Comparative Study Between Topical 5-fluorouracil and Latanoprost in Vitiligo.
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study aims to compare the efficacy of topical 5-fluorouracil versus topical latanoprost
      after skin microneedling in the induction of skin repigmentation in localized stable vitiligo
      patients.
    

Detailed description: 
      Vitiligo is an acquired pigmentary disorder characterized by depigmented macules and patches
      secondary to the loss of functional melanocytes. It is a chronic disease that affects between
      0.1% and 2% of the general population, affecting both sexes and all races.

      Theories regarding loss of melanocytes are based on autoimmune, cytotoxic,
      oxidant-antioxidant and neural mechanisms.

      Therapeutic strategies for vitiligo include nonsurgical and surgical methods. Nonsurgical
      options include topical corticosteroids and topical calcineurin inhibitors. Phototherapy as
      psoralen and ultraviolet A (PUVA) and narrow-band ultraviolet B (NB-UVB).

      Two types of surgical techniques are available: tissue grafts and cellular grafts, within
      between autologous cultured epithelial grafts.

      Microneedling is a method of transdermal drug delivery using a microneedling device applied
      to the skin for creating transport pathways through the stratum corneum, increasing the
      absorption of drugs and decreasing the duration of therapy. In addition, microneedling keeps
      the epidermis partially intact, fastens recovery, and limits the risk of infection and
      scarring. 5-Fluorouracil (5-FU) is a chemotherapeutic agent used in the treatment of many
      malignant tumors and it has been approved for topical use in the treatment of several
      dermatologic disorders. Localized hyperpigmentation occurred as a side effect of 5-FU use in
      cancer treatment attracts the attention toward its application in inducing repigmentation in
      vitiligo patches.

      Latanoprost (LT), a prostaglandin F2 alpha analogue used in the treatment of glaucoma, was
      found to induce skin pigmentation in guinea pigs in addition to its known periocular and
      iridal pigmentation side effect.
    

Intervention name(s): Latanoprost 0.005% Ophthalmic Solution; 5Fluorouracil
Intervention type(s): Drug; Drug
Intervention description(s): The affected area cleaned with betadine surgical solution followed by alcohol 70%.
Local anesthetic, pridocaine cream, applied on the treated area under occlusion for 30 min before the procedure.
Using automated microneedling device (Dr Pen Derma Pen Ultima A6®) , which has a disposable head that personalized for each patient and sterilized after each session.
The derma pen will penetrate the skin with variable depths ranging from 0.25 to 0.5 mm (not more than the depth of the epidermis). It will pass vertically over the vitiligo area in a circular pattern until pinpoint bleeding appears.
The LT solution will be applied immediately to vitiligo patch one drop (contains 1.5 μg of LT) for every 2.5 cm.
This procedure will be repeated every two weeks for six months.; The affected area cleaned with betadine surgical solution followed by alcohol 70%.
Local anesthetic, pridocaine cream, applied on the treated area under occlusion for 30 min before the procedure.
Using automated microneedling device (Dr Pen Derma Pen Ultima A6®) , which has a disposable head that personalized for each patient and sterilized after each session.
The derma pen will penetrate the skin with variable depths ranging from 0.25 to 0.5 mm (not more than the depth of the epidermis). It will pass vertically over the vitiligo area in a circular pattern until pinpoint bleeding appears.
Topical application of 5-fluorouracil 5% solution will be rubbed over the affected area for about 2 minutes. Occlusive dressing for hours.
This procedure will be repeated every two weeks for six months.
Other intervention name(s): Microneedling using Dr Pen Derma Pen Ultima A6®; Microneedling using Dr Pen Derma Pen Ultima A6®
Intervention MeSH terms: Fluorouracil; Ophthalmic Solutions; Latanoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment