VitiligoNCT00368407
Optimal Treatment Frequency of 308-Nm Excimer Laser for Vitiligo on the Face and Neck
An observational study of Vitiligo, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
To determine the optimal treatment frequency of 308-nm excimer laser for vitiligo and identify the key clinical variable(s) associated with the treatment efficiency under the optimal treatment frequency. Read more about this study
- Who is it for?
- Ages 2 to 60 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- 308-nm excimer laser
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteChina
- Study dates
- Apr 2005to Jul 2006
- Phase
- Observational
- 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 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- older than 2 years, stable vitiliginous patches during the past 3 months with surfaces of at least 4cm2, and an understanding of all information given by signing a written consent form.
Who cannot join
- pregnant or breastfeeding women; personal history of a hypertrophic scar, skin cancer; taking immunosuppressive or photosensitizing drugs and undergoing phototherapy during the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
To determine the optimal treatment frequency of 308-nm excimer laser for vitiligo and identify the key clinical variable(s) associated with the treatment efficiency under the optimal treatment frequency.
Prospective, randomized, comparative study among groups of vitiligo patients treated with 308-nm excimer laser, with the limitation of no follow-up.
Read the detailed description
Vitiligo patients were treated with 308-nm excimer laser for 20 sessions at different frequencies (0.5×, 1.0×, 2.0× and 3.0× weekly). Treatment protocols adapted the dose to the lesions and not to the minimal erythemal dose. Treatment efficacy was blindly evaluated by 2 independent physicians. Re-pigmentation rate was graded on a 6-point scale. The onset of re-pigmentation of vitiligo lesions was evaluated after 5 treatment sessions. The differences between Group 0.5×, 1.0×, 2.0× and 3.0× linking different clinical variables were assessed.
- Conditions
- Vitiligo
- Being tested
- 308-nm excimer laser
- Keywords
- 308-nm excimer laser, vitiligo
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
308-nm excimer laserDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2006 (estimated)
- Study startApr 2005
- Study completionJul 2006
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 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
- Observational
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Investigators
- gao tianwen, MD,PHD, Study director, Ddepartment of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368407
- Sponsor's protocol ID
- fmmu200504
- Status last verified
- Apr 2005
- First submitted
- 23 Aug 2006
- Last updated
- 24 Aug 2006
- Results posted
- No
Publications
Hofer A, Hassan AS, Legat FJ, Kerl H, Wolf P. Optimal weekly frequency of 308-nm excimer laser treatment in vitiligo patients. Br J Dermatol. 2005 May;152(5):981-5. doi: 10.1111/j.1365-2133.2004.06321.x.
PubMed 15888156
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Treatment Frequency of 308-Nm Excimer Laser for Vitiligo on the Face and Neck
- ClinicalTrials.gov ID
- NCT00368407
- Acronym / sponsor ID
- fmmu200504
- Conditions
- Vitiligo
- Keywords
- 308-nm excimer laser, vitiligo
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Jul 2006
- First posted
- 24 Aug 2006 (estimated)
- 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.
To determine the optimal treatment frequency of 308-nm excimer laser for vitiligo and identify the key clinical variable(s) associated with the treatment efficiency under the optimal treatment frequency.
Prospective, randomized, comparative study among groups of vitiligo patients treated with 308-nm excimer laser, with the limitation of no follow-up.
Detailed description
Vitiligo patients were treated with 308-nm excimer laser for 20 sessions at different frequencies (0.5×, 1.0×, 2.0× and 3.0× weekly). Treatment protocols adapted the dose to the lesions and not to the minimal erythemal dose. Treatment efficacy was blindly evaluated by 2 independent physicians. Re-pigmentation rate was graded on a 6-point scale. The onset of re-pigmentation of vitiligo lesions was evaluated after 5 treatment sessions. The differences between Group 0.5×, 1.0×, 2.0× and 3.0× linking different clinical variables were assessed.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- older than 2 years, stable vitiliginous patches during the past 3 months with surfaces of at least 4cm2, and an understanding of all information given by signing a written consent form.
Key exclusion criteria (1 listed)
- pregnant or breastfeeding women; personal history of a hypertrophic scar, skin cancer; taking immunosuppressive or photosensitizing drugs and undergoing phototherapy during the past 3 months.
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 |
|---|---|---|
| 308-nm excimer laser | Device | – |
Primary outcome
Not reported in the source record.
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 24 Aug 2006.
- Results publication: PubMed 15888156Hofer A, Hassan AS, Legat FJ, Kerl H, Wolf P. Optimal weekly frequency of 308-nm excimer laser treatment in vitiligo patients. Br J Dermatol. 2005 May;152(5):981-5. doi: 10.1111/j.1365-2133.2004.06321.x.
Related trials for Vitiligo
RecruitingPhase 2
A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
Non-Segmental Vitiligo (NSV)
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Not yet recruitingPhase 2/3
Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
Vitiligo
RecruitingPhase 2
A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
Vitiligo, Non-Segmental Vitiligo (NSV)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Nonsegmental Vitiligo
Nonsegmental Vitiligo
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.
gao tianwen, MD,PHD study director
Ddepartment of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitiligo, run by Air Force Military Medical University, China at 1 site in China.
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: finished, as of the sponsor's last update on 24 Aug 2006. 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 China. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00368407, 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 24 Aug 2006.