VitiligoNCT05256147
Effect of Combination Non Steroidal Antiinflammatory Drugs and Narrowband UVB Treatment in Non-Photoadapters
A study testing Ibuprofen in people with Vitiligo, run by Henry Ford Health System at 1 site in United States.
Trial summary
Narrow band UVB phototherapy is the mainstay of therapy for vitiligo. However, about 1/3 of patients cannot respond to phototherapy. The objective of this study is to determine if the use of ibuprofen can induce non-photoadapters (patients who cannot tolerate increases in NBUVB past 400 mJ/cm2 after 12 sessions) to… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- What is being tested?
- Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 24 May 2016
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients should have a diagnosis of vitiligo.
- Patients who are identified as nonphotoadapters (those who cannot increase NBUVB dose past 400 mJ/cm2) will be recruited for the study
Who cannot join
- Patients with the daily ibuprofen use, history of renal disease, cardiac disease, gastric uler and bleeding disorder will be excluded from the study. Patients with a history of lupus erythematosus and other photosensitivity disorders will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Narrow band UVB phototherapy is the mainstay of therapy for vitiligo. However, about 1/3 of patients cannot respond to phototherapy. The objective of this study is to determine if the use of ibuprofen can induce non-photoadapters (patients who cannot tolerate increases in NBUVB past 400 mJ/cm2 after 12 sessions) to convert to photoadapters and tolerate raising NBUVB doses to therapeutic levels
Read the detailed description
Vitiligo is an acquired disorder of pigmentation. The depigmented regions present as white macules and patches and can occur at any age. The vitiligo patches may be asymptomatic, pruritic or may sunburn. Vitiligo has been shown to significantly impact the quality of life and also has an associated psychological burden. Therefore, treatment of vitiligo is essential. Various treatment modalities such as topical corticosteroids, topical calcineurin inhibitors, systemic steroids, surgery, and phototherapy exist to treat vitiligo. UV based phototherapy includes NBUVB, targeted phototherapy, psoralen and UVA photochemotherapy (1-3).
NBUVB is a proven, effective, and well-accepted treatment as part of the standard of care for vitiligo. NBUVB has a sharp emission peak at 311-313 nm. NBUVB is a relatively safe treatment modality, but can cause phototoxic reactions and tanning. Studies have shown that treatment with NBUVB improves the Vitiligo Area Scoring Index by 42% over a period of 6 months. Approximately half of patients should expect 50% repigmentation by 6 months of 2-3x per week phototherapy (4-6). However, a portion of patients are slow responders requiring up to 72 treatments before notable repigmentation has been achieved.
To complicate matters further, about 1/3 of the patients with vitiligo do not photoadapt, meaning the patient does not exhibit a diminished erythema (redness) to equivalent doses of NBUVB upon future irradiations (7). Photoadaption is the principle behind needing to increase the NBUVB dose for all phototherapy regimens (atopic dermatitis, psoriasis, mycosis fungiodes, vitiligo, etc) and why people are able to tolerate longer solar exposure at the end of summer rather than the beginning. It is thought that the non-photoadapters do not respond to NBUVB as their photoadpative capacity may be genetically predetermined (7).
Repigmentation from NBUVB therapy has shown dramatic improvements in quality of life scores (QOL). Tijoe et. al reported 70% improvement in QOL with long term UVB therapy (8). Therefore, identifying adjunctive therapies that can enable non-photoadapters to safely tolerate therapeutic NBUVB doses can significantly raise their QOL. In addition, these therapies can be expanded into the treatment of photoadapters receiving NBUVB to permit higher dose escalations and fewer phototherapy sessions to achieve a therapeutic NBUVB vitiligo dose. This can in-turn potentially decrease health care costs for increased treatments. Also, the patient may experience fewer long-term side effect associated with NBUVB since they may need fewer sessions of NBUVB.
