Phase2b: Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis

• Sponsor: Vidac Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03538951
• Collaborator: Therapeutics, Inc. (Industry), PharPoint Research, Inc. (Industry), Medistat Ltd., Israel (Industry)
• Enrollment: 83
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.6
• Patients Per Site Per Month: 12.6

Study Details

Study Description

Brief Summary

This is a Phase 2 clinical study in patients with actinic keratosis involving daily application of 1 of 2 strengths of VDA-1102 topical ointment for approximately 12 weeks (84 days). This study has no placebo and the subjects enrolled in the study will know exactly what they are receiving. The objectives of the study are to evaluate the safety and benefit of these two strengths.

Condition or Disease	Intervention/Treatment	Phase
Actinic Keratosis	Drug: 10% VDA-1102; Drug: 20% VDA-1102	Phase 2

Detailed Description

This Phase 2 clinical trial is a 3-part, open-label, multi-center study involving a non-occluded, daily topical dermal application of 1 of 2 strengths of VDA-1102 ointment for approximately 12 weeks (84 days) to an initial 2 cohorts of subjects. The first 40 eligible subjects will be enrolled into Cohort 1 (Part A). Cohort 1 subjects will be assigned to receive approximately 200 mg of 10% VDA-1102 twice-daily (BID). Once approximately 40 subjects have been enrolled in Cohort 1, Cohort 1 will be closed to enrollment and Cohort 2 (Part B) will be opened for enrollment. Cohort 2 subjects will be assigned to receive approximately 200 mg of 20% VDA-1102 once-daily (QD). Once approximately 40 subjects have been enrolled in Cohort 2, an additional 70 subjects will be randomly assigned to Cohort 1 or Cohort 2 (Part C) in a 1:1 ratio.

To qualify for the study, subjects aged 18 (inclusive) or older must have signed informed consent and met the study enrollment criteria that include having 4-8 actinic keratosis (AK) lesions within an approximate 25 cm2 area on the cheek, forehead, or hairless scalp (the "Treatment Field").

Study Design

• Study Type: Interventional
• Actual Enrollment: 83 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: 3-part, open-label, multi-center study3-part, open-label, multi-center study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 2B Open-Label Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis
• Actual Study Start Date: May 23, 2018
• Actual Primary Completion Date: Dec 10, 2018
• Actual Study Completion Date: Dec 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 10% VDA-1102	Drug: 10% VDA-1102; 200 mg twice-daily for 12 weeks; Other Names: 10% VDA-1102 topical ointment
Experimental: Cohort 2 20% VDA-1102	Drug: 20% VDA-1102; 200 mg once-daily for 12 weeks; Other Names: 20% VDA-1102 topical ointment

Outcome Measures

Primary Outcome Measures

1. Complete Clearance Rate [Week 16]

   Efficacy will be evaluated by the proportion of subjects achieving complete clearance of AK lesions in the treatment field of subjects in each treatment arm

2. Complete Facial Clearance Rate [Week 16]

   Efficacy will be evaluated by the proportion of subjects achieving complete clearance of facial AK lesions in the treatment field of subjects in each treatment arm

Secondary Outcome Measures

1. Partial Clearance [16 weeks]

   Efficacy will be evaluated by the proportion of subjects achieving at least 75% clearance of AK lesions in the selected area of subjects of subjects in each treatment arm

2. Partial Facial Clearance [16 weeks]

   Efficacy will be evaluated by the proportion of subjects achieving at least 75% clearance of facial AK lesions in the selected area of subjects in each treatment arm

3. Lesion Number Reduction [16 weeks]

   Efficacy will be evaluated by the proportion of AK lesion reduction in the treatment field of subjects in each treatment arm

4. Lesion Number Reduction on Face [16 weeks]

   Efficacy will be evaluated by the proportion of AK lesion reduction in the facial treatment fields of subjects in each treatment arm

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 4-8 grade 1 or grade 2 AK lesions in Treatment Field on face or scalp

Exclusion Criteria:

• Subject has no clinically significant findings at Baseline

• Subject is unable to demonstrate adequate precision applying the study drug to the Treatment Field at Baseline

• Subject has in the opinion of the Investigator (a) an unstable medical, psychiatric, social problem

• Subject has at any time been given a diagnosis or treatment associated with immunosuppression

• Subject has received VDA-1102 in the past

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Therapeutics Clinical Research	San Diego	California	United States	92123

Sponsors and Collaborators

• Vidac Pharma
• Therapeutics, Inc.
• PharPoint Research, Inc.
• Medistat Ltd., Israel

Investigators

• Principal Investigator: Mark G Lebwohl, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 30, 2018

More Information

Publications

None provided.

• Responsible Party: Vidac Pharma
• ClinicalTrials.gov Identifier: NCT03538951
• Other Study ID Numbers: VDA-CP-05
• First Posted: May 29, 2018
• Last Update Posted: Aug 23, 2022
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Vidac Pharma: actinic keratosis; efficacy; safety; VDA-1102
• Additional relevant MeSH terms: Keratosis, Actinic; Keratosis

Study Results

Participant Flow

Arm/Group Title	Cohort 1	Cohort 2
Arm/Group Description	10% VDA-1102 10% VDA-1102: 200 mg twice-daily for 12 weeks	20% VDA-1102 20% VDA-1102: 200 mg once-daily for 12 weeks
Period Title: Overall Study
STARTED	41	42
COMPLETED	40	40
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Cohort 1	Cohort 2	Total
Arm/Group Description	10% VDA-1102 10% VDA-1102: 200 mg twice-daily for 12 weeks	20% VDA-1102 20% VDA-1102: 200 mg once-daily for 12 weeks	Total of all reporting groups
Overall Participants	41	42	83
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.5 (7.5)	66.4 (9.2)	66.4 (8.3)
Sex: Female, Male (Count of Participants)
Female	6 14.6%	9 21.4%	15 18.1%
Male	35 85.4%	33 78.6%	68 81.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	41 100%	42 100%	83 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	41 100%	42 100%	83 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Complete Clearance Rate
Description	Efficacy will be evaluated by the proportion of subjects achieving complete clearance of AK lesions in the treatment field of subjects in each treatment arm
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

mITT

Arm/Group Title	Cohort 1	Cohort 2
Arm/Group Description	10% VDA-1102 10% VDA-1102: 200 mg twice-daily for 12 weeks	20% VDA-1102 20% VDA-1102: 200 mg once-daily for 12 weeks
Measure Participants	40	40
Count of Participants [Participants]	7 17.1%	9 21.4%

2. Primary Outcome

Title	Complete Facial Clearance Rate
Description	Efficacy will be evaluated by the proportion of subjects achieving complete clearance of facial AK lesions in the treatment field of subjects in each treatment arm
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

mITT

Arm/Group Title	Cohort 1	Cohort 2
Arm/Group Description	10% VDA-1102 10% VDA-1102: 200 mg twice-daily for 12 weeks	20% VDA-1102 20% VDA-1102: 200 mg once-daily for 12 weeks
Measure Participants	26	29
Count of Participants [Participants]	5 12.2%	8 19%

3. Secondary Outcome

Title	Partial Clearance
Description	Efficacy will be evaluated by the proportion of subjects achieving at least 75% clearance of AK lesions in the selected area of subjects of subjects in each treatment arm
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

mITT

Arm/Group Title	Cohort 1	Cohort 2
Arm/Group Description	10% VDA-1102 10% VDA-1102: 200 mg twice-daily for 12 weeks	20% VDA-1102 20% VDA-1102: 200 mg once-daily for 12 weeks
Measure Participants	40	40
Count of Participants [Participants]	12 29.3%	14 33.3%

