Ignite Creation Date:
2025-12-18 @ 9:26 AM
Ignite Modification Date:
2025-12-18 @ 9:26 AM
Study NCT ID:
NCT05256147
Status:
None
Last Update Posted:
2022-02-25 00:00:00
First Post:
2017-02-22 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Combination Non Steroidal Antiinflammatory Drugs and Narrowband UVB Treatment in Non-Photoadapters
Sponsor:
None
Organization:
Study Overview
Official Title:
Effect of Combination Non Steroidal Antiinflammatory Drugs and Narrowband UVB Treatment in Non-Photoadapters
Status:
None
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
difficulty in recruiting study population
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: