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Evaluation of the Formulation of 5-aminolevulinic Acid With Dimethylsulfoxide in Photodynamic Therapy for Treatment of Actinic Keratosis

Phase 3
18 Years
Open (Enrolling)
Actinic Keratosis

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Trial Information

Evaluation of the Formulation of 5-aminolevulinic Acid With Dimethylsulfoxide in Photodynamic Therapy for Treatment of Actinic Keratosis

Actinic keratosis is a skin lesion induced by chronic sun exposure with a significant
prevalence and malignant potential for squamous cell carcinoma, which makes essential its
treatment. Today there are several possible therapies, where cryotherapy is usually applied
in our practice. Photodynamic therapy (PDT)is another method also widespread for keratosis
which involves the administration of a topical precursor drug which produces endogenous
photosensitising substances activated by specific light, selectively destroying the diseased
tissue. This study aims to evaluate the use the drug formulation for photodynamic therapy
5-aminolevulinic acid (5-ALA) associated with dimethyl sulfoxide, comparing its efficacy
with conventional cryotherapy, and also pain and cosmetic results. This project enrolled 137
outpatients from the Department of Cutaneous Oncology of Barretos Cancer Hospital - Pio
XII Foundation, with symmetrical and comparable keratosis in their upper limbs. With the
same patient as controls, side arm and therapy to be used were randomized: cryotherapy or
photodynamic therapy. For cryotherapy was utilized bottles of liquid nitrogen (Cry-ac,
500ml); and for photodynamic therapy was utilized incoherent red light lamp with a total
dosis of 37J/cm² . There was one or two sessions of each therapy , at 0 and 3 months; and
three assessments for evaluation were done at 0, 3 and 6 months of onset. The evaluations
on efficacy were in terms of area regression, and classified as complete response or no
response. Pain was assessed by visual analogue scale, and numerical scale. Cosmesis was
evaluated with the presence or not, objectively, of hyper, hypopigmentation or scar
retraction. Finally, patient's preference regarding utilized therapeutics was noted by the

Inclusion Criteria:

- Patients older than 18 years.

- Patients with actinic keratoses "symmetrical", ie, comparable in the upper limbs (
with the same grade, I, II or III).

- Patients in accordance with informed consent.

Exclusion Criteria:

- Patients with concomitant skin diseases, congenital or acquired (albinism, vitiligo,
xeroderma, Gorlin, etc.)

- Immunosuppression (HIV, transplanted patients, etc.)

- Pregnancy or lactation

- Patients who do not agree with the informed consent initially or during the protocol.

- Presence of pigmented lesions near the keratoses.

- Patients with porphyria.

- Patients who have undergone less than 2 months with some kind of treatment for
keratosis in the upper limbs.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Lesion area (cm2) (change outcome measure)

Outcome Description:

Intervention (PDT or Cryotherapy) were done in each randomized upper limb at 0 months. At 3 months the region was evaluated anf if there was some area of residual lesion it was done again the same intervention one second time in the same upper limb.. At 6 months it was evaluated again and if there was some residual area of lesion, it was considered without response. If it was no area of lesion it was considered complete response. In some cases the lesion could be response completely at 3 months and recurr at 6 months (in this case considered no response).

Outcome Time Frame:

0 months (baseline), 3 months and 6 months

Safety Issue:


Principal Investigator

Catarina Robert, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fundação Pio XII - Hospital de Câncer de Barretos


Brazil: National Committee of Ethics in Research

Study ID:




Start Date:

November 2010

Completion Date:

November 2011

Related Keywords:

  • Actinic Keratosis
  • Actinic keratosis
  • Photodynamic therapy
  • 5-aminolevulinic acid
  • Cryotherapy
  • Keratosis
  • Keratosis, Actinic