Trial Outcomes & Findings for Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT) (NCT NCT01000636)
NCT ID: NCT01000636
Last Updated: 2021-05-26
Results Overview
Percent Change in Lesion Counts at Week 18: Week 18 count minus Baseline count divided by Baseline count multiplied by 100.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
9 participants
Primary outcome timeframe
Baseline and Week 18.
Results posted on
2021-05-26
Participant Flow
9 subjects have been enrolled in one site at United Kingdom. First subject included on: March 11th 2010; Last subject out: October 7th 2011
Participant milestones
| Measure |
Metvix® Photodynamic Therapy (PDT)
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Metvix® Photodynamic Therapy (PDT)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)
Baseline characteristics by cohort
| Measure |
Metvix PDT
n=9 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 8.89 • n=93 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
|
Region of Enrollment
United Kingdom
|
9 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 18.Population: This trial was of exploratory nature, no statistical rationale for sample size exists. Analysis was performed on Intent to treat (ITT) population that consisted of the entire population enrolled and randomized (i.e., assigned a treatment number). Here, "Overall Number of Participants Analyzed" = participants with available data at specified time point.
Percent Change in Lesion Counts at Week 18: Week 18 count minus Baseline count divided by Baseline count multiplied by 100.
Outcome measures
| Measure |
Metvix® Photodynamic Therapy (PDT)
n=8 Participants
|
|---|---|
|
Percent Change From Baseline in Lesion Count at Week 18
|
95.5 percent change
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: Baseline and Month15Population: This trial is of exploratory nature, no statistical rationale for sample size exists. This population consists of the entire population enrolled and randomized (i.e., assigned a treatment number).
Outcome measures
| Measure |
Metvix® Photodynamic Therapy (PDT)
n=9 Participants
|
|---|---|
|
Global Percent Change From Baseline in AK Lesion Count in the Target Field (Including New and Recurrent Lesions) at Month15
|
71 Percent change from baseline
Standard Deviation 41.4
|
Adverse Events
Metvix® Photodynamic Therapy (PDT)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Metvix® Photodynamic Therapy (PDT)
n=9 participants at risk
|
|---|---|
|
Infections and infestations
Urinary Track Infection
|
11.1%
1/9 • Number of events 1 • From Screening visit up to Month 15/early termination visit
Questioning of subjects at each follow up visit
|
Other adverse events
| Measure |
Metvix® Photodynamic Therapy (PDT)
n=9 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
22.2%
2/9 • Number of events 2 • From Screening visit up to Month 15/early termination visit
Questioning of subjects at each follow up visit
|
|
Endocrine disorders
Hyperparathyroidism
|
11.1%
1/9 • Number of events 1 • From Screening visit up to Month 15/early termination visit
Questioning of subjects at each follow up visit
|
|
Eye disorders
Cataract
|
11.1%
1/9 • Number of events 1 • From Screening visit up to Month 15/early termination visit
Questioning of subjects at each follow up visit
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1 • From Screening visit up to Month 15/early termination visit
Questioning of subjects at each follow up visit
|
|
General disorders
Application site pain
|
22.2%
2/9 • Number of events 2 • From Screening visit up to Month 15/early termination visit
Questioning of subjects at each follow up visit
|
|
General disorders
Influenza Like illiness
|
11.1%
1/9 • Number of events 1 • From Screening visit up to Month 15/early termination visit
Questioning of subjects at each follow up visit
|
|
Infections and infestations
Cellulitis
|
11.1%
1/9 • Number of events 1 • From Screening visit up to Month 15/early termination visit
Questioning of subjects at each follow up visit
|
|
Infections and infestations
Gastroenteritis viral
|
11.1%
1/9 • Number of events 1 • From Screening visit up to Month 15/early termination visit
Questioning of subjects at each follow up visit
|
|
Infections and infestations
Lower respiratory tract infection viral
|
11.1%
1/9 • Number of events 1 • From Screening visit up to Month 15/early termination visit
Questioning of subjects at each follow up visit
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
1/9 • Number of events 1 • From Screening visit up to Month 15/early termination visit
Questioning of subjects at each follow up visit
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Number of events 1 • From Screening visit up to Month 15/early termination visit
Questioning of subjects at each follow up visit
|
|
Metabolism and nutrition disorders
Gout
|
11.1%
1/9 • Number of events 1 • From Screening visit up to Month 15/early termination visit
Questioning of subjects at each follow up visit
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
11.1%
1/9 • Number of events 1 • From Screening visit up to Month 15/early termination visit
Questioning of subjects at each follow up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
11.1%
1/9 • Number of events 1 • From Screening visit up to Month 15/early termination visit
Questioning of subjects at each follow up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
22.2%
2/9 • Number of events 3 • From Screening visit up to Month 15/early termination visit
Questioning of subjects at each follow up visit
|
|
Nervous system disorders
Migraine
|
11.1%
1/9 • Number of events 1 • From Screening visit up to Month 15/early termination visit
Questioning of subjects at each follow up visit
|
|
Reproductive system and breast disorders
Erectile dysfuntion
|
11.1%
1/9 • Number of events 1 • From Screening visit up to Month 15/early termination visit
Questioning of subjects at each follow up visit
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
55.6%
5/9 • Number of events 10 • From Screening visit up to Month 15/early termination visit
Questioning of subjects at each follow up visit
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
11.1%
1/9 • Number of events 1 • From Screening visit up to Month 15/early termination visit
Questioning of subjects at each follow up visit
|
Additional Information
Farzaneh SIDOU Clinical Project Manager
Galderma
Phone: 00 33 4 93 95 70 70
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any intent of the investigator to publish or disclose in any way the information requires the sponsor's prior written approval. The investigator shall provide his draft of such publication to sponsor to review and approve at least 2 months prior to the date of intended publication. Sponsor shall have the absolute right to determine whether information may be published by the investigator.
- Publication restrictions are in place
Restriction type: OTHER