## Protocol Section
### Identification Module
**NCT ID:** NCT02451579

**Brief Title:** A Clinical Trial Evaluating the Role of Systemic Antihistamine Therapy in the Reduction of Adverse Effects Associated With Topical 5-aminolevulinic Acid Photodynamic Therapy

**Official Title:** A Randomized, Double-blind, Placebo-controlled, Prospective Clinical Trial Evaluating the Role of Systemic Antihistamine Therapy in the Reduction of Adverse Effects Associated With Topical 5-aminolevulinic Acid Photodynamic Therapy

#### Organization Study ID Info
**ID:** PDT-2015-01
#### Organization
**Class:** OTHER
**Full Name:** Goldman, Butterwick, Fitzpatrick and Groff
### Status Module
#### Completion Date
**Date:** 2017-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-03-01

**Type:** ACTUAL

**Last Update Submit Date:** 2017-02-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-12

**Type:** ACTUAL

#### Start Date
**Date:** 2015-02

**Status Verified Date:** 2017-02

#### Study First Post Date
**Date:** 2015-05-22
**Type:** ESTIMATED
**Study First Submit Date:** 2015-05-12
**Study First Submit QC Date:** 2015-05-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** DUSA Pharmaceuticals, Inc.

#### Lead Sponsor

**Class:** OTHER

**Name:** Goldman, Butterwick, Fitzpatrick and Groff

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** A double-blind, placebo controlled study conducted at a single study site. Evaluating the role of systemic antihistamine therapy in the reduction of adverse effects associated with topical 5-aminolevulinic acid photodynamic therapy.

### Conditions Module

**Conditions:**

- Actinic Keratoses

**Keywords:**

- Actinic Keratoses

- Photodynamic Therapy

- PDT

- Blue Light

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Prophylactic use of cetirizine hydrochloride prior to and after Topical 5-aminolevulinic Acid Photodynamic Therapy

**Intervention Names:**

- Drug: Antihistamine Cetirizine Hydrochloride

**Label:** Cetirizine Hydrochloride

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Prophylactic use of placebo prior to and after Topical 5-aminolevulinic Acid Photodynamic Therapy

**Intervention Names:**

- Other: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cetirizine Hydrochloride

**Description:** Prophylactic use of antihistamine prior to and following topical 5-aminolevulonic acid photodynamic therapy

**Name:** Antihistamine Cetirizine Hydrochloride

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Use of placebo prior to and following topical 5-aminolevulonic acid photodynamic therapy

**Name:** Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Localized Skin Response consisting of erythema, edema, crusting, exudation, Vesiculation/Pustulation and erosion/ ulceration Investigator evaluated on a standardized scale

**Measure:** Localized Skin Response

**Time Frame:** Up to day 180

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age \> 18
* Subjects with 5-20 actinic keratosis of the face
* Patients undergoing photodynamic therapy (PDT) to the face for AK with 5-aminolevulinic acid (ALA) activated by blue light.
* Must be willing to give and sign a HIPPA form, photo consent and informed consent form.
* Must be willing to comply with study dosing and complete the entire course of the study.
* Female patients will be either of non-childbearing potential defined as:

  1. Having no uterus
  2. No menses for at least 12 months.

Or;

(WOCBP) women of childbearing potential must agree to use an effective method of birth control during the course of the study, such as:

1. Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
2. Intrauterine coil
3. Bilateral tubal ligation
4. Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
5. Abstinence (If practicing abstinence must agree to use barrier method described above (d) if becomes sexually active).
6. Vasectomized partner g. Negative urine pregnancy test results Baseline prior to study entry (if applicable)

Exclusion Criteria:

* Presence of incompletely healed wound in treatment area
* Presence of known or suspected BCC or SCC in treatment area
* Previous PDT or treatment of the face with any topical cytotoxic or immunomodulatory agent for AKs within the past 6 months
* Co-existing potentially confounding skin condition within treatment area (e.g. eczema, psoriasis, XP, rosacea) at investigator's discretion
* Presence of tattoo and/or scar in the treatment area that in the investigators opinion would interfere with study assessments
* Subjects with known photosensitivity or taking photosensitizing medications listed below:

