Stable VitiligoNCT03535051
Efficiency of Fractional-Laser Resurfacing Followed by Topical Tacrolimus 0.03% Cream vs Tacrolimus Alone in Vitiligo
A study testing fractional carbon dioxide laser and Tacrolimus Oint 0.03% in people with Stable Vitiligo, run by Kasr El Aini Hospital.
Trial summary
The aim the clinical trial was to find out whether fractional CO₂ laser sessions in combination with application of daily topical tacrolimus 0.03% would enhance the action of the drug and pose as a possible combination treatment option for stable vitiligo lesions. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Stable Vitiligo
- What is being tested?
- fractional carbon dioxide laser and Tacrolimus Oint 0.03%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Feb 2017
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with stable vitiligo for at least 6 months, stability being defined as no eruption of fresh lesions and no extension of pre-existing lesions.
- Age ≧ 12 years.
- Symmetrical vitiligo.
- Three month treatment-free period.
Who cannot join
- Patients younger than 12 years of age.
- Non-stable lesions.
- Non-symmetrical vitiligo.
- Patients currently on other lines of treatment.
About this study
Official title: The Efficiency of Fractional-Laser Resurfacing Followed by Topical Tacrolimus 0.03% Cream Versus Topical Tacrolimus Alone in Stable Vitiligo: a Comparative Study
The aim the clinical trial was to find out whether fractional CO₂ laser sessions in combination with application of daily topical tacrolimus 0.03% would enhance the action of the drug and pose as a possible combination treatment option for stable vitiligo lesions. This combination treatment was applied to one side of the body and the response was compared to the response of the lesions on the other side of the body to daily topical tacrolimus 0.03% alone, which was used as control.
Read the detailed description
Each patient included in the study received treatment A on the lesions on one side of his/her body, and treatment B on the other side.
Treatment A included 4 monthly sessions of fractional CO₂ laser on the lesions plus application of topical tacrolimus 0.03% (Tarolimus) on the lesions 6 hours after each session and twice daily in between the sessions and for 1 month after the last session.
Treatment B included only the application of topical tacrolimus 0.03% (Tarolimus) on the lesions twice daily for 5 months.
Fractional laser The device used was DEKA, SmartXide DOT (Dermal Optical Thermolysis), Italy fractional Carbon Dioxide Laser (fig. 8). This device is an ablative fractional 10,6000 nm CO² Laser with variable pulse duration (0.2-2 ms), 350-μm beam spot size, scanner area of 15x15 mm and penetration depth between 200 to 1,500 μm.
Tacrolimus ointment 0.03% (Tarolimus) Applied on the lesions treated by fractional CO² laser 6 hours after each laser session, then twice daily in between the sessions and 1 month after the last session.
Applied on the lesions on the other half of the body (not treated with fractional CO² laser) twice daily for 4 months.
- Conditions
- Stable Vitiligo
- Being tested
- fractional carbon dioxide laser, Tacrolimus Oint 0.03%
- Keywords
- vitiligo, fractional carbon dioxide laser, tacrolimus, drug delivery
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractional carbon dioxide laserDevice
Also called fractional CO2 laser
Monthly fractional carbon dioxide laser sessions
Tacrolimus Oint 0.03%Drug
Also called Tacrolimus Oint 0.03% (Tarolimus)
topical daily tacrolimus ointment application
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Combination treatment of fractional carbon dioxide laser monthly sessions and topical tacrolimus 0.03% daily application (Tacrolimus Oint 0.03%) Receives: Device: fractional carbon dioxide laser; Drug: Tacrolimus Oint 0.03% |
| Treatment B | Active comparator | Monotherapy with only topical tacrolimus 0.03% daily intervention: Tacrolimus Oint 0.03% Receives: Drug: Tacrolimus Oint 0.03% |
What is being measured
The primary outcome is the main question the study is designed to answer.