A possible way for non-photoadapters to tolerate NBUVB may be with the use of NSAIDs. Studies performed have shown that the use of NSAIDs showed increased minimal erythema dose by possibly suppressing the immune response by inhibiting cyclooxygenase and prostaglandins (9). Ibuprofen has also shown to decrease inflammation induced by UVB phototherapy (10). Thus, ibuprofen may increase the MED in non-photoadapters.
Therefore, the goal of this study is to see if the use of ibuprofen, an NSAID, will allow for nonphotoadpaters to respond to NBUVB treatments.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Patient will receive ibuprofen 400 mg before the phototherapy session.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | There is one group in this study and they will receive ibuprofen 400 mg before their narrow band UVB phototherapy session which occurs two to three times weekly. The treatment dose of NBUVB will start off at 150 mJ/cm2 and will be increased 10% as tolerated til the patient reaches 700 mJ/cm2. They will receive ibuprofen before each phototherapy session. Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitiligo Area Scoring Index (VASI)
Investigator will assess surface area of vitiligo using VASI
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study startAug 2015
- Primary completion24 May 2016
- Study completion24 May 2016
Why it stopped: difficulty in recruiting study population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iltefat Hamzavi, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256147
- Sponsor's protocol ID
- 9744
- Status last verified
- Feb 2022
- First submitted
- 22 Feb 2017
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Alikhan A, Felsten LM, Daly M, Petronic-Rosic V. Vitiligo: a comprehensive overview Part I. Introduction, epidemiology, quality of life, diagnosis, differential diagnosis, associations, histopathology, etiology, and work-up. J Am Acad Dermatol. 2011 Sep;65(3):473-491. doi: 10.1016/j.jaad.2010.11.061.
PubMed 21839315Linthorst Homan MW, Spuls PI, de Korte J, Bos JD, Sprangers MA, van der Veen JP. The burden of vitiligo: patient characteristics associated with quality of life. J Am Acad Dermatol. 2009 Sep;61(3):411-20. doi: 10.1016/j.jaad.2009.03.022. Epub 2009 Jul 3.
PubMed 19577331Hamzavi IH, Lim HW, Syed ZU. Ultraviolet-based therapy for vitiligo: what's new? Indian J Dermatol Venereol Leprol. 2012 Jan-Feb;78(1):42-8. doi: 10.4103/0378-6323.90945.
PubMed 22199059Hamzavi I, Jain H, McLean D, Shapiro J, Zeng H, Lui H. Parametric modeling of narrowband UV-B phototherapy for vitiligo using a novel quantitative tool: the Vitiligo Area Scoring Index. Arch Dermatol. 2004 Jun;140(6):677-83. doi: 10.1001/archderm.140.6.677.
PubMed 15210457Scherschun L, Kim JJ, Lim HW. Narrow-band ultraviolet B is a useful and well-tolerated treatment for vitiligo. J Am Acad Dermatol. 2001 Jun;44(6):999-1003. doi: 10.1067/mjd.2001.114752.
PubMed 11369913Pacifico A, Leone G. Photo(chemo)therapy for vitiligo. Photodermatol Photoimmunol Photomed. 2011 Oct;27(5):261-77. doi: 10.1111/j.1600-0781.2011.00606.x.
PubMed 21950634Hexsel CL, Mahmoud BH, Mitchell D, Rivard J, Owen M, Strickland FM, Lim HW, Hamzavi I. A clinical trial and molecular study of photoadaptation in vitiligo. Br J Dermatol. 2009 Mar;160(3):534-9. doi: 10.1111/j.1365-2133.2008.08943.x. Epub 2008 Dec 5.
PubMed 19067714Edwards EK Jr, Horwitz SN, Frost P. Reduction of the erythema response to ultraviolet light by nonsteroidal antiinflammatory agents. Arch Dermatol Res. 1982;272(3-4):263-7. doi: 10.1007/BF00509055.
PubMed 7165335Stern RS, Dodson TB. Ibuprofen in the treatment of UV-B-induced inflammation. Arch Dermatol. 1985 Apr;121(4):508-12.
