VitiligoPhase 3NCT07904910
Evaluation of Crisaborole 2% Versus Tacrolimus 0.1% Each Combined With Excimer Light in the Treatment of Stable Non-segmental Facial Vitiligo: a Prospective Randomized Controlled Study.
A Phase 3 study testing Crisaborole 2% topical ointment, tacrolimus 0.1% and Excimer Light therapy in people with Vitiligo and Non-Segmental Vitiligo (NSV), run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if topical application of crisaborole 2% ointment can treat stable patches of facial vitiligo in pediatrics and adult patients of both genders. It will also learn about the safety of crisaborole 2% ointment. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Vitiligo, Non-Segmental Vitiligo (NSV), Stable Vitiligo
- What is being tested?
- Crisaborole 2% topical ointment, tacrolimus 0.1% and Excimer Light therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2026to 30 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 6 years old.
- Both male and female patients.
- Localized facial vitiligo involving less than 50% of the facial surface area.
- Stable vitiligo defined by fulfillment of both of the following criteria simultaneously at screening:
- Vitiligo Disease Activity (VIDA) score ≤ 0.
- Vitiligo Signs of Activity Score (VSAS) = 0.
- Ability and willingness to comply with treatment and follow-up visits
Who cannot join
- Patients younger than 6 years.
- Segmental vitiligo.
- Vitiligo universalis.
- Pregnancy \& breastfeeding.
- History of transplantation procedure for vitiligo within the past 6 months.
- History of hypersensitivity to the study medication.
Show all 11Show fewer
- History of any skin bleaching treatment for vitiligo or other dermatoses at any point.
- Any contraindication to excimer light therapy e.g., history of skin cancer, photosensitivity disorders.
- Current history of systemic therapy or phototherapy.
- Any topical treatment (such as topical steroids, calcineurin inhibitors, vitamin D analogs, JAK inhibitors, PDE4i) requires a washout period of 2 weeks before screening visit and through the final safety follow-up visit.
- Ultraviolet light exposure, including UVB/UVA/PUVA delivered by booth/excimer laser, or tanning bed exposure, requires a washout period of 8 weeks before screening and through the final safety follow-up visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Cairo University
Cairo
Riham M Mohamed, MD, MSc., PhD, +201066239360, riham.mohye@cu.edu.eg
About this study
The goal of this clinical trial is to learn if topical application of crisaborole 2% ointment can treat stable patches of facial vitiligo in pediatrics and adult patients of both genders. It will also learn about the safety of crisaborole 2% ointment.
The main questions it aims to answer is:
Read more
- Does crisaborole 2% ointment work effectively in stable localized facial vitiligo in pediatrics and adults?
- is crisaborole 2% ointment well tolerated in stable localized facial vitiligo in pediatrics and adults?
- Is crisaborole 2% ointment comparable to tacrolimus 0.1% ointment in terms of efficacy and safety in stable localized facial vitiligo in pediatrics and adults?
Researchers will compare crisaborole 2% ointment to tacrolimus 0.1% ointment to see if crisaborole works as effective and is as well-tolerated.
Participants will:
- apply topical crisaborole 2% ointment or tacrolimus 0.1% ointment twice daily for 6 months (or until complete repigmentation, whichever earlier) to patches of stable facial vitiligo.
- Visit the clinic twice every week for Excimer light sessions, checkups, and photography.
- Keep a diary of their symptoms.
Read the detailed description
The proposed study is a prospective, open-label, assessor-blinded, randomized clinical study that enrolls pediatric and adult patients with stable localized facial vitiligo who are recruited from Kasr Al-Ainy vitiligo Unit, Dermatology outpatient clinic, Dermatology department, Kasr AlAiny hospitals, Cairo University.
The study aims to assess the efficacy, safety and tolerability of crisaborole 2% ointment in the treatment of stable localized facial vitiligo in comparison to tacrolimus 0.1% ointment in pediatrics and adults.
