Trial Outcomes & Findings for Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Patients With Skin Type V or IV With Acne Vulgaris (NCT NCT00673933)

NCT ID: NCT00673933

Last Updated: 2013-07-12

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: 4 weeks after last treatment, 6 weeks after baseline
• Results posted on: 2013-07-12

Participant Flow

Two areas on the back per patient was treated, one area with Visonac and one with vehicle

Participant milestones

Measure	Visonac Cream With PDT and Vehicle and PDT 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
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Visonac Cream With PDT and Vehicle and PDT 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
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Visonac and Vehicle Cream With PDT n=20 Participants Two areas on the back per patient was treated, one area with Visonac (Methyl aminolevulinate) and one with vehicle followed by red light illumination.
Age, Categorical <=18 years	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
Skin type Skin type V	18 participants n=5 Participants
Skin type Skin type VI	2 participants n=5 Participants
Inflammatory lesions Visonac treated area	5.9 lesion n=5 Participants
Inflammatory lesions vehicle treated area	6.0 lesion n=5 Participants
Non inflammatory lesions Visonac treated area	6.5 Lesion n=5 Participants
Non inflammatory lesions vehicle treated area	5.4 Lesion n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks after last treatment, 6 weeks after baseline

Outcome measures

Measure	Visonac Cream With PDT n=20 Participants PDT using MAL cream Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light	Vehicle Cream With PDT n=20 Participants PDT using Placebo cream Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light
Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment	0 participants	0 participants

SECONDARY outcome

Timeframe: Immediately after treatment at baseline

Population: ITT

Patients with mild or moderate erythema after first treatment at baseline.

Outcome measures

Measure	Visonac Cream With PDT n=20 Participants PDT using MAL cream Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light	Vehicle Cream With PDT n=20 Participants PDT using Placebo cream Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light
Erythema Score (Mild and Moderate)Immediately After First PDT	10.5 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 4 weeks after last treatment, 6 weeks after baseline

Population: ITT

Outcome measures

Measure	Visonac Cream With PDT n=20 Participants PDT using MAL cream Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light	Vehicle Cream With PDT n=20 Participants PDT using Placebo cream Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light
Change in Inflammatory Lesion Counts From Baseline	-3.70 lesion count Standard Deviation 2.43	-3.90 lesion count Standard Deviation 2.07

SECONDARY outcome

Timeframe: 4 weeks after last treatment, 6 weeks after baseline

Population: ITT

Outcome measures

Measure	Visonac Cream With PDT n=20 Participants PDT using MAL cream Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light	Vehicle Cream With PDT n=20 Participants PDT using Placebo cream Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light
Change in Noninflammatory Lesion Counts From Baseline	-2.95 lesion count Standard Deviation 4.84	-2.50 lesion count Standard Deviation 2.65

SECONDARY outcome

Timeframe: Immediately after second treatment, 2 weeks after baseline

Population: ITT

Patients with mild or moderate erythema after second treatment.

Outcome measures

Measure	Visonac Cream With PDT n=20 Participants PDT using MAL cream Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light	Vehicle Cream With PDT n=20 Participants PDT using Placebo cream Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light
Erythema Score (Mild and Moderate)Immediately After Second Treatment	11.1 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 1 day after 1st treatment and baseline

Population: ITT

Patients with mild or moderate erythema 1 day after first treatment.

Outcome measures

Measure	Visonac Cream With PDT n=20 Participants PDT using MAL cream Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light	Vehicle Cream With PDT n=20 Participants PDT using Placebo cream Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light
Erythema Score (Mild and Moderate)1 Day After First Treatment	0 percentage of participants	0 percentage of participants

Adverse Events

Visonac Cream With PDT

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Vehicle Cream With PDT

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Visonac Cream With PDT n=20 participants at risk PDT using MAL cream Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light	Vehicle Cream With PDT n=20 participants at risk PDT using Placebo cream Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light
Nervous system disorders Paraesthesia	5.0% 1/20 • Number of events 1	15.0% 3/20 • Number of events 3
Skin and subcutaneous tissue disorders Erythema	20.0% 4/20 • Number of events 5	0.00% 0/20
Skin and subcutaneous tissue disorders Pain of skin	5.0% 1/20 • Number of events 2	0.00% 0/20
Skin and subcutaneous tissue disorders Pruritus nos	25.0% 5/20 • Number of events 5	5.0% 1/20 • Number of events 1
Skin and subcutaneous tissue disorders Skin burning sensation	20.0% 4/20 • Number of events 4	20.0% 4/20 • Number of events 4
Skin and subcutaneous tissue disorders Skin warm	35.0% 7/20 • Number of events 9	25.0% 5/20 • Number of events 5
Vascular disorders Hematoma Nos	5.0% 1/20 • Number of events 1	5.0% 1/20 • Number of events 1

Additional Information

Dr Ashish Bhatia

Dermatology Institute

Phone: 630-942-5040

Email: acbhatia@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60