PubMed 3883908
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combination Non Steroidal Antiinflammatory Drugs and Narrowband UVB Treatment in Non-Photoadapters
- ClinicalTrials.gov ID
- NCT05256147
- Acronym / sponsor ID
- 9744
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty in recruiting study population
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- 24 May 2016 (actual)
- Study completion
- 24 May 2016 (actual)
- First posted
- 25 Feb 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.
Narrow band UVB phototherapy is the mainstay of therapy for vitiligo. However, about 1/3 of patients cannot respond to phototherapy. The objective of this study is to determine if the use of ibuprofen can induce non-photoadapters (patients who cannot tolerate increases in NBUVB past 400 mJ/cm2 after 12 sessions) to convert to photoadapters and tolerate raising NBUVB doses to therapeutic levels
Detailed description
Vitiligo is an acquired disorder of pigmentation. The depigmented regions present as white macules and patches and can occur at any age. The vitiligo patches may be asymptomatic, pruritic or may sunburn. Vitiligo has been shown to significantly impact the quality of life and also has an associated psychological burden. Therefore, treatment of vitiligo is essential. Various treatment modalities such as topical corticosteroids, topical calcineurin inhibitors, systemic steroids, surgery, and phototherapy exist to treat vitiligo. UV based phototherapy includes NBUVB, targeted phototherapy, psoralen and UVA photochemotherapy (1-3).
NBUVB is a proven, effective, and well-accepted treatment as part of the standard of care for vitiligo. NBUVB has a sharp emission peak at 311-313 nm. NBUVB is a relatively safe treatment modality, but can cause phototoxic reactions and tanning. Studies have shown that treatment with NBUVB improves the Vitiligo Area Scoring Index by 42% over a period of 6 months. Approximately half of patients should expect 50% repigmentation by 6 months of 2-3x per week phototherapy (4-6). However, a portion of patients are slow responders requiring up to 72 treatments before notable repigmentation has been achieved.
To complicate matters further, about 1/3 of the patients with vitiligo do not photoadapt, meaning the patient does not exhibit a diminished erythema (redness) to equivalent doses of NBUVB upon future irradiations (7). Photoadaption is the principle behind needing to increase the NBUVB dose for all phototherapy regimens (atopic dermatitis, psoriasis, mycosis fungiodes, vitiligo, etc) and why people are able to tolerate longer solar exposure at the end of summer rather than the beginning. It is thought that the non-photoadapters do not respond to NBUVB as their photoadpative capacity may be genetically predetermined (7).
Repigmentation from NBUVB therapy has shown dramatic improvements in quality of life scores (QOL). Tijoe et. al reported 70% improvement in QOL with long term UVB therapy (8). Therefore, identifying adjunctive therapies that can enable non-photoadapters to safely tolerate therapeutic NBUVB doses can significantly raise their QOL. In addition, these therapies can be expanded into the treatment of photoadapters receiving NBUVB to permit higher dose escalations and fewer phototherapy sessions to achieve a therapeutic NBUVB vitiligo dose. This can in-turn potentially decrease health care costs for increased treatments. Also, the patient may experience fewer long-term side effect associated with NBUVB since they may need fewer sessions of NBUVB.
A possible way for non-photoadapters to tolerate NBUVB may be with the use of NSAIDs. Studies performed have shown that the use of NSAIDs showed increased minimal erythema dose by possibly suppressing the immune response by inhibiting cyclooxygenase and prostaglandins (9). Ibuprofen has also shown to decrease inflammation induced by UVB phototherapy (10). Thus, ibuprofen may increase the MED in non-photoadapters.
Therefore, the goal of this study is to see if the use of ibuprofen, an NSAID, will allow for nonphotoadpaters to respond to NBUVB treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: IbuprofenThere is one group in this study and they will receive ibuprofen 400 mg before their narrow band UVB phototherapy session which occurs two to three times weekly. The treatment dose of NBUVB will start off at 150 mJ/cm2 and will be increased 10% as tolerated til the patient reaches 700 mJ/cm2. They will receive ibuprofen before each phototherapy session. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients should have a diagnosis of vitiligo.