- Conditions
- Vitiligo, Non-Segmental Vitiligo (NSV), Stable Vitiligo
- Being tested
- Crisaborole 2% topical ointment, tacrolimus 0.1%, Excimer Light therapy
- Keywords
- non-segmental vitiligo, facial vitiligo, crisaborole, tacrolimus, excimer light, F-VASI, VESTA, VIS-22
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crisaborole 2% topical ointmentDrug
Participants will be instructed to apply a thin layer of Crisaborole 2% ointment twice daily to the facial vitiligo patches.
tacrolimus 0.1%Drug
Participants will be instructed to apply a thin layer of Tacrolimus 0.1% ointment twice daily to the facial vitiligo patches.
Excimer Light therapyDevice
Also called XECL-308D
Participants will undergo Excimer light sessions twice weekly to the facial vitiligo patches.
| Study group | Role | What they receive |
|---|---|---|
| Crisaborole 2% ointment combined with Excimer light therapy | Experimental | Participants will be instructed to apply a thin layer of Crisaborole 2% ointment twice daily to the facial vitiligo lesions and undergo Excimer light sessions twice weekly for 6 months (or until complete repigmentation, whichever earlier). Receives: Drug: Crisaborole 2% topical ointment; Device: Excimer Light therapy |
| Tacrolimus 0.1% ointment combined with Excimer light therapy | Active comparator | Participants will be instructed to apply a thin layer of Tacrolimus 0.1% ointment twice daily to the facial vitiligo lesions and undergo Excimer light sessions twice weekly for 6 months (or until complete repigmentation, whichever earlier) Receives: Drug: tacrolimus 0.1%; Device: Excimer Light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial Vitiligo Area Scoring Index (F-VASI)
The F-VASI is used specifically to quantify facial vitiligo involvement. The F-VASI score is calculated by multiplying the percentage of affected facial surface area by the degree of depigmentation for each facial site and summing these values across all facial sites. The F-VASI score ranged from 0 to 3, with lower scores indicating greater clinical improvement.
Measured: Upon enrollment, at 12 weeks and at 24 weeks
Vitiligo Extent Score for a Target Area (VESTA)
The score consists of:
- Reference images for marginal repigmentation.
- Reference images for perifollicular repigmentation.
- A formula for calculating total repigmentation percentage. Total repigmentation percentage was defined as the sum of the fully repigmented area and perifollicular repigmentation in the remaining depigmented area.
Measured: At 12 weeks and at 24 weeks
Secondary outcomes (3)
Time to onset of repigmentation
Time to onset of repigmentation is recorded.
Measured: Since enrollment and throughout the treatment period till completion of the study
Vitiligo Impact Scale-22 (VIS-22)
Health-related quality of life is assessed using the Vitiligo Impact Scale-22 (VIS-22), a validated vitiligo-specific questionnaire composed of 22 items evaluating multiple psychosocial domains including anxiety, depression, self-confidence, social interactions, occupation, family relationships, and treatment-related concerns.
The total score ranges from 0 to 66, with higher scores indicating greater impairment in quality of life.
Measured: At 12 weeks and at 24 weeks
Patient Satisfaction
Patient satisfaction was assessed using a standardized five-point Likert scale as follows:
- Very dissatisfied.
- Dissatisfied.
- Neutral.
- Satisfied.
- Very satisfied.
Measured: At 12 weeks and at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start15 May 2026
- Primary completion15 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Cairo 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective assessor-blinded randomized comparative controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riham Mohyeeldeen Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904910
- Sponsor's protocol ID
- MS-378-2025
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paller AS, Tom WL, Lebwohl MG, Blumenthal RL, Boguniewicz M, Call RS, Eichenfield LF, Forsha DW, Rees WC, Simpson EL, Spellman MC, Stein Gold LF, Zaenglein AL, Hughes MH, Zane LT, Hebert AA. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016 Sep;75(3):494-503.e6. doi: 10.1016/j.jaad.2016.05.046. Epub 2016 Jul 11.
