VitiligoPhase 1/2NCT03358082
Effectivness of Topical Tacrolimus Monotherapy in Patients With Vitiligo
A Phase 1/2 study testing Tacrolimus 0.03% Ointment and Hydrocortisone Acetate 1% Ointment in people with Vitiligo and Tacrolimus, run by Sohag University at 1 site in Egypt.
Trial summary
The study will evaluate the effectiveness of Tacrolimus 0.03% ointment monotherapy in patients with vitiligo. Patients will be treated for 6 months and followed for 3 months after treatment. All types of vitiligo will be included. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Vitiligo, Tacrolimus
- What is being tested?
- Tacrolimus 0.03% Ointment and Hydrocortisone Acetate 1% Ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2017to 1 Feb 2019
- Phase
- Phase 1/2
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients with clinical diagnosis of vitiligo
Who cannot join
- children =or <2 years old, women who are pregnant or lactating, patients with acute or chronic disease that might affect skin barrier function.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag
Aml Ahmed, MBBCH, 01093801703, hanodymody12@gmail.com
Ramadan Saleh, MD, 01005423054, salehr2010@yahoo.com
About this study
Official title: Effectivness of Topical Tacrolimus 0.03% Monotherapy in Patients With Vitiligo: Arandomized Controlled Trial
The study will evaluate the effectiveness of Tacrolimus 0.03% ointment monotherapy in patients with vitiligo. Patients will be treated for 6 months and followed for 3 months after treatment. All types of vitiligo will be included.
Read the detailed description
Study approval: The study was submitted for approval by Scientific and Ethical Committee at Faculty of Medicine, Sohag University. An informed written consent will be obtained from all participants.
Study design: randomized controlled trial. Study population: the study will include patients who attend the outpatient Clinic of Dermatology \& Venereology and Andrology, Faculty of Medicine, Sohag University in corporation with Farshot General Hospital. Women who are pregnant or lactating, children aged 2 years or less and patients with acute or chronic disease that might affect skin barrier function will be excluded.
Patients and methods:
Study participants will be randomly divided into two treatment groups: group A will receive 0.03% tacrolimus ointment and group B will receive hydrocortisone acetate 1% ointment twice daily for 6 months.
Patients will be evaluated at baseline and monthly intervals for 6 months and at 3 months after stopping treatment.
- Conditions
- Vitiligo, Tacrolimus
- Being tested
- Tacrolimus 0.03% Ointment, Hydrocortisone Acetate 1% Ointment
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus 0.03% OintmentDrug
Also called Tarolimus ointment
topical tacrolimus 0.03% twice daily for 6 months
Hydrocortisone Acetate 1% OintmentDrug
Also called Texacort ointment
hydrocortisone acetate 1% ointment twice daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus group | Active comparator | Tacrolimus 0.03% ointment twice daily for 6 months Receives: Drug: Tacrolimus 0.03% Ointment |
| Hydrocortisone group | Active comparator | hydrocortisone acetate 1% ointment twice daily for 6 months Receives: Drug: Hydrocortisone Acetate 1% Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitiligo Area Scoring Index (VASI)
- The percentage of vitiligo involvement for each body region is calculated by using the palmar method. The palmar method uses the palmar surface area of the patient's hand as an estimation guide and defines the surface of the patient's hand including fingers to be 1% of the total body surface area.
- The extent of residual depigmentation is expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%.
- At 100% depigmentation, no pigment is present; at 90%, specks of pigment are present; at 75%, the depigmented area exceeds the pigmented area; at 50%, the depigmented and pigmented areas are equal; at 25%, the pigmented area exceeds the depigmented area; at 10%, only specks of depigmentation are present.
- VASI= ∑ [HAND UNITS] × [RESIDUAL DEPIGMENTATION].
Measured: basline to 9 months
Secondary outcomes (1)
Vitiligo Disease Activity (VIDA) Score
): is a six-point scale for evaluating vitiligo activity.
