Vitiligo VulgarisPhase 1NCT03234673
The Effect of Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or NB-UVB in Stable Generalized Vitiligo
A Phase 1 study testing Tacrolimus ointment, calcipotriol ointment and NB-UVB in people with Vitiligo Vulgaris, run by Assiut University.
Trial summary
Vitiligo is an acquired disorder of the skin and mucous membranes characterized by well circumscribed depigmented macules and patches that occur secondary to selective destruction of melanocytes (Zhang et al., 2009). Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Vitiligo Vulgaris
- What is being tested?
- Tacrolimus ointment, calcipotriol ointment and NB-UVB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to Jan 2019
- 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients with stable vitiligo
- nonsegmental vitiligo will be recruited
- A patient reporting no new lesions, no progression of existing lesions, and absence of Koebner phenomenon during the previous year
Who cannot join
- Patients with active infection.
- Reported histories of koebnerization.
- History of keloid formation or hypertrophic scars.
- Pregnant or lactating females.
- Bleeding tendency.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Preceding Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or With NB-UVB in the Treatment of Stable Generalized Vitiligo
Vitiligo is an acquired disorder of the skin and mucous membranes characterized by well circumscribed depigmented macules and patches that occur secondary to selective destruction of melanocytes (Zhang et al., 2009).
Generalized vitiligo is the most common clinical presentation and often involves the face and acral regions (Alikhan et al., 2011).
Read the detailed description
Combined vitiligo treatments have been found to be superior to monotherapies regarding efficacy, early response and safety (Kandaswamy et al., 2013).
Fractionated lasers represent a new modality for skin resurfacing based on the theory of fractional photothermolysis introduced by Manstein et al (2004). These lasers were shown to be efficient in treating facial photo aging changes as well as scars, and have an improved safety and recovery profile compared with traditional CO2 laser resurfacing. Fractionated lasers do not ablate the entire epidermis and thereafter leave intact skin between coagulated necrotic columns. This characteristic facilitates the skin healing process (Bogdan et al., 2010)
- Conditions
- Vitiligo Vulgaris
- Being tested
- Tacrolimus ointment, calcipotriol ointment, NB-UVB
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus ointmentDrug
Also called tarolimus ointment
3 sessions of fractional CO2 laser one month apart Patients will start treatment Tarolimus ointment twice daily for 3 months.
calcipotriol ointmentDrug
Also called calcipoheal
3 sessions of fractional CO2 laser one month apart Patients will start treatment Calcipotriol ointment twice daily for 3 months.
NB-UVBDrug
Also called narrow band ultraviolet rays B
3 sessions of fractional CO2 laser one month apart Patients will start treatment NB-UVB phototherapy twice weekly for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Group A (Tacrolimus group): | Experimental | fractional CO2 laser therapy and Tacrolimus ointment 1 Receives: Drug: Tacrolimus ointment |
| Group B (Calcipotriol group): | Experimental | fractional CO2 laser therapy and Calcipotriol ointment Receives: Drug: calcipotriol ointment |
| Group C (NB-UVB group): | Experimental | fractional CO2 laser therapy and NB-UVB twice weekly Receives: Drug: NB-UVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
1- Re-pigmentation : that will be subjectively rated with a previously reported scoring system (Ghiya et al., 2016).
G0, < 25% repigmentation (poor)
- G1, 25-50% repigmentation (fair)
- G2, 50-75% repigmentation (good)
- G3 > 75% repigmentation (excellent).
Measured: up to 3 months
Secondary outcomes (1)
The VASI percent change
The VASI percent change will be calculated by subtracting the pre- procedure VASI score from the post-procedure VASI score and dividing by the pre-procedure VASI score.
Measured: every month for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study startAug 2017 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vitiligo 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Mostafa Tawfik, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234673
- Sponsor's protocol ID
- TEOPFCLEWTCOWNITTOSGV
- Status last verified
- Jul 2017
- First submitted
- 27 Jul 2017
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015 Jul 4;386(9988):74-84. doi: 10.1016/S0140-6736(14)60763-7. Epub 2015 Jan 15.
PubMed 25596811Kandaswamy S, Akhtar N, Ravindran S, Prabhu S, Shenoi SD. Phototherapy in Vitiligo: Assessing the Compliance, Response and Patient's Perception about Disease and Treatment. Indian J Dermatol. 2013 Jul;58(4):325. doi: 10.4103/0019-5154.113944.
PubMed 23919018Bogdan Allemann I, Kaufman J. Fractional photothermolysis--an update. Lasers Med Sci. 2010 Jan;25(1):137-44. doi: 10.1007/s10103-009-0734-8.