PubMed 27417017Pourang A, Kohli I, Ezekwe N, Parks-Miller A, Mohammad TF, Huggins RH, Lim HW, Deal LS, Lukic T, Zhang F, Hamzavi I. Reliability of the Vitiligo Area Scoring Index measurement tool for vitiligo. JAAD Int. 2023 Jun 27;16:206-213. doi: 10.1016/j.jdin.2023.06.008. eCollection 2024 Sep.
PubMed 39040843Sarkar R, Dogra S, Vinay K, Sinha S, Narayan VR, Kumaran MS, Podder I, Jagadeesan S, Bhalla M, Das A, Lakhani R, Sharma R, Barua S, Somani VK, Thappa DM, Mysore V, Swarnkar B. Topical Tacrolimus in Vitiligo: Consensus Paper from the Pigmentary Disorders Society. Clin Cosmet Investig Dermatol. 2024 Dec 17;17:2875-2886. doi: 10.2147/CCID.S455602. eCollection 2024.
PubMed 39717835Seneschal J, Duplaine A, Maillard H, Passeron T, Andreu N, Lassalle R, Favary C, Droitcourt C, Taieb A, Ezzedine K. Efficacy and Safety of Tacrolimus 0.1% for the Treatment of Facial Vitiligo: A Multicenter Randomized, Double-Blinded, Vehicle-Controlled Study. J Invest Dermatol. 2021 Jul;141(7):1728-1734. doi: 10.1016/j.jid.2020.12.028. Epub 2021 Feb 4.
PubMed 33549606Passeron T, Ostovari N, Zakaria W, Fontas E, Larrouy JC, Lacour JP, Ortonne JP. Topical tacrolimus and the 308-nm excimer laser: a synergistic combination for the treatment of vitiligo. Arch Dermatol. 2004 Sep;140(9):1065-9. doi: 10.1001/archderm.140.9.1065.
PubMed 15381545Park OJ, Park GH, Choi JR, Jung HJ, Oh ES, Choi JH, Lee MW, Chang SE. A combination of excimer laser treatment and topical tacrolimus is more effective in treating vitiligo than either therapy alone for the initial 6 months, but not thereafter. Clin Exp Dermatol. 2016 Apr;41(3):236-41. doi: 10.1111/ced.12742. Epub 2015 Aug 24.
PubMed 26299799Zebda R, Paller AS. Phosphodiesterase 4 inhibitors. J Am Acad Dermatol. 2018 Mar;78(3 Suppl 1):S43-S52. doi: 10.1016/j.jaad.2017.11.056. Epub 2017 Dec 15.
PubMed 29248522Sun X, Sheng A, Xu AE. Successful treatment of vitiligo with crisaborole ointment: a report of two cases. Br J Dermatol. 2023 Feb 22;188(3):436-437. doi: 10.1093/bjd/ljac092. No abstract available.
PubMed 36680308Khemis A, Fontas E, Moulin S, Montaudie H, Lacour JP, Passeron T. Apremilast in Combination with Narrowband UVB in the Treatment of Vitiligo: A 52-Week Monocentric Prospective Randomized Placebo-Controlled Study. J Invest Dermatol. 2020 Aug;140(8):1533-1537.e2. doi: 10.1016/j.jid.2019.11.031. Epub 2020 Jan 29.
PubMed 32004567Ye L, Gao Y, Lu Y. Effectiveness of 308-nm Excimer Light with Pimecrolimus and Crisaborole in Pediatric Vitiligo: A Retrospective Study. Clin Cosmet Investig Dermatol. 2026 Jan 27;19:573444. doi: 10.2147/CCID.S573444. eCollection 2026.
PubMed 41878546Li L, Liang Y, Hong J, Lan L, Xiao H, Xie Z. The effectiveness of topical therapy combined with 308-nm excimer laser on vitiligo compared to excimer laser monotherapy in pediatric patients. Pediatr Dermatol. 2019 Jan;36(1):e53-e55. doi: 10.1111/pde.13726. Epub 2018 Dec 5.