- Patients who are identified as nonphotoadapters (those who cannot increase NBUVB dose past 400 mJ/cm2) will be recruited for the study
Key exclusion criteria (1 listed)
- Patients with the daily ibuprofen use, history of renal disease, cardiac disease, gastric uler and bleeding disorder will be excluded from the study. Patients with a history of lupus erythematosus and other photosensitivity disorders will be excluded from the study.
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 |
|---|---|---|
| IbuprofenPatient will receive ibuprofen 400 mg before the phototherapy session. | Drug | Intervention group |
Primary outcome
Vitiligo Area Scoring Index (VASI)
Time frame: 4 months
Investigator will assess surface area of vitiligo using VASI
Results and safety
The study was stopped early (reason given: difficulty in recruiting study population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Background: PubMed 21839315Alikhan A, Felsten LM, Daly M, Petronic-Rosic V. Vitiligo: a comprehensive overview Part I. Introduction, epidemiology, quality of life, diagnosis, differential diagnosis, associations, histopathology, etiology, and work-up. J Am Acad Dermatol. 2011 Sep;65(3):473-491. doi: 10.1016/j.jaad.2010.11.061.
- Background: PubMed 19577331Linthorst Homan MW, Spuls PI, de Korte J, Bos JD, Sprangers MA, van der Veen JP. The burden of vitiligo: patient characteristics associated with quality of life. J Am Acad Dermatol. 2009 Sep;61(3):411-20. doi: 10.1016/j.jaad.2009.03.022. Epub 2009 Jul 3.
- Background: PubMed 22199059Hamzavi IH, Lim HW, Syed ZU. Ultraviolet-based therapy for vitiligo: what's new? Indian J Dermatol Venereol Leprol. 2012 Jan-Feb;78(1):42-8. doi: 10.4103/0378-6323.90945.
- Background: PubMed 15210457Hamzavi I, Jain H, McLean D, Shapiro J, Zeng H, Lui H. Parametric modeling of narrowband UV-B phototherapy for vitiligo using a novel quantitative tool: the Vitiligo Area Scoring Index. Arch Dermatol. 2004 Jun;140(6):677-83. doi: 10.1001/archderm.140.6.677.
- Background: PubMed 11369913Scherschun L, Kim JJ, Lim HW. Narrow-band ultraviolet B is a useful and well-tolerated treatment for vitiligo. J Am Acad Dermatol. 2001 Jun;44(6):999-1003. doi: 10.1067/mjd.2001.114752.
- Background: PubMed 21950634Pacifico A, Leone G. Photo(chemo)therapy for vitiligo. Photodermatol Photoimmunol Photomed. 2011 Oct;27(5):261-77. doi: 10.1111/j.1600-0781.2011.00606.x.
- Background: PubMed 19067714Hexsel CL, Mahmoud BH, Mitchell D, Rivard J, Owen M, Strickland FM, Lim HW, Hamzavi I. A clinical trial and molecular study of photoadaptation in vitiligo. Br J Dermatol. 2009 Mar;160(3):534-9. doi: 10.1111/j.1365-2133.2008.08943.x. Epub 2008 Dec 5.
- Background: PubMed 7165335Edwards EK Jr, Horwitz SN, Frost P. Reduction of the erythema response to ultraviolet light by nonsteroidal antiinflammatory agents. Arch Dermatol Res. 1982;272(3-4):263-7. doi: 10.1007/BF00509055.
- Background: PubMed 3883908Stern RS, Dodson TB. Ibuprofen in the treatment of UV-B-induced inflammation. Arch Dermatol. 1985 Apr;121(4):508-12.
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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 study testing Ibuprofen in people with Vitiligo, run by Henry Ford Health System at 1 site in United States.
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 2 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: stopped early, as of the sponsor's last update on 25 Feb 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 United States. 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 was stopped early (reason given: difficulty in recruiting study population). Results are not available in the source record.
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?
Vitiligo Area Scoring Index (VASI) (time frame: 4 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 NCT05256147, which also lists 9 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 25 Feb 2022.