repigmentation
reduction in Vitiligo Area Scoring Index of lesions
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start1 Jan 2015
- Primary completion1 Jan 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- A total of 152 lesions in different areas of the body were evaluated in the study. Seventy six lesions received the combination treatment and 76 received topical tacrolimus alone. Forty six lesions were in the head and neck region, 40 were acral in location, 36 were in the upper and lower limbs, 22 lesions were over bony prominences and 8 lesions were present on the trunk.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuhah Omar, Kasr El Aini Hospital
- Investigators
- Ola M AbuZeid, MD, Study director, Kasr Al Aini dermatology departmentDina ElSharkawy, MD, Study director, Kasr Al Aini dermatology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535051
- Sponsor's protocol ID
- 2
- Status last verified
- Sep 2018
- First submitted
- 12 May 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Fractional-Laser Resurfacing Followed by Topical Tacrolimus 0.03% Cream Versus Topical Tacrolimus Alone in Stable Vitiligo: a Comparative Study
- ClinicalTrials.gov ID
- NCT03535051
- Acronym / sponsor ID
- 2
- Conditions
- Stable Vitiligo
- Keywords
- vitiligo, fractional carbon dioxide laser, tacrolimus, drug delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 24 May 2018 (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 aim the clinical trial was to find out whether fractional CO₂ laser sessions in combination with application of daily topical tacrolimus 0.03% would enhance the action of the drug and pose as a possible combination treatment option for stable vitiligo lesions. This combination treatment was applied to one side of the body and the response was compared to the response of the lesions on the other side of the body to daily topical tacrolimus 0.03% alone, which was used as control.
Detailed description
Each patient included in the study received treatment A on the lesions on one side of his/her body, and treatment B on the other side.
Treatment A included 4 monthly sessions of fractional CO₂ laser on the lesions plus application of topical tacrolimus 0.03% (Tarolimus) on the lesions 6 hours after each session and twice daily in between the sessions and for 1 month after the last session.
Treatment B included only the application of topical tacrolimus 0.03% (Tarolimus) on the lesions twice daily for 5 months.
Fractional laser The device used was DEKA, SmartXide DOT (Dermal Optical Thermolysis), Italy fractional Carbon Dioxide Laser (fig. 8). This device is an ablative fractional 10,6000 nm CO² Laser with variable pulse duration (0.2-2 ms), 350-μm beam spot size, scanner area of 15x15 mm and penetration depth between 200 to 1,500 μm.
Tacrolimus ointment 0.03% (Tarolimus) Applied on the lesions treated by fractional CO² laser 6 hours after each laser session, then twice daily in between the sessions and 1 month after the last session.
Applied on the lesions on the other half of the body (not treated with fractional CO² laser) twice daily for 4 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A total of 152 lesions in different areas of the body were evaluated in the study. Seventy six lesions received the combination treatment and 76 received topical tacrolimus alone. Forty six lesions were in the head and neck region, 40 were acral in location, 36 were in the upper and lower limbs, 22 lesions were over bony prominences and 8 lesions were present on the trunk.
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Device: fractional carbon dioxide laser, Drug: Tacrolimus Oint 0.03%Combination treatment of fractional carbon dioxide laser monthly sessions and topical tacrolimus 0.03% daily application (Tacrolimus Oint 0.03%) |
| Treatment B | Active comparator | Drug: Tacrolimus Oint 0.03%Monotherapy with only topical tacrolimus 0.03% daily intervention: Tacrolimus Oint 0.03% |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with stable vitiligo for at least 6 months, stability being defined as no eruption of fresh lesions and no extension of pre-existing lesions.
- Age ≧ 12 years.
- Symmetrical vitiligo.
- Three month treatment-free period.
Key exclusion criteria (4 listed)
- Patients younger than 12 years of age.
- Non-stable lesions.
- Non-symmetrical vitiligo.
- Patients currently on other lines of treatment.
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 |
|---|---|---|
| fractional carbon dioxide laserAlso: fractional CO2 laserMonthly fractional carbon dioxide laser sessions | Device | Treatment A |
| Tacrolimus Oint 0.03%Also: Tacrolimus Oint 0.03% (Tarolimus)topical daily tacrolimus ointment application | Drug | Treatment A, Treatment B |
Primary outcome
repigmentation
Time frame: 5 months
reduction in Vitiligo Area Scoring Index of lesions
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 13 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Ola M AbuZeid, MD study director
Kasr Al Aini dermatology department
Dina ElSharkawy, MD study director
Kasr Al Aini dermatology department
Questions about this trial
What is this clinical trial studying?
A study testing fractional carbon dioxide laser and Tacrolimus Oint 0.03% in people with Stable Vitiligo, run by Kasr El Aini Hospital.
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 4 inclusion and 4 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 13 Sep 2018. 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.
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?
repigmentation (time frame: 5 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 13 Sep 2018.