PubMed 19787413Wong L, Vasconez HC. Patient satisfaction after Nd:YAG laser-assisted lipolysis. Ann Plast Surg. 2011 May;66(5):561-3. doi: 10.1097/SAP.0b013e31820b3d1e.
PubMed 21451378
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preceding Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or With NB-UVB in the Treatment of Stable Generalized Vitiligo
- ClinicalTrials.gov ID
- NCT03234673
- Acronym / sponsor ID
- TEOPFCLEWTCOWNITTOSGV
- Conditions
- Vitiligo Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 31 Jul 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.
Vitiligo is an acquired disorder of the skin and mucous membranes characterized by well circumscribed depigmented macules and patches that occur secondary to selective destruction of melanocytes (Zhang et al., 2009).
Generalized vitiligo is the most common clinical presentation and often involves the face and acral regions (Alikhan et al., 2011).
Detailed description
Combined vitiligo treatments have been found to be superior to monotherapies regarding efficacy, early response and safety (Kandaswamy et al., 2013).
Fractionated lasers represent a new modality for skin resurfacing based on the theory of fractional photothermolysis introduced by Manstein et al (2004). These lasers were shown to be efficient in treating facial photo aging changes as well as scars, and have an improved safety and recovery profile compared with traditional CO2 laser resurfacing. Fractionated lasers do not ablate the entire epidermis and thereafter leave intact skin between coagulated necrotic columns. This characteristic facilitates the skin healing process (Bogdan et al., 2010)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (Tacrolimus group): | Experimental | Drug: Tacrolimus ointmentfractional CO2 laser therapy and Tacrolimus ointment 1 |
| Group B (Calcipotriol group): | Experimental | Drug: calcipotriol ointmentfractional CO2 laser therapy and Calcipotriol ointment |
| Group C (NB-UVB group): | Experimental | Drug: NB-UVBfractional CO2 laser therapy and NB-UVB twice weekly |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- patients with stable vitiligo
- nonsegmental vitiligo will be recruited
- A patient reporting no new lesions, no progression of existing lesions, and absence of Koebner phenomenon during the previous year
Key exclusion criteria (5 listed)
- Patients with active infection.
- Reported histories of koebnerization.
- History of keloid formation or hypertrophic scars.
- Pregnant or lactating females.
- Bleeding tendency.
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 ointmentAlso: tarolimus ointment3 sessions of fractional CO2 laser one month apart Patients will start treatment Tarolimus ointment twice daily for 3 months. | Drug | Group A (Tacrolimus group): |
| calcipotriol ointmentAlso: calcipoheal3 sessions of fractional CO2 laser one month apart Patients will start treatment Calcipotriol ointment twice daily for 3 months. | Drug | Group B (Calcipotriol group): |
| NB-UVBAlso: narrow band ultraviolet rays B3 sessions of fractional CO2 laser one month apart Patients will start treatment NB-UVB phototherapy twice weekly for 3 months | Drug | Group C (NB-UVB group): |
Primary outcome
1- Re-pigmentation : that will be subjectively rated with a previously reported scoring system (Ghiya et al., 2016).
Time frame: up to 3 months
G0, < 25% repigmentation (poor) * G1, 25-50% repigmentation (fair) * G2, 50-75% repigmentation (good) * G3 > 75% repigmentation (excellent).
1 secondary outcome
The VASI percent change
Time frame: every month for 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Results publication: PubMed 25596811Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015 Jul 4;386(9988):74-84. doi: 10.1016/S0140-6736(14)60763-7. Epub 2015 Jan 15.
- Results publication: PubMed 23919018Kandaswamy S, Akhtar N, Ravindran S, Prabhu S, Shenoi SD. Phototherapy in Vitiligo: Assessing the Compliance, Response and Patient's Perception about Disease and Treatment. Indian J Dermatol. 2013 Jul;58(4):325. doi: 10.4103/0019-5154.113944.
- Results publication: PubMed 19787413Bogdan Allemann I, Kaufman J. Fractional photothermolysis--an update. Lasers Med Sci. 2010 Jan;25(1):137-44. doi: 10.1007/s10103-009-0734-8.
- Results publication: PubMed 21451378Wong L, Vasconez HC. Patient satisfaction after Nd:YAG laser-assisted lipolysis. Ann Plast Surg. 2011 May;66(5):561-3. doi: 10.1097/SAP.0b013e31820b3d1e.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tacrolimus ointment, calcipotriol ointment and NB-UVB in people with Vitiligo Vulgaris, run by Assiut University.
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 3 inclusion and 5 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 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yasmin tawfik, MD (01006033331, dr.yasminmostawfik@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1- Re-pigmentation : that will be subjectively rated with a previously reported scoring system (Ghiya et al., 2016). (time frame: up to 3 months). 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 NCT03234673, which also lists 4 linked publications.
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 1 Aug 2017.