  1. Oral diabetes medicines
  2. Griseofulvin
  3. Thiazide diuretics
  4. Sulfonylureas
  5. Phenothiazines
  6. Tetracycline's
  7. St. John's Wort
* Use of oral/topical retinoids within 1 month of Baseline
* Subjects with a history of sensitivity to porphyrins
* Subjects with recently excessive exposure of the treatment area to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study
* Female subjects who are pregnant, nursing an infant or planning a pregnancy during the study \[throughout the course of the study
* Presence or evidence of any conditions that in the opinion of the investigator might impede the subject's ability to give consent or comply with protocol requirements.
* Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study
* History of non-compliance with clinical research protocols
* Ablative laser resurfacing to on their face within 12 months
* Non-ablative laser or light procedures to their face within the past 3 months
* Microdermabrasion (light or medium skin peel) treatment on their face within the past 30 days

**Healthy Volunteers:** True

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** San Diego

**Country:** United States

**Facility:** Cosmetic Laser Dermatology

**State:** California

**Zip:** 92121

#### Overall Officials

**Official 1:**

**Affiliation:** Cosmetic Laser Dermatology

**Name:** Mitchel P Goldman, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Vanaman Wilson MJ, Jones IT, Wu DC, Goldman MP. A randomized, double-blind, placebo-controlled clinical trial evaluating the role of systemic antihistamine therapy for the reduction of adverse effects associated with topical 5-aminolevulinic acid photodynamic therapy. Lasers Surg Med. 2017 Oct;49(8):738-742. doi: 10.1002/lsm.22682. Epub 2017 May 10.

**PMID:** 28489298

## Annotation Section

### Unposted Annotation

#### Event: RELEASE

- Date: 2019-05-01

- Date Unknown: Unknown

#### Event: RESET

- Date: 2019-05-22

- Date Unknown: Unknown

#### Event: RELEASE

- Date: 2019-08-15

- Date Unknown: Unknown

#### Event: RESET

- Date: 2019-09-04

- Date Unknown: Unknown

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012871

- Term: Skin Diseases

- ID: D000011230

- Term: Precancerous Conditions

- ID: D000009369

- Term: Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M28268

- Name: Keratosis, Actinic

- Relevance: HIGH

- As Found: Actinic Keratosis

- ID: M10668

- Name: Keratosis

- Relevance: HIGH

- As Found: Keratosis

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14111

- Name: Precancerous Conditions

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000055623

- Term: Keratosis, Actinic

- ID: D000007642

- Term: Keratosis

### Intervention Browse Module - Ancestors

- ID: D000018926

- Term: Anti-Allergic Agents

- ID: D000039563

- Term: Histamine H1 Antagonists, Non-Sedating

- ID: D000018494

- Term: Histamine Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AAll

- Name: Anti-Allergic Agents

### Intervention Browse Module - Browse Leaves

- ID: M3960

- Name: Aminolevulinic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M9709

- Name: Histamine Antagonists

- Relevance: HIGH

- As Found: Diathermy

- ID: M9710

- Name: Histamine H1 Antagonists

- Relevance: HIGH

- As Found: Diathermy

- ID: M19620

- Name: Cetirizine

- Relevance: HIGH

- As Found: Hearing loss

- ID: M9708

- Name: Histamine

- Relevance: LOW

- As Found: Unknown

- ID: M212144

- Name: Histamine phosphate

- Relevance: LOW

- As Found: Unknown

- ID: M20962

- Name: Anti-Allergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M24826

- Name: Histamine H1 Antagonists, Non-Sedating

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017332

- Term: Cetirizine

- ID: D000006633

- Term: Histamine Antagonists

- ID: D000006634

- Term: Histamine H1 Antagonists

### Misc Info Module

#### Submission Tracking

- Estimated Results First Submit Date: 2019-05-01

##### Submission Infos

- MCP Release N: Unknown

- Release Date: 2019-05-01

- Reset Date: 2019-05-22

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- MCP Release N: Unknown

- Release Date: 2019-08-15

- Reset Date: 2019-09-04

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- Version Holder: 2024-05-24
