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Trial record 17 of 142 for:    acne AND erythema

Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Patients With Skin Type V or IV With Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT00673933
Recruitment Status : Completed
First Posted : May 7, 2008
Results First Posted : July 12, 2013
Last Update Posted : July 12, 2013
Sponsor:
Information provided by (Responsible Party):
Photocure

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Intervention Drug: Methyl aminolevulinate (MAL) PDT
Enrollment 20
Recruitment Details  
Pre-assignment Details Two areas on the back per patient was treated, one area with Visonac and one with vehicle
Arm/Group Title Visonac Cream With PDT and Vehicle and PDT
Hide Arm/Group Description Two areas on the back per patient was treated, one area with Visonac and one with vehicle. Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light
Period Title: Overall Study
Started 20
Completed 17
Not Completed 3
Reason Not Completed
Withdrawal by Subject             2
Lost to Follow-up             1
Arm/Group Title Visonac and Vehicle Cream With PDT
Hide Arm/Group Description Two areas on the back per patient was treated, one area with Visonac (Methyl aminolevulinate) and one with vehicle followed by red light illumination.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
4
  20.0%
Between 18 and 65 years
16
  80.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
9
  45.0%
Male
11
  55.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
Skin type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
Skin type V 18
Skin type VI 2
[1]
Measure Description: Skin type according to the Fitzpatrick Classification Scale. Skin type V: Brown, dark brown.Very rarely burns, tans very easily Skin type VI: Black, very dark brown to black. Never burns, tans very easily, deeply pigmented
Inflammatory lesions  
Mean (Full Range)
Unit of measure:  Lesion
Number Analyzed 20 participants
Visonac treated area
5.9
(5 to 11)
vehicle treated area
6.0
(5 to 10)
Non inflammatory lesions  
Mean (Full Range)
Unit of measure:  Lesion
Number Analyzed 20 participants
Visonac treated area
6.5
(1 to 21)
vehicle treated area
5.4
(2 to 17)
1.Primary Outcome
Title Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment
Hide Description [Not Specified]
Time Frame 4 weeks after last treatment, 6 weeks after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:

PDT using MAL cream

Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light

PDT using Placebo cream

Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light

Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
0 0
2.Secondary Outcome
Title Erythema Score (Mild and Moderate)Immediately After First PDT
Hide Description Patients with mild or moderate erythema after first treatment at baseline.
Time Frame Immediately after treatment at baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:

PDT using MAL cream

Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light

PDT using Placebo cream

Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light

Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: percentage of participants
10.5 0.0
3.Secondary Outcome
Title Change in Inflammatory Lesion Counts From Baseline
Hide Description [Not Specified]
Time Frame 4 weeks after last treatment, 6 weeks after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:

PDT using MAL cream

Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light

PDT using Placebo cream

Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: lesion count
-3.70  (2.43) -3.90  (2.07)
4.Secondary Outcome
Title Change in Noninflammatory Lesion Counts From Baseline
Hide Description [Not Specified]
Time Frame 4 weeks after last treatment, 6 weeks after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:

PDT using MAL cream

Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light

PDT using Placebo cream

Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: lesion count
-2.95  (4.84) -2.50  (2.65)
5.Secondary Outcome
Title Erythema Score (Mild and Moderate)Immediately After Second Treatment
Hide Description Patients with mild or moderate erythema after second treatment.
Time Frame Immediately after second treatment, 2 weeks after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:

PDT using MAL cream

Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light

PDT using Placebo cream

Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light

Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: percentage of participants
11.1 0
6.Secondary Outcome
Title Erythema Score (Mild and Moderate)1 Day After First Treatment
Hide Description Patients with mild or moderate erythema 1 day after first treatment.
Time Frame 1 day after 1st treatment and baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description:

PDT using MAL cream

Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light

PDT using Placebo cream

Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light

Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: percentage of participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Visonac Cream With PDT Vehicle Cream With PDT
Hide Arm/Group Description

PDT using MAL cream

Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light

PDT using Placebo cream

Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light

All-Cause Mortality
Visonac Cream With PDT Vehicle Cream With PDT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Visonac Cream With PDT Vehicle Cream With PDT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Visonac Cream With PDT Vehicle Cream With PDT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/20 (60.00%)      12/20 (60.00%)    
Nervous system disorders     
Paraesthesia  1/20 (5.00%)  1 3/20 (15.00%)  3
Skin and subcutaneous tissue disorders     
Erythema  4/20 (20.00%)  5 0/20 (0.00%)  0
Pain of skin  1/20 (5.00%)  2 0/20 (0.00%)  0
Pruritus nos  5/20 (25.00%)  5 1/20 (5.00%)  1
Skin burning sensation  4/20 (20.00%)  4 4/20 (20.00%)  4
Skin warm  7/20 (35.00%)  9 5/20 (25.00%)  5
Vascular disorders     
Hematoma Nos [1]  1/20 (5.00%)  1 1/20 (5.00%)  1
[1]
Non treatment site, included under both Visonac and vehicle arm
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr Ashish Bhatia
Organization: Dermatology Institute
Phone: 630-942-5040
Responsible Party: Photocure
ClinicalTrials.gov Identifier: NCT00673933     History of Changes
Other Study ID Numbers: PC TA203/08
First Submitted: May 5, 2008
First Posted: May 7, 2008
Results First Submitted: February 14, 2013
Results First Posted: July 12, 2013
Last Update Posted: July 12, 2013