Bowen's DiseasePhase 4BOWTIENCT03909646
Surgical Excision Versus Photodynamic Therapy and Topical 5-fluorouracil in Treatment of Bowen's Disease
A Phase 4 study testing Methyl Aminolevulinate (Mal) for Topical Administration, 16.8%, 1 Gram, 5Fluorouracil and Surgical excision in people with Bowen's Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
There is limited quality research on the effectiveness of treatments in Bowen's disease (BD). Patient and lesion characteristics, patient preferences and costs should be considered when choosing therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowen's Disease
- What is being tested?
- Methyl Aminolevulinate (Mal) for Topical Administration, 16.8%, 1 Gram, 5Fluorouracil and Surgical excision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 May 2019to 12 Dec 2024
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years
- Histologically proven primary Bowen's disease
- Lesions ≥ 4mm and ≤ 40mm in diameter
- Fitzpatrick skin type I-IV
- Female in child bearing potential should be using contraceptive measures, during and till 3 months post-treatment
Who cannot join
- Bowen's Disease located at ears, periocular, nail unit or periungual tissue, nose, genital and mucous membranes
- High clinical suspicion of invasive SCC
- Interfering treatment of other (N)MSC in target area
- Not able to self-apply cream on lesions located on the back or other difficult to reach locations
- Pregnancy
- Breastfeeding
Show all 14Show fewer
- Allergy to study drugs
- Genetic skin cancer disorders
- Not understanding Dutch language
- Porphyria
- Not able to give informed consent
- Immuno-compromised status
- Use of systemic retinoid in the past 3 months
- Use of immunosuppressant drugs in the past 3 months and / or at time of treatment (such as oral glucocorticoids, cytostatic, antibodies, drug acting on immunophilins, in-terferon, opioids, TNF binding proteins, MMF, biologic agents). Inhalation corticoster-oids / nasal corticosteroids are permitted.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Excision Versus Photodynamic Therapy and Topical 5-fluorouracil in Treatment of Bowen's Disease: a Multicenter Randomized Controlled Trial
There is limited quality research on the effectiveness of treatments in Bowen's disease (BD). Patient and lesion characteristics, patient preferences and costs should be considered when choosing therapy. Surgical excision (SE), photodynamic therapy (PDT) and 5-fluorouracil (5FU) are mentioned as treatment options in guidelines. However no clear and evidence based recommendations are made in terms of effectiveness.
Objective: The aim of this study is 1) to evaluate the (cost)effectiveness of 5FU and PDT compared to SE in BD and 2) to compare the effectiveness of 5FU with that of PDT. With a better understanding of the (cost)effectiveness of alternative treatment options, the investigators will supply the necessary evidence for national and international guidelines, to achieve more uniformity in treatment of BD.
Read more
Study design: Randomized controlled non-inferiority multicenter trial. Study population: Patients ≥18 years, with a histological proven primary lesion of Bowen's disease, visiting Maastricht University Medical Centre, Catharina hospital Eindhoven, VieCuri MC Venlo or Zuyderland Medical Centre Heerlen.
Intervention: One group undergoes SE with a 5mm safety margin followed by routine histological examination. The other group receives PDT with application of methyl aminolevulinate (MAL) cream followed by two illuminations with a one-week interval. The third group receives 5FU cream, which has to be applied by the patient twice daily for 4 weeks.
Main study parameters/endpoints: The primary outcome is the proportion of patients with sustained clearance at 12 months post-treatment. Secondary outcomes are proportion of patients with clearance at 3 months, the long-term probability of sustained clearance, cost-effectiveness, patient satisfaction, patient preferences, compliance, side effects and cosmetic outcome. Post-treatment, patients will be asked to answer a short questionnaire regarding side effects, experience with the treatment and satisfaction.
Read the detailed description
This is a multicenter randomized controlled non-inferiority trial, conducted in one academic and three non-academic hospitals. A multicenter approach (academic and non-academic centers) increases the generalizability of the study results. The study takes place at the dermatology department of Maastricht University Medical Centre (MUMC+), Catharina hospital Eindhoven, VieCuri Medical Centre Venlo and Zuyderland Medical Centre Heerlen.
