Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the face or scalp.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Placebo Comparator |
| |
| 5 | Experimental |
| |
| 6 | Experimental |
| |
| 7 | Experimental |
| |
| 8 | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEP005 Topical Gel | Drug | 0.005%, two days treatment |
| |
| PEP005 Topical Gel |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs Recorded Throughout the Study | Incidence of AEs recorded throughout the study | 57 days |
| Incidence of SAE Recorded Throughout the Study | Incidence of SAE recorded throughout the study | 57 days |
| Incidence Rate and Severity of LSRs Following Study Medication Application | The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit. The actual value and change from baseline in the composite LSR score were also summarized. | Baseline |
| Incidence Rate and Severity of LSRs Following Study Medication