4. Secondary Outcome

Title	Partial Facial Clearance
Description	Efficacy will be evaluated by the proportion of subjects achieving at least 75% clearance of facial AK lesions in the selected area of subjects in each treatment arm
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

mITT

Arm/Group Title	Cohort 1	Cohort 2
Arm/Group Description	10% VDA-1102 10% VDA-1102: 200 mg twice-daily for 12 weeks	20% VDA-1102 20% VDA-1102: 200 mg once-daily for 12 weeks
Measure Participants	26	29
Count of Participants [Participants]	8 19.5%	13 31%

5. Secondary Outcome

Title	Lesion Number Reduction
Description	Efficacy will be evaluated by the proportion of AK lesion reduction in the treatment field of subjects in each treatment arm
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

mITT

Arm/Group Title	Cohort 1	Cohort 2
Arm/Group Description	10% VDA-1102 10% VDA-1102: 200 mg twice-daily for 12 weeks	20% VDA-1102 20% VDA-1102: 200 mg once-daily for 12 weeks
Measure Participants	40	40
Mean (Standard Deviation) [percentage of change from baseline]	-46.00 (36.47)	-52.66 (37.31)

6. Secondary Outcome

Title	Lesion Number Reduction on Face
Description	Efficacy will be evaluated by the proportion of AK lesion reduction in the facial treatment fields of subjects in each treatment arm
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

mITT

Arm/Group Title	Cohort 1	Cohort 2
Arm/Group Description	10% VDA-1102 10% VDA-1102: 200 mg twice-daily for 12 weeks	20% VDA-1102 20% VDA-1102: 200 mg once-daily for 12 weeks
Measure Participants	26	29
Mean (Standard Deviation) [Percentage of change from baseline]	-48.51 (37.35)	-62.42 (34.02)

7. Post-Hoc Outcome

Title	Complete Clearance in Patients With Local Skin Reaction- Erythema
Description	Erythema (score=0 or score >0) week 8 100% clearance week 16 (Face and Scalp)
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Data analyzed by patients with erythema score =0 or > 0

Arm/Group Title	Cohort 1	Cohort 2
Arm/Group Description	10% VDA-1102 10% VDA-1102: 200 mg twice-daily for 12 weeks	20% VDA-1102 20% VDA-1102: 200 mg once-daily for 12 weeks
Measure Participants	40	39
Complete clearance	2 4.9%	4 9.5%
No complete clearance	21 51.2%	24 57.1%
Complete clearance	5 12.2%	6 14.3%
No complete clearance	12 29.3%	5 11.9%

8. Post-Hoc Outcome

Title	Lesion Reduction in Patients With Local Skin Reaction- Erythema
Description	Erythema (score=0 or score >0) week 8 75% clearance week 16 (Face and Scalp)
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Data no analyzed for cohort 1 (10% VDA-1102)

Arm/Group Title	Cohort 1	Cohort 2
Arm/Group Description	10% VDA-1102 10% VDA-1102: 200 mg twice-daily for 12 weeks	20% VDA-1102 20% VDA-1102: 200 mg once-daily for 12 weeks
Measure Participants	0	37
75% lesion reduction	0 0%	5 11.9%
Less than 75% lesion reduction	0 0%	23 54.8%
75% lesion reduction	0 0%	6 14.3%
Less than 75% lesion reduction	0 0%	3 7.1%

Adverse Events

Time Frame	From screening until week 16
Arm/Group Title	Cohort 1		Cohort 2
Arm/Group Description	10% VDA-1102 10% VDA-1102: 200 mg twice-daily for 12 weeks		20% VDA-1102 20% VDA-1102: 200 mg once-daily for 12 weeks
All Cause Mortality
	Cohort 1		Cohort 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/42 (0%)
Serious Adverse Events
	Cohort 1		Cohort 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/42 (0%)
Other (Not Including Serious) Adverse Events
	Cohort 1		Cohort 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/41 (24.4%)		10/42 (23.8%)
Skin and subcutaneous tissue disorders
Skin reaction	10/41 (24.4%)	14	10/42 (23.8%)	13

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.