A non-inferiority design was chosen because although the noninvasive treatments are expected to be somewhat less effective in terms of remaining free of recurrence, there are other benefits such as higher patient satisfaction, patient preferences and better cosmetic outcome. It should be noted that BD is a noninvasive disease and recurrences can be treated with surgical excision without compromising the patient's health.
After giving permission and signing the informed consent form, eligible patients will be randomly assigned to one of three treatment groups: 1) PDT, 2) 5% 5FU cream, 3) surgical excision. All interventions are part of regular care. For the treatment of BD 5% 5FU cream (Efudix®) has been approved by the European Medicines Agency (EMA).
The coordinating investigator who is not blinded to the randomized treatment will prescribe the 5FU cream or give orders to plan PDT or excision and provide patients with further information. The supervising dermatologist will be blinded to treatment allocation, and will be asked to assess outcome measures such as clearance and cosmetic evaluation. Relevant baseline characteristics will be registered (e.g. prior history of skin cancer, age, gender, use of immunosuppressant medication in history, prior treatments for non-melanoma skin cancer), dermatological description of the lesion, size and localization of the lesion and the histological tumour thickness. The presence of other lesions, besides the target lesion, and their treatment will be recorded
The primary outcome will be the proportion of patients with sustained clearance at 12 months follow-up after the end of treatment. Secondary outcomes will be the proportion of patients with clearance at 3 months, the long-term probability of sustained clearance, cost-effectiveness, patient satisfaction, compliance, side effects and cosmetic outcome.
Residual tumour at 3 months follow-up and recurrent tumour at 12 months follow-up is considered as treatment failure and will be treated with surgery.
- Conditions
- Bowen's Disease
- Being tested
- Methyl Aminolevulinate (Mal) for Topical Administration, 16.8%, 1 Gram, 5Fluorouracil, Surgical excision
- Medical subject headings
- Bowen's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methyl Aminolevulinate (Mal) for Topical Administration, 16.8%, 1 GramDrug
Also called Metvix
A layer of methylaminolevulinc acid 160 mg/g cream (about 1 mm thick) is applied to the lesion, with a clinical margin of 5-10 mm surrounding of normal skin and then covered by an occlusive dressing. After 3 hours the occlusive dressing will be removed and the area is illuminated with Omnilux or Actilite (Galderma). After PDT the treatment site is covered again with the above mentioned occlusive dressings during 48 hours. Treatment is performed by an authorized nurse in the hospital. Two sessions should be administered with an interval of one week between sessions.
5FluorouracilDrug
Also called Efudix
5-FU is applied on the treatment area by the patient in a thin layer twice daily during 4 weeks.
Surgical excisionOther
Local anesthesia with lidocain 1% (1-2ml) will be used before performing standard surgical excision with 5 mm safety margin followed by routine histological examination. The skin will be closed using cutaneous sutures, which will be removed after 1-2 weeks. The surgical excision will take place in the hospital by the treating physician
| Study group | Role | What they receive |
|---|---|---|
| Surgical excision | Active comparator | Standard surgical excision with 5 mm safety margin Receives: Other: Surgical excision |
| Photodynamic therapy | Active comparator | PDT with application of methyl aminolevulinate (MAL) cream followed by two illuminations with a one-week interval Receives: Drug: Methyl Aminolevulinate (Mal) for Topical Administration, 16.8%, 1 Gram |
| 5% 5-Fluorouracil | Active comparator | 5FU cream, which has to be applied by the patient twice daily for 4 weeks. Receives: Drug: 5Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained clearance (no residue, recurrence nor progression)
The main study endpoint is the proportion of patients with sustained clearance (no residue, recurrence nor progression) 12 months post-treatment.
Measured: 12 months post-treatment
Secondary outcomes (1)
the proportion of patients with clearance at 3 months post-treatment, the long-term probability of sustained clearance, cost-effectiveness, patient satisfaction, patient preferences, compliance, side effects and cosmetic outcome.
the proportion of patients with clearance at 3 months post-treatment, the long-term probability of sustained clearance, cost-effectiveness, patient satisfaction, patient preferences, compliance, side effects and cosmetic outcome.
Long-term is defined as at least 3 years post-treatment. All patients will be invited for the long-term follow-up visit at least 3 years after finishing treatment, with the last patient finishing treatment at April 16th 2021.