PubMed 30520111Liu Z, Ng WH, Morriss S, Liu ZF, Lin L, Xireaili F, Chew C. Excimer 308-Nm Light in the Combination Treatment of Vitiligo: A Systematic Review and Network Meta-Analysis. Pigment Cell Melanoma Res. 2026 Jan;39(1):e70065. doi: 10.1111/pcmr.70065.
PubMed 41564112Goldstein NB, Berk ZBK, Tomb LC, Hu J, Hoaglin LG, Roop DR, Adiri R, Zhuang Y, Canosa JM, Sanders P, Norris DA, Nocka K, Cha A, Birlea SA. Phosphodiesterase-4 Inhibitors Increase Pigment Cell Proliferation and Melanization in Cultured Melanocytes and within a 3-Dimensional Skin Equivalent Model. J Invest Dermatol. 2025 Apr;145(4):883-896. doi: 10.1016/j.jid.2024.08.005. Epub 2024 Sep 7.
PubMed 39182565Bang J, Zippin JH. Cyclic adenosine monophosphate (cAMP) signaling in melanocyte pigmentation and melanomagenesis. Pigment Cell Melanoma Res. 2021 Jan;34(1):28-43. doi: 10.1111/pcmr.12920. Epub 2020 Aug 29.
PubMed 32777162
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Crisaborole 2% Versus Tacrolimus 0.1% Each Combined With Excimer Light in the Treatment of Stable Non-segmental Facial Vitiligo: a Prospective Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT07904910
- Acronym / sponsor ID
- MS-378-2025
- Conditions
- Vitiligo, Non-Segmental Vitiligo (NSV), Stable Vitiligo
- Keywords
- non-segmental vitiligo, facial vitiligo, crisaborole, tacrolimus, excimer light, F-VASI, VESTA, VIS-22
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 29 Oct 2026 (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 goal of this clinical trial is to learn if topical application of crisaborole 2% ointment can treat stable patches of facial vitiligo in pediatrics and adult patients of both genders. It will also learn about the safety of crisaborole 2% ointment.
The main questions it aims to answer is:
- Does crisaborole 2% ointment work effectively in stable localized facial vitiligo in pediatrics and adults?
- is crisaborole 2% ointment well tolerated in stable localized facial vitiligo in pediatrics and adults?
- Is crisaborole 2% ointment comparable to tacrolimus 0.1% ointment in terms of efficacy and safety in stable localized facial vitiligo in pediatrics and adults?
Researchers will compare crisaborole 2% ointment to tacrolimus 0.1% ointment to see if crisaborole works as effective and is as well-tolerated.
Participants will:
- apply topical crisaborole 2% ointment or tacrolimus 0.1% ointment twice daily for 6 months (or until complete repigmentation, whichever earlier) to patches of stable facial vitiligo.
- Visit the clinic twice every week for Excimer light sessions, checkups, and photography.
- Keep a diary of their symptoms.
Detailed description
The proposed study is a prospective, open-label, assessor-blinded, randomized clinical study that enrolls pediatric and adult patients with stable localized facial vitiligo who are recruited from Kasr Al-Ainy vitiligo Unit, Dermatology outpatient clinic, Dermatology department, Kasr AlAiny hospitals, Cairo University.
The study aims to assess the efficacy, safety and tolerability of crisaborole 2% ointment in the treatment of stable localized facial vitiligo in comparison to tacrolimus 0.1% ointment in pediatrics and adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective assessor-blinded randomized comparative controlled study
| Arm | Type | Receives |
|---|---|---|
| Crisaborole 2% ointment combined with Excimer light therapy | Experimental | Drug: Crisaborole 2% topical ointment, Device: Excimer Light therapyParticipants will be instructed to apply a thin layer of Crisaborole 2% ointment twice daily to the facial vitiligo lesions and undergo Excimer light sessions twice weekly for 6 months (or until complete repigmentation, whichever earlier). |
| Tacrolimus 0.1% ointment combined with Excimer light therapy | Active comparator | Drug: tacrolimus 0.1%, Device: Excimer Light therapyParticipants will be instructed to apply a thin layer of Tacrolimus 0.1% ointment twice daily to the facial vitiligo lesions and undergo Excimer light sessions twice weekly for 6 months (or until complete repigmentation, whichever earlier) |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 6 years old.