- In this score grading is based on disease activity and time period. Grading is as follows: + 4: (activity lasting 6 weeks or less); score +3: (activity lasting 6 weeks to 3 months); score 2: (activity lasting 3-6 months); score1: (activity lasting 6-12 months); score 0: (stable for 1 year or more); score -1: (stable with spontaneous repigmentation for 1 year or more).
- A low Vitiligo disease activity score indicate less vitiligo activity.
Measured: baseline to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start1 Oct 2017
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Feb 2019 (estimated)
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.
- More trials run by Sohag 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aml Abd Elaziz Ahmed, Sohag University
- Investigators
- Ramadan Saleh, MD, Study director, Sohag Faculty of Medicine, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358082
- Sponsor's protocol ID
- Tacvit01
- Status last verified
- Nov 2017
- First submitted
- 12 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivness of Topical Tacrolimus 0.03% Monotherapy in Patients With Vitiligo: Arandomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03358082
- Acronym / sponsor ID
- Tacvit01
- Conditions
- Vitiligo, Tacrolimus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 30 Nov 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 study will evaluate the effectiveness of Tacrolimus 0.03% ointment monotherapy in patients with vitiligo. Patients will be treated for 6 months and followed for 3 months after treatment. All types of vitiligo will be included.
Detailed description
Study approval: The study was submitted for approval by Scientific and Ethical Committee at Faculty of Medicine, Sohag University. An informed written consent will be obtained from all participants.
Study design: randomized controlled trial. Study population: the study will include patients who attend the outpatient Clinic of Dermatology \& Venereology and Andrology, Faculty of Medicine, Sohag University in corporation with Farshot General Hospital. Women who are pregnant or lactating, children aged 2 years or less and patients with acute or chronic disease that might affect skin barrier function will be excluded.
Patients and methods:
Study participants will be randomly divided into two treatment groups: group A will receive 0.03% tacrolimus ointment and group B will receive hydrocortisone acetate 1% ointment twice daily for 6 months.
Patients will be evaluated at baseline and monthly intervals for 6 months and at 3 months after stopping treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus group | Active comparator | Drug: Tacrolimus 0.03% OintmentTacrolimus 0.03% ointment twice daily for 6 months |
| Hydrocortisone group | Active comparator | Drug: Hydrocortisone Acetate 1% Ointmenthydrocortisone acetate 1% ointment twice daily for 6 months |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients with clinical diagnosis of vitiligo
Key exclusion criteria (1 listed)
- children =or <2 years old, women who are pregnant or lactating, patients with acute or chronic disease that might affect skin barrier function.
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 |
|---|---|---|
| Tacrolimus 0.03% OintmentAlso: Tarolimus ointmenttopical tacrolimus 0.03% twice daily for 6 months | Drug | Tacrolimus group |
| Hydrocortisone Acetate 1% OintmentAlso: Texacort ointmenthydrocortisone acetate 1% ointment twice daily for 6 months | Drug | Hydrocortisone group |
Primary outcome
Vitiligo Area Scoring Index (VASI)
Time frame: basline to 9 months
* The percentage of vitiligo involvement for each body region is calculated by using the palmar method. The palmar method uses the palmar surface area of the patient's hand as an estimation guide and defines the surface of the patient's hand including fingers to be 1% of the total body surface area. * The extent of residual depigmentation is expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. * At 100% depigmentation, no pigment is present; at 90%, specks of pigment are present; at 75%, the depigmented area exceeds the pigmented area; at 50%, the depigmented and pigmented areas are equal; at 25%, the pigmented area exceeds the depigmented area; at 10%, only specks of depigmentation are present. * VASI= ∑ [HAND UNITS] × [RESIDUAL DEPIGMENTATION].
1 secondary outcome
Vitiligo Disease Activity (VIDA) Score
Time frame: baseline to 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
Ramadan Saleh, MD study director
Sohag Faculty of Medicine, Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tacrolimus 0.03% Ointment and Hydrocortisone Acetate 1% Ointment in people with Vitiligo and Tacrolimus, run by Sohag 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Nov 2017. 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aml Ahmed, MBBCH (01093801703, hanodymody12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitiligo Area Scoring Index (VASI) (time frame: basline to 9 months). 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 30 Nov 2017.