Measured: 3 months and at least 3 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start27 May 2019
- Primary completion2 Mar 2022
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Bowen's DiseaseStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Klara Mosterd, Professor, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909646
- Sponsor's protocol ID
- 67545
- Acronym
- BOWTIE
- Status last verified
- May 2025
- First submitted
- 8 Apr 2019
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holterhues C, Vries Ed, Louwman MW, Koljenovic S, Nijsten T. Incidence and trends of cutaneous malignancies in the Netherlands, 1989-2005. J Invest Dermatol. 2010 Jul;130(7):1807-12. doi: 10.1038/jid.2010.58. Epub 2010 Mar 25.
PubMed 20336085Arlette JP, Trotter MJ. Squamous cell carcinoma in situ of the skin: history, presentation, biology and treatment. Australas J Dermatol. 2004 Feb;45(1):1-9; quiz 10. doi: 10.1111/j.1440-0960.2004.00025.x.
PubMed 14961900Bowen JT. Centennial paper. May 1912 (J Cutan Dis Syph 1912;30:241-255). Precancerous dermatoses: a study of two cases of chronic atypical epithelial proliferation. By John T. Bowen, M.D., Boston. Arch Dermatol. 1983 Mar;119(3):243-60. No abstract available.
PubMed 6297414Shimizu I, Cruz A, Chang KH, Dufresne RG. Treatment of squamous cell carcinoma in situ: a review. Dermatol Surg. 2011 Oct;37(10):1394-411. doi: 10.1111/j.1524-4725.2011.02088.x. Epub 2011 Jul 18.
PubMed 21767324Kao GF. Carcinoma arising in Bowen's disease. Arch Dermatol. 1986 Oct;122(10):1124-6. No abstract available.
PubMed 3767398PETERKA ES, LYNCH FW, GOLTZ RW. An association between Bowen's disease and internal cancer. Arch Dermatol. 1961 Oct;84:623-9. doi: 10.1001/archderm.1961.01580160087015. No abstract available.
PubMed 14485715Bichakjian CK, Olencki T, Aasi SZ, Alam M, Andersen JS, Berg D, Bowen GM, Cheney RT, Daniels GA, Glass LF, Grekin RC, Grossman K, Higgins SA, Ho AL, Lewis KD, Lydiatt DD, Nehal KS, Nghiem P, Olsen EA, Schmults CD, Sekulic A, Shaha AR, Thorstad WL, Tuli M, Urist MM, Wang TS, Wong SL, Zic JA, Hoffmann KG, Engh A. Basal Cell Skin Cancer, Version 1.2016, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2016 May;14(5):574-97. doi: 10.6004/jnccn.2016.0065.
PubMed 27160235Bath-Hextall FJ, Matin RN, Wilkinson D, Leonardi-Bee J. Interventions for cutaneous Bowen's disease. Cochrane Database Syst Rev. 2013 Jun 24;2013(6):CD007281. doi: 10.1002/14651858.CD007281.pub2.
PubMed 23794286Bonerandi JJ, Beauvillain C, Caquant L, Chassagne JF, Chaussade V, Clavere P, Desouches C, Garnier F, Grolleau JL, Grossin M, Jourdain A, Lemonnier JY, Maillard H, Ortonne N, Rio E, Simon E, Sei JF, Grob JJ, Martin L; French Dermatology Recommendations Association (aRED). Guidelines for the diagnosis and treatment of cutaneous squamous cell carcinoma and precursor lesions. J Eur Acad Dermatol Venereol. 2011 Dec;25 Suppl 5:1-51. doi: 10.1111/j.1468-3083.2011.04296.x. No abstract available.
PubMed 22070399Hansen JP, Drake AL, Walling HW. Bowen's Disease: a four-year retrospective review of epidemiology and treatment at a university center. Dermatol Surg. 2008 Jul;34(7):878-83. doi: 10.1111/j.1524-4725.2008.34172.x.
PubMed 18363722Morley GL, Matthews JH, Verpetinske I, Thom GA. A Comparative Study Examining the Management of Bowen's Disease in the United Kingdom and Australia. Dermatol Res Pract. 2015;2015:421460. doi: 10.1155/2015/421460. Epub 2015 Sep 9.
PubMed 26442118Morton CA, Birnie AJ, Eedy DJ. British Association of Dermatologists' guidelines for the management of squamous cell carcinoma in situ (Bowen's disease) 2014. Br J Dermatol. 2014 Feb;170(2):245-60. doi: 10.1111/bjd.12766. No abstract available.