- Both male and female patients.
- Localized facial vitiligo involving less than 50% of the facial surface area.
- Stable vitiligo defined by fulfillment of both of the following criteria simultaneously at screening:
- Ability and willingness to comply with treatment and follow-up visits
Key exclusion criteria (11 listed)
- Patients younger than 6 years.
- Segmental vitiligo.
- Vitiligo universalis.
- Pregnancy \& breastfeeding.
- History of transplantation procedure for vitiligo within the past 6 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 |
|---|---|---|
| Crisaborole 2% topical ointmentParticipants will be instructed to apply a thin layer of Crisaborole 2% ointment twice daily to the facial vitiligo patches. | Drug | Crisaborole 2% ointment combined with Excimer light therapy |
| tacrolimus 0.1%Participants will be instructed to apply a thin layer of Tacrolimus 0.1% ointment twice daily to the facial vitiligo patches. | Drug | Tacrolimus 0.1% ointment combined with Excimer light therapy |
| Excimer Light therapyAlso: XECL-308DParticipants will undergo Excimer light sessions twice weekly to the facial vitiligo patches. | Device | Crisaborole 2% ointment combined with Excimer light therapy, Tacrolimus 0.1% ointment combined with Excimer light therapy |
Primary outcome
Facial Vitiligo Area Scoring Index (F-VASI)
Time frame: Upon enrollment, at 12 weeks and at 24 weeks
The F-VASI is used specifically to quantify facial vitiligo involvement. The F-VASI score is calculated by multiplying the percentage of affected facial surface area by the degree of depigmentation for each facial site and summing these values across all facial sites. The F-VASI score ranged from 0 to 3, with lower scores indicating greater clinical improvement.
Vitiligo Extent Score for a Target Area (VESTA)
Time frame: At 12 weeks and at 24 weeks
The score consists of: 1. Reference images for marginal repigmentation. 2. Reference images for perifollicular repigmentation. 3. A formula for calculating total repigmentation percentage. Total repigmentation percentage was defined as the sum of the fully repigmented area and perifollicular repigmentation in the remaining depigmented area.
3 secondary outcomes
Time to onset of repigmentation
Time frame: Since enrollment and throughout the treatment period till completion of the study
Vitiligo Impact Scale-22 (VIS-22)
Time frame: At 12 weeks and at 24 weeks
Patient Satisfaction
Time frame: At 12 weeks and at 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 27417017Paller AS, Tom WL, Lebwohl MG, Blumenthal RL, Boguniewicz M, Call RS, Eichenfield LF, Forsha DW, Rees WC, Simpson EL, Spellman MC, Stein Gold LF, Zaenglein AL, Hughes MH, Zane LT, Hebert AA. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016 Sep;75(3):494-503.e6. doi: 10.1016/j.jaad.2016.05.046. Epub 2016 Jul 11.
- Background: PubMed 39040843Pourang A, Kohli I, Ezekwe N, Parks-Miller A, Mohammad TF, Huggins RH, Lim HW, Deal LS, Lukic T, Zhang F, Hamzavi I. Reliability of the Vitiligo Area Scoring Index measurement tool for vitiligo. JAAD Int. 2023 Jun 27;16:206-213. doi: 10.1016/j.jdin.2023.06.008. eCollection 2024 Sep.
- Background: PubMed 39717835Sarkar R, Dogra S, Vinay K, Sinha S, Narayan VR, Kumaran MS, Podder I, Jagadeesan S, Bhalla M, Das A, Lakhani R, Sharma R, Barua S, Somani VK, Thappa DM, Mysore V, Swarnkar B. Topical Tacrolimus in Vitiligo: Consensus Paper from the Pigmentary Disorders Society. Clin Cosmet Investig Dermatol. 2024 Dec 17;17:2875-2886. doi: 10.2147/CCID.S455602. eCollection 2024.
