Trial · NCT02239679

Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy

NCT02239679, Phase 2, Completed, DUSA Pharmaceuticals, Inc.; results first posted 2017-09-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy. Trials, record NCT02239679. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02239679

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy
NCT number: NCT02239679
Status: Completed
Phases: Phase 2
Enrollment: 166 participants, actual
Lead sponsor: DUSA Pharmaceuticals, Inc.
Conditions: Actinic Keratosis
Interventions: Aminolevulinic Acid, Topical Solution Vehicle, BLU-U, Cryotherapy
First posted: 2014-09-15
Last updated: 2018-08-24
Results first posted: 2017-09-21

Source ClinicalTrials.gov

Registered outcomes69

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Total Number of AKs in Treatment Area	Week 52	Count of observed lesions in the treatment area, which include lesions that recurred after on-study cryotherapy as well as newly occurring lesions. AK lesions in the treatment area at baseline (maximum of 2) were excluded for this endpoint.
Secondary	Proportion of Subjects With 0 AKs	Week 4	Normalized based on number of lesions present at Baseline
Secondary	Subject Satisfaction Score	Week 52	Subject satisfaction score 1. = Excellent (very satisfied) 2. = Good (moderately satisfied) 3. = Fair (slightly satisfied) 4. = Poor (not satisfied at all) Unknown
Secondary	Proportion of Subjects With 0 AKs	Week 12	Normalized based on number of lesions present at Baseline
Secondary	Proportion of Subjects With 0 AKs	Week 24	Normalized based on number of lesions present at Baseline
Secondary	Proportion of Subjects With 0 AKs	Week 36	Normalized based on number of lesions present at Baseline
Secondary	Proportion of Subjects With 0 AKs	Week 52	Normalized based on number of lesions present at Baseline
Secondary	Recurrence Rate	Week 52	Recurrence rate of all lesions that were complete responses following on-study cryotherapy (at Visit 3/Baseline).
Secondary	Duration of Response	within 52 weeks after Baseline	Duration of response is the elapsed number of weeks from the Baseline visit until a lesion recurred or Week 52, whichever comes first
Other	Hyperpigmentation	Screening	HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas

1 to 10 of 69Source ClinicalTrials.gov

See all 69 registered outcomes

Outcomes69

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Total Number of AKs in Treatment Area	Week 52	Analysis population consisted of observed data; ie. subjects remaining on-study at Week 52.	lesions	LEAST_SQUARES_MEAN
SECONDARY	Proportion of Subjects With 0 AKs	Week 4	Analysis population consisted of observed data; ie. subjects with data at Week 4.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Subject Satisfaction Score	Week 52		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Subjects With 0 AKs	Week 12	Analysis population consisted of observed data; ie. subjects with data at Week 12.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Subjects With 0 AKs	Week 24	Analysis population consisted of observed data only.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Subjects With 0 AKs	Week 36	Analysis population consisted of observed data only	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Subjects With 0 AKs	Week 52	Analysis population consisted of observed data only	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Recurrence Rate	Week 52	Analysis population consisted of observed data only	number of lesions	COUNT_OF_UNITS
SECONDARY	Duration of Response	within 52 weeks after Baseline	Subjects who discontinued prior to Week 52 were excluded; analysis used observed data only.	weeks	MEAN
OTHER_PRE_SPECIFIED	Hyperpigmentation	Screening		Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 69Source ClinicalTrials.gov

See all 69 outcomes

Results by group915

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Total Number of AKs in Treatment Area	ALA X2		3.0	Standard Error 0.91	lesions
Total Number of AKs in Treatment Area	ALA X3		2.1	Standard Error 0.84	lesions
Total Number of AKs in Treatment Area	VEH-PDT		4.7	Standard Error 0.86	lesions
Proportion of Subjects With 0 AKs	ALA X2		35		Participants
Proportion of Subjects With 0 AKs	ALA X3		35		Participants
Proportion of Subjects With 0 AKs	VEH-PDT		27		Participants
Subject Satisfaction Score	ALA X2	Very Satisfied	27		Participants
Subject Satisfaction Score	ALA X3	Very Satisfied	26		Participants
Subject Satisfaction Score	VEH-PDT	Very Satisfied	16		Participants
Subject Satisfaction Score	ALA X2	Moderately Satisfied	15		Participants

1 to 10 of 915Source ClinicalTrials.gov

See all 915 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	ALA X2	53
Overall Study	STARTED	ALA X3	59
Overall Study	STARTED	VEH-PDT	54
Overall Study	COMPLETED	ALA X2	50
Overall Study	COMPLETED	ALA X3	56
Overall Study	COMPLETED	VEH-PDT	53
Overall Study	NOT COMPLETED	ALA X2	3
Overall Study	NOT COMPLETED	ALA X3	3
Overall Study	NOT COMPLETED	VEH-PDT	1

Source ClinicalTrials.gov

Adverse events39

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	procedural pain	Injury, poisoning and procedural complications	ALA X2	0	53
other	procedural pain	Injury, poisoning and procedural complications	ALA X3	1	59
other	procedural pain	Injury, poisoning and procedural complications	VEH-PDT	3	54
other	back pain	Musculoskeletal and connective tissue disorders	ALA X2	0	53
other	back pain	Musculoskeletal and connective tissue disorders	ALA X3	0	59
other	back pain	Musculoskeletal and connective tissue disorders	VEH-PDT	3	54
other	basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	ALA X2	9	53
other	basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	ALA X3	5	59
other	basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	VEH-PDT	4	54
other	squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	ALA X2	3	53

1 to 10 of 39Source ClinicalTrials.gov

See all 39 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ALA X2	0	53
Total, all-cause mortality	ALA X3	0	59
Total, all-cause mortality	VEH-PDT	0	54
Total, other adverse events	ALA X2	13	53
Total, other adverse events	ALA X3	9	59
Total, other adverse events	VEH-PDT	15	54
Total, serious adverse events	ALA X2	0	53
Total, serious adverse events	ALA X3	3	59
Total, serious adverse events	VEH-PDT	4	54

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38125671	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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