| Trial name or title |
5‐Aminolevulinic acid photodynamic therapy for the treatment of pre‐malignant disorders of the vulva (uVIN and lichen sclerosis (LS)) |
| Methods |
Parallel‐arm, open‐label RCT |
| Participants |
Included if:
willing to use a medically acceptable method of contraception throughout the study; age 18 and above; histologically proven uVIN, without invasion, or histologically proven LS.
Excluded if:
(micro) invasive carcinoma; pregnancy or lactation; past history of vulval cancer; non HPV‐related VIN; other treatment of VIN, anogenital warts or LS within 1 month of start of treatment; hypersensitivity to any components of the cream formulation; history of psoriasis or other inflammatory dermatosis of the vulva; insufficient understanding of the Dutch language.
|
| Interventions |
Arm 1: low‐dose light fractionated 5‐aminolevulinic acid (gel) and photodynamic therapy (ALA‐PDT)
Arm 2: imiquimod (5% cream) |
| Outcomes |
Primary: clinical response to the treatment in VIN or LS lesions after the end of ALA‐PDT treatment measured by:
reduction in lesion size after the end of treatment as visualised with high resolution photographs; histological regression of uVIN or LS to 'normal' vulval tissue as visualised in H/E stained sections; relief of symptoms like itching and disorder‐related pain.
Secondary (assessed at 4 weeks post‐treatment):
normalisation of immunocompetent cell numbers in the region of the disorder; clearance of HPV DNA in uVIN lesions; normalisation of expression levels of Ki67, p16 and p53; normalisation of expression level of mir‐155; QoL; pain related to treatment.
|
| Starting date |
— |
| Contact information |
l.blok@erasmusmc.nl |
| Notes |
Emailed 9 February 2015 for more details (none received) |