- Background: PubMed 33549606Seneschal J, Duplaine A, Maillard H, Passeron T, Andreu N, Lassalle R, Favary C, Droitcourt C, Taieb A, Ezzedine K. Efficacy and Safety of Tacrolimus 0.1% for the Treatment of Facial Vitiligo: A Multicenter Randomized, Double-Blinded, Vehicle-Controlled Study. J Invest Dermatol. 2021 Jul;141(7):1728-1734. doi: 10.1016/j.jid.2020.12.028. Epub 2021 Feb 4.
- Background: PubMed 15381545Passeron T, Ostovari N, Zakaria W, Fontas E, Larrouy JC, Lacour JP, Ortonne JP. Topical tacrolimus and the 308-nm excimer laser: a synergistic combination for the treatment of vitiligo. Arch Dermatol. 2004 Sep;140(9):1065-9. doi: 10.1001/archderm.140.9.1065.
- Background: PubMed 26299799Park OJ, Park GH, Choi JR, Jung HJ, Oh ES, Choi JH, Lee MW, Chang SE. A combination of excimer laser treatment and topical tacrolimus is more effective in treating vitiligo than either therapy alone for the initial 6 months, but not thereafter. Clin Exp Dermatol. 2016 Apr;41(3):236-41. doi: 10.1111/ced.12742. Epub 2015 Aug 24.
- Background: PubMed 29248522Zebda R, Paller AS. Phosphodiesterase 4 inhibitors. J Am Acad Dermatol. 2018 Mar;78(3 Suppl 1):S43-S52. doi: 10.1016/j.jaad.2017.11.056. Epub 2017 Dec 15.
- Background: PubMed 36680308Sun X, Sheng A, Xu AE. Successful treatment of vitiligo with crisaborole ointment: a report of two cases. Br J Dermatol. 2023 Feb 22;188(3):436-437. doi: 10.1093/bjd/ljac092. No abstract available.
- Background: PubMed 32004567Khemis A, Fontas E, Moulin S, Montaudie H, Lacour JP, Passeron T. Apremilast in Combination with Narrowband UVB in the Treatment of Vitiligo: A 52-Week Monocentric Prospective Randomized Placebo-Controlled Study. J Invest Dermatol. 2020 Aug;140(8):1533-1537.e2. doi: 10.1016/j.jid.2019.11.031. Epub 2020 Jan 29.
- Background: PubMed 41878546Ye L, Gao Y, Lu Y. Effectiveness of 308-nm Excimer Light with Pimecrolimus and Crisaborole in Pediatric Vitiligo: A Retrospective Study. Clin Cosmet Investig Dermatol. 2026 Jan 27;19:573444. doi: 10.2147/CCID.S573444. eCollection 2026.
- Background: PubMed 30520111Li L, Liang Y, Hong J, Lan L, Xiao H, Xie Z. The effectiveness of topical therapy combined with 308-nm excimer laser on vitiligo compared to excimer laser monotherapy in pediatric patients. Pediatr Dermatol. 2019 Jan;36(1):e53-e55. doi: 10.1111/pde.13726. Epub 2018 Dec 5.
- Background: PubMed 41564112Liu Z, Ng WH, Morriss S, Liu ZF, Lin L, Xireaili F, Chew C. Excimer 308-Nm Light in the Combination Treatment of Vitiligo: A Systematic Review and Network Meta-Analysis. Pigment Cell Melanoma Res. 2026 Jan;39(1):e70065. doi: 10.1111/pcmr.70065.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Crisaborole 2% topical ointment, tacrolimus 0.1% and Excimer Light therapy in people with Vitiligo and Non-Segmental Vitiligo (NSV), run by Cairo University at 1 site in Egypt.
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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Riham M Mohamed, MD, MSc., PhD (+201066239360, riham.mohye@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial Vitiligo Area Scoring Index (F-VASI) (time frame: Upon enrollment, at 12 weeks and at 24 weeks). The study lists 2 primary outcomes in all. 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 NCT07904910, which also lists 14 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 29 Oct 2026.