FindTrial
Sign In

ACT01 in Combination With Comp01-04 in Patients With Actinic Keratosis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02126670
Enrollment
100
Registered
2014-04-30
Start date
2014-04-30
Completion date
2014-09-30
Last updated
2016-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis

Brief summary

The purpose of this study is to determine whether or not ACT01 is effective and tolerable alone or when used in combination with Comp01, Comp02, Comp03 or Comp04 in patients with facial and/or scalp keratosis.

Interventions

DRUGACT01
DRUGComp01
DRUGComp02
DRUGComp03
DRUGComp04

Sponsors

Promius Pharma, LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

1. Presence of actinic keratosis lesions on the face and/or scalp within a 25 cm2 contiguous area containing at least four lesions that are non-hypertrophic and non-hyperkeratotic and not larger than 6 mm in longest diameter. 2. Age 30-85 years, inclusive. 3. Good general health as determined by investigator and supported by medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).

Exclusion criteria

1. Severe, uncontrolled auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, pulmonary or renal disease. 2. Dermatologic conditions if present on the face such as acne, atopic dermatitis, seborrheic dermatitis, eczema, rosacea, or albinism. 3. Application of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA (psoralen plus ultraviolet A) therapy, or 5) UVB therapy to the intended treatment area within 180 days prior to the Baseline Visit. 4. Use of sun lamps or sun tanning beds or booths during the 14 days prior to the Baseline Visit.

Design outcomes

Primary

MeasureTime frameDescription
Treatment Success at End of Study Visitup to Day 57Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions

Secondary

MeasureTime frameDescription
Irritation Scoreup to Day 57Percentage of participants with moderate or severe overall irritation at end of treatment.

Countries

United States

Participant flow

Participants by arm

ArmCount
ACT01 Plus Comp01
ACT01 Cream in combination with Comp01 Cream, once daily, 29 days ACT01 Comp01
25
ACT01 Plus Comp02
ACT01 Cream in combination with Comp02 Cream, once daily, 29 days ACT01 Comp02
24
ACT01 Plus Comp03
ACT01 Cream in combination with Comp03 Cream, once daily, 29 days ACT01 Comp03
25
ACT01 Plus Comp04
ACT01 Cream in combination with Comp04 Cream, once daily, 29 days ACT01 Comp04
24
Total98

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyWithdrawal by Subject1001

Baseline characteristics

CharacteristicACT01 Plus Comp01TotalACT01 Plus Comp04ACT01 Plus Comp03ACT01 Plus Comp02
Age, Continuous64.4 years
STANDARD_DEVIATION 11.08
65.5 years
STANDARD_DEVIATION 9.47
66.9 years
STANDARD_DEVIATION 8.28
66.5 years
STANDARD_DEVIATION 8.94
64.4 years
STANDARD_DEVIATION 9.78
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants97 Participants23 Participants25 Participants24 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants0 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
25 Participants97 Participants24 Participants24 Participants24 Participants
Region of Enrollment
United States
25 participants98 participants24 participants25 participants24 participants
Sex: Female, Male
Female
6 Participants18 Participants2 Participants7 Participants3 Participants
Sex: Female, Male
Male
19 Participants80 Participants22 Participants18 Participants21 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
22 / 2624 / 2420 / 2524 / 25
serious
Total, serious adverse events
0 / 260 / 240 / 251 / 25

Outcome results

Primary

Treatment Success at End of Study Visit

Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions

Time frame: up to Day 57

Population: Per protocol

ArmMeasureValue (NUMBER)
ACT01 Plus Comp01Treatment Success at End of Study Visit66.7 percentage of participants
ACT01 Plus Comp02Treatment Success at End of Study Visit65.2 percentage of participants
ACT01 Plus Comp03Treatment Success at End of Study Visit76.0 percentage of participants
ACT01 Plus Comp04Treatment Success at End of Study Visit66.7 percentage of participants
p-value: 0.799Chi-squared
Secondary

Irritation Score

Percentage of participants with moderate or severe overall irritation at end of treatment.

Time frame: up to Day 57

Population: Overall irritation

ArmMeasureValue (NUMBER)
ACT01 Plus Comp01Irritation Score56.0 percentage of participants
ACT01 Plus Comp02Irritation Score75.0 percentage of participants
ACT01 Plus Comp03Irritation Score52.0 percentage of participants
ACT01 Plus Comp04Irritation Score66.7 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026