A Randomized Controlled Trial Comparing The Effectiveness And Safety Of iIntralesional 5 Flourouracil Monotherapy Verses 5 Flourouracil Combined With Cryotherapy; In The Treatment Of Keloid Scars
A Randomized Controlled Trial Comparing The Effectiveness And Safety Of iIntralesional 5 Flourouracil Monotherapy Verses 5 Flourouracil Combined With Cryotherapy; In The Treatment Of Keloid Scars
The goal of this clinical trial is to learn how well intralesional 5 fluorouracil with cryotherapy works to treat keloids as compared to intralesional 5 fluorouracil alone on keloids. It will also learn about the safety of both these treatments. The main questions it aims to answer are:
Participants will be divided into two groups:
For Group A: Cryotherapy will be done at lesion site followed by intralesional 5FU every 3 weekly.
For Group B: Intralesional 5FU will be given at lesion site every 3 weekly. Keloids will be assessed at the start of trial and then after 12 weeks of treatment.
The rationale of this study is to find cost-effective treatment regime of cryotherapy with intralesional 5 fluorouracil for keloids. Investigator aim to compare how effective is the combination of cryotherapy followed by intralesional 5 fluorouracil (5FU) as compared to 5 fluorouracil (5FU) alone in the treatment of keloids.
88 patients with keloids consulting the dermatologist in the hospital OPD will be included in the trial after application of the mentioned inclusion and exclusion criteria. After informed consent, a dermatologist will explain the required details of the procedure to the patients and give them their required treatment plan. Participanys will be randomized into two groups by lottery method. Demographic data like age, gender, location, duration, number of keloids, Fitzpatrick skin type, family history of keloids, keloid symptoms (pain, itching or disfigurement), previous treatments (topical steroids, topical silicone sheet or cream, cryotherapy, surgical excision, intralesional steroids or none) will be recorded along with the baseline photograph and rating of severity score based on DSS score. For Group A, Cryotherapy will be done by a spray mini-cryogun ( Brymill B800 Cry-Ac 3 dispenser) using liquid nitrogen targeted at the lesion from the distance of 1 cm and freeze thaw cycles of 30 seconds will be repeated till the lesion freezes to the level of its contact with skin. With larger lesions 2cm2 area will be targeted in a stepwise manner to ensure homogenous cryotherapy of the entire lesion. Local anaesthesia will be given before the cryotherapy with bupivacaine injection, as it relives pain up to 72 hours. 30 minutes after the cryotherapy session intralesional injection of 5 fluorouracil 50mg/ml 0.75ml mixed with 0.25ml triamcinolone acetonide 10mg/ml for every 2cm2 of keloid using a 30-gauge needle with a 3cc syringe. Not to exceed 150 mg/ml in a single session. The injection will be pushed gently into the lesion to the point of inducing swelling and blanching of lesion. The lesion shall be bandaged for 01 hour after the injection.
Group B will be advised local anaesthesia with bupivacaine followed intralesional injection of 5 fluorouracil 50mg/ml 0.75ml mixed with 0.25ml triamcinolone acetonide 10mg/ml for every 2cm2 of keloid. Not to exceed 150 mg in a single session. Oral pain killer will be prescribed for 3 days usage after injection in both treatment groups. Treatment in both groups will be repeated every 3 weeks for 4 sessions in total. If there will be large necrotic area after the previous session, it will be allowed to heal before the next session.
A blinded independent medical observer will perform clinical assessment at the end of 12 weeks treatment period using the DKS score for all 88 patients.
Participant satisfaction will be checked by Patient Global Impression-improvement scale, which is a seven-point scale used by patient to report the overall improvement in their disease with treatment as 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse and 7: very much worse. Side-effects like severe pain, blistering, infection and eschar formation will be noted in both groups within the 12 weeks treatment period starting from the 1st hour post injection. A blinded dermatologist from our department will keep record of the side-effects.
Inclusion Criteria:
Exclusion Criteria
:• Pregnant women or lactating women