PubMed 24313974Overmark M, Koskenmies S, Pitkanen S. A Retrospective Study of Treatment of Squamous Cell Carcinoma In situ. Acta Derm Venereol. 2016 Jan;96(1):64-7. doi: 10.2340/00015555-2175.
PubMed 26073523Szeimies RM, Karrer S, Backer H. [Therapeutic options for epithelial skin tumors. Actinic keratoses, Bowen disease, squamous cell carcinoma, and basal cell carcinoma]. Hautarzt. 2005 May;56(5):430-40. doi: 10.1007/s00105-005-0950-5. German.
PubMed 15815888Westers-Attema A, van den Heijkant F, Lohman BG, Nelemans PJ, Winnepenninckx V, Kelleners-Smeets NW, Mosterd K. Bowen's disease: A six-year retrospective study of treatment with emphasis on resection margins. Acta Derm Venereol. 2014 Jul;94(4):431-5. doi: 10.2340/00015555-1771.
PubMed 24337161
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Excision Versus Photodynamic Therapy and Topical 5-fluorouracil in Treatment of Bowen's Disease: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03909646
- Acronym / sponsor ID
- BOWTIE / 67545
- Conditions
- Bowen's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 27 May 2019 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 10 Apr 2019 (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.
There is limited quality research on the effectiveness of treatments in Bowen's disease (BD). Patient and lesion characteristics, patient preferences and costs should be considered when choosing therapy. Surgical excision (SE), photodynamic therapy (PDT) and 5-fluorouracil (5FU) are mentioned as treatment options in guidelines. However no clear and evidence based recommendations are made in terms of effectiveness.
Objective: The aim of this study is 1) to evaluate the (cost)effectiveness of 5FU and PDT compared to SE in BD and 2) to compare the effectiveness of 5FU with that of PDT. With a better understanding of the (cost)effectiveness of alternative treatment options, the investigators will supply the necessary evidence for national and international guidelines, to achieve more uniformity in treatment of BD.
Study design: Randomized controlled non-inferiority multicenter trial. Study population: Patients ≥18 years, with a histological proven primary lesion of Bowen's disease, visiting Maastricht University Medical Centre, Catharina hospital Eindhoven, VieCuri MC Venlo or Zuyderland Medical Centre Heerlen.
Intervention: One group undergoes SE with a 5mm safety margin followed by routine histological examination. The other group receives PDT with application of methyl aminolevulinate (MAL) cream followed by two illuminations with a one-week interval. The third group receives 5FU cream, which has to be applied by the patient twice daily for 4 weeks.
Main study parameters/endpoints: The primary outcome is the proportion of patients with sustained clearance at 12 months post-treatment. Secondary outcomes are proportion of patients with clearance at 3 months, the long-term probability of sustained clearance, cost-effectiveness, patient satisfaction, patient preferences, compliance, side effects and cosmetic outcome. Post-treatment, patients will be asked to answer a short questionnaire regarding side effects, experience with the treatment and satisfaction.
Detailed description
This is a multicenter randomized controlled non-inferiority trial, conducted in one academic and three non-academic hospitals. A multicenter approach (academic and non-academic centers) increases the generalizability of the study results. The study takes place at the dermatology department of Maastricht University Medical Centre (MUMC+), Catharina hospital Eindhoven, VieCuri Medical Centre Venlo and Zuyderland Medical Centre Heerlen.
A non-inferiority design was chosen because although the noninvasive treatments are expected to be somewhat less effective in terms of remaining free of recurrence, there are other benefits such as higher patient satisfaction, patient preferences and better cosmetic outcome. It should be noted that BD is a noninvasive disease and recurrences can be treated with surgical excision without compromising the patient's health.
After giving permission and signing the informed consent form, eligible patients will be randomly assigned to one of three treatment groups: 1) PDT, 2) 5% 5FU cream, 3) surgical excision. All interventions are part of regular care. For the treatment of BD 5% 5FU cream (Efudix®) has been approved by the European Medicines Agency (EMA).
