Trial Outcomes & Findings for Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma (NCT NCT00985829)

Results Overview

categorized in 3 groups: complete response: there was no visible or palpable lesion; partial response: there was a visible or palpable lesion but the diameter of the lesion had reduced; no response: there was a visible or palpable lesion and the diameter of the lesion had not reduced

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

28 participants

Primary outcome timeframe

immediately after termination of treatment course (with an average of 5 month after initiation of PDT)

Results posted on

2009-12-22

Participant Flow

all patients with Histologically proven basal cell carcinoma (BCC) entered the study.

Exclusion Criteria: rodent ulcer morphea type positive anti nuclear antibody test history of photosensitivity or photodermatosis or ingestion of phototoxic drugs during last month pregnancy breast feeding age\< 18 history of another therapeutic intervention for bcc during last 6 months

Participant milestones

Participant milestones
Measure	Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) n=28 Participants Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
Age Continuous	59.1 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: immediately after termination of treatment course (with an average of 5 month after initiation of PDT)

categorized in 3 groups: complete response: there was no visible or palpable lesion; partial response: there was a visible or palpable lesion but the diameter of the lesion had reduced; no response: there was a visible or palpable lesion and the diameter of the lesion had not reduced

Outcome measures

Outcome measures
Measure	Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) n=28 Participants Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
Clinical Response to Photodynamic Therapy complete response	9 lesions
Clinical Response to Photodynamic Therapy partial response	14 lesions
Clinical Response to Photodynamic Therapy no response	5 lesions

SECONDARY outcome

Timeframe: immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT)

Population: from those 9 lesions with clinically complete reponse , 3 lesions were biopsied and assessed histologically.

disappearance of the lesion in histologic examination

Outcome measures

Outcome measures
Measure	Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) n=3 Participants Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
Histologic Resolution of Lesion complete resolution in histologic examination	3 lesions
Histologic Resolution of Lesion not complete resolution in histologic examination	0 lesions

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month after termination of treatment course (with an average of 6 months after initiation of PDT)

Population: cosmetic result was assessed among patients with complete response

excellent: no scarring, atrophy, or induration, slight or no redness or change in pigmentation compared to the adjacent skin; good: no scarring, atrophy, or induration, moderate redness or increase in pigmentation compared to the adjacent skin; moderate: slight to moderate scarring, atrophy, or induration; and poor: extensive scarring, atrophy, or induration

Outcome measures

Outcome measures
Measure	Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) n=9 Participants Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
Cosmetic Result excellent	5 lesions
Cosmetic Result good	2 lesions
Cosmetic Result moderate	2 lesions
Cosmetic Result poor	0 lesions

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline

Outcome measures

Outcome measures
Measure	Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) n=28 Participants Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
Location of Lesion scalp	13 lesions
Location of Lesion face	13 lesions
Location of Lesion ear	2 lesions

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline

superficial BCC (sBCC); pigmented BCC(pBCC);nodular BCC (nBCC)

Outcome measures

Outcome measures
Measure	Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) n=28 Participants Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
BCC Type nodular	15 lesions
BCC Type pigmented	7 lesions
BCC Type superficial	6 lesions

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline

past medical history of radiotherapy to the site of tumor before its appearance(for another reason)

Outcome measures

Outcome measures
Measure	Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) n=28 Participants Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
Past Medical History of Radiotherapy positive	17 lesions
Past Medical History of Radiotherapy negative	11 lesions

Adverse Events

Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT) n=28 participants at risk Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
Skin and subcutaneous tissue disorders local intolerable pain	7.1% 2/28 • Number of events 2

Additional Information

Zohreh Tehranchi-nia, assist. prof

skin research center

Phone: +989121029415

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place