment for vitiligo when used alone; in one study, 61% of patients showed more than 75% repigmentation when treated with tacrolimus alone. Another study found that when tacrolimus was combined with NB-UVB, 73% of patients experienced more than 50% repigmentation.
The objective of this research was to present a comparatively new mode of treatment that may be beneficial to vitiligo patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A topical tacrolimus 0.03% with uvb phototherapy | Active comparator | Drug: 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice dailyGroup A :contain 30 patients who have been treated with topical 0.03% tacrolimus twice daily at night and then received uvb phototherapy thrice weekly for 12 weeks |
| Group B topical placebo twice daily with uvb phototherapy thrice weekly | Active comparator | Drug: 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice dailyGroup B :contain 30 patients received uvb phototherapy only thrice weekly for 12 weeks |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- patients having 20-60 years of age
- non pregnant
- no history of photosensitivity
- no history of immunosuppression or immunosuppressive drugs
- no histry of steroids use oral or topical in last four weeks
Key exclusion criteria (7 listed)
- pregnancy
- lactation
- history of photosensitivity
- photo-aggravated dermatoses
- history of any immunosuppressive disorder or use of immunosuppressive medicine
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 |
|---|---|---|
| 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice dailyAlso: ointment eczemus0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily | Drug | Group B topical placebo twice daily with uvb phototherapy thrice weekly, group A topical tacrolimus 0.03% with uvb phototherapy |
Primary outcome
effectiveness of 0.03% topical tacrolimus with uvb phototherapy and placebo with uvb photothreapy is calculated through repigmentation using a formula {% re-pigmentation = Present % depigmentation ÷ Baseline % depigmentation x 100}
Time frame: 12 weeks
repigmentation assesed by {% re-pigmentation = Present % depigmentation ÷ Baseline % depigmentation x 100}
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 17 Oct 2022.
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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 Phase 1 study testing 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily in people with Vitiligo, run by Combined Military Hospital Abbottabad at 1 site in Pakistan.
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 7 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 17 Oct 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 Pakistan. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
effectiveness of 0.03% topical tacrolimus with uvb phototherapy and placebo with uvb photothreapy is calculated through repigmentation using a formula {% re-pigmentation = Present % depigmentation ÷ Baseline % depigmentation x 100} (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2022.