The coordinating investigator who is not blinded to the randomized treatment will prescribe the 5FU cream or give orders to plan PDT or excision and provide patients with further information. The supervising dermatologist will be blinded to treatment allocation, and will be asked to assess outcome measures such as clearance and cosmetic evaluation. Relevant baseline characteristics will be registered (e.g. prior history of skin cancer, age, gender, use of immunosuppressant medication in history, prior treatments for non-melanoma skin cancer), dermatological description of the lesion, size and localization of the lesion and the histological tumour thickness. The presence of other lesions, besides the target lesion, and their treatment will be recorded
The primary outcome will be the proportion of patients with sustained clearance at 12 months follow-up after the end of treatment. Secondary outcomes will be the proportion of patients with clearance at 3 months, the long-term probability of sustained clearance, cost-effectiveness, patient satisfaction, compliance, side effects and cosmetic outcome.
Residual tumour at 3 months follow-up and recurrent tumour at 12 months follow-up is considered as treatment failure and will be treated with surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surgical excision | Active comparator | Other: Surgical excisionStandard surgical excision with 5 mm safety margin |
| Photodynamic therapy | Active comparator | Drug: Methyl Aminolevulinate (Mal) for Topical Administration, 16.8%, 1 GramPDT with application of methyl aminolevulinate (MAL) cream followed by two illuminations with a one-week interval |
| 5% 5-Fluorouracil | Active comparator | Drug: 5Fluorouracil5FU cream, which has to be applied by the patient twice daily for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ≥ 18 years
- Histologically proven primary Bowen's disease
- Lesions ≥ 4mm and ≤ 40mm in diameter
- Fitzpatrick skin type I-IV
- Female in child bearing potential should be using contraceptive measures, during and till 3 months post-treatment
Key exclusion criteria (14 listed)
- Bowen's Disease located at ears, periocular, nail unit or periungual tissue, nose, genital and mucous membranes
- High clinical suspicion of invasive SCC
- Interfering treatment of other (N)MSC in target area
- Not able to self-apply cream on lesions located on the back or other difficult to reach locations
- Pregnancy
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 |
|---|---|---|
| Methyl Aminolevulinate (Mal) for Topical Administration, 16.8%, 1 GramAlso: MetvixA layer of methylaminolevulinc acid 160 mg/g cream (about 1 mm thick) is applied to the lesion, with a clinical margin of 5-10 mm surrounding of normal skin and then covered by an occlusive dressing. After 3 hours the occlusive dressing will be removed and the area is illuminated with Omnilux or Actilite (Galderma). After PDT the treatment site is covered again with the above mentioned occlusive dressings during 48 hours. Treatment is performed by an authorized nurse in the hospital. Two sessions should be administered with an interval of one week between sessions. | Drug | Photodynamic therapy |
| 5FluorouracilAlso: Efudix5-FU is applied on the treatment area by the patient in a thin layer twice daily during 4 weeks. | Drug | 5% 5-Fluorouracil |
| Surgical excisionLocal anesthesia with lidocain 1% (1-2ml) will be used before performing standard surgical excision with 5 mm safety margin followed by routine histological examination. The skin will be closed using cutaneous sutures, which will be removed after 1-2 weeks. The surgical excision will take place in the hospital by the treating physician | Other | Surgical excision |
Primary outcome
Sustained clearance (no residue, recurrence nor progression)
Time frame: 12 months post-treatment
The main study endpoint is the proportion of patients with sustained clearance (no residue, recurrence nor progression) 12 months post-treatment.
1 secondary outcome
the proportion of patients with clearance at 3 months post-treatment, the long-term probability of sustained clearance, cost-effectiveness, patient satisfaction, patient preferences, compliance, side effects and cosmetic outcome.
Time frame: 3 months and at least 3 years post-treatment
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 6 May 2025.
- Background: PubMed 20336085Holterhues C, Vries Ed, Louwman MW, Koljenovic S, Nijsten T. Incidence and trends of cutaneous malignancies in the Netherlands, 1989-2005. J Invest Dermatol. 2010 Jul;130(7):1807-12. doi: 10.1038/jid.2010.58. Epub 2010 Mar 25.
- Background: PubMed 14961900Arlette JP, Trotter MJ. Squamous cell carcinoma in situ of the skin: history, presentation, biology and treatment. Australas J Dermatol. 2004 Feb;45(1):1-9; quiz 10. doi: 10.1111/j.1440-0960.2004.00025.x.
- Background: PubMed 6297414Bowen JT. Centennial paper. May 1912 (J Cutan Dis Syph 1912;30:241-255). Precancerous dermatoses: a study of two cases of chronic atypical epithelial proliferation. By John T. Bowen, M.D., Boston. Arch Dermatol. 1983 Mar;119(3):243-60. No abstract available.
- Background: PubMed 21767324Shimizu I, Cruz A, Chang KH, Dufresne RG. Treatment of squamous cell carcinoma in situ: a review. Dermatol Surg. 2011 Oct;37(10):1394-411. doi: 10.1111/j.1524-4725.2011.02088.x. Epub 2011 Jul 18.
- Background: PubMed 3767398Kao GF. Carcinoma arising in Bowen's disease. Arch Dermatol. 1986 Oct;122(10):1124-6. No abstract available.
- Background: PubMed 14485715PETERKA ES, LYNCH FW, GOLTZ RW. An association between Bowen's disease and internal cancer. Arch Dermatol. 1961 Oct;84:623-9. doi: 10.1001/archderm.1961.01580160087015. No abstract available.
- Background: PubMed 27160235Bichakjian CK, Olencki T, Aasi SZ, Alam M, Andersen JS, Berg D, Bowen GM, Cheney RT, Daniels GA, Glass LF, Grekin RC, Grossman K, Higgins SA, Ho AL, Lewis KD, Lydiatt DD, Nehal KS, Nghiem P, Olsen EA, Schmults CD, Sekulic A, Shaha AR, Thorstad WL, Tuli M, Urist MM, Wang TS, Wong SL, Zic JA, Hoffmann KG, Engh A. Basal Cell Skin Cancer, Version 1.2016, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2016 May;14(5):574-97. doi: 10.6004/jnccn.2016.0065.
- Background: PubMed 23794286Bath-Hextall FJ, Matin RN, Wilkinson D, Leonardi-Bee J. Interventions for cutaneous Bowen's disease. Cochrane Database Syst Rev. 2013 Jun 24;2013(6):CD007281. doi: 10.1002/14651858.CD007281.pub2.
- Background: PubMed 22070399Bonerandi JJ, Beauvillain C, Caquant L, Chassagne JF, Chaussade V, Clavere P, Desouches C, Garnier F, Grolleau JL, Grossin M, Jourdain A, Lemonnier JY, Maillard H, Ortonne N, Rio E, Simon E, Sei JF, Grob JJ, Martin L; French Dermatology Recommendations Association (aRED). Guidelines for the diagnosis and treatment of cutaneous squamous cell carcinoma and precursor lesions. J Eur Acad Dermatol Venereol. 2011 Dec;25 Suppl 5:1-51. doi: 10.1111/j.1468-3083.2011.04296.x. No abstract available.
- Background: PubMed 18363722Hansen JP, Drake AL, Walling HW. Bowen's Disease: a four-year retrospective review of epidemiology and treatment at a university center. Dermatol Surg. 2008 Jul;34(7):878-83. doi: 10.1111/j.1524-4725.2008.34172.x.
- Background: PubMed 26442118Morley GL, Matthews JH, Verpetinske I, Thom GA. A Comparative Study Examining the Management of Bowen's Disease in the United Kingdom and Australia. Dermatol Res Pract. 2015;2015:421460. doi: 10.1155/2015/421460. Epub 2015 Sep 9.
- Background: PubMed 24313974Morton CA, Birnie AJ, Eedy DJ. British Association of Dermatologists' guidelines for the management of squamous cell carcinoma in situ (Bowen's disease) 2014. Br J Dermatol. 2014 Feb;170(2):245-60. doi: 10.1111/bjd.12766. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Bowen's Disease
Not yet recruiting
High Intensity Focused Ultrasound vs. Cryotherapy in the Treatment of Basal Cell Carcinomas and Bowen's Disease in Adults
Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma
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.
Klara Mosterd, Professor principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methyl Aminolevulinate (Mal) for Topical Administration, 16.8%, 1 Gram, 5Fluorouracil and Surgical excision in people with Bowen's Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
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 5 inclusion and 14 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 6 May 2025. 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 Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Sustained clearance (no residue, recurrence nor progression) (time frame: 12 months post-treatment). 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 NCT03909646, which also lists 22 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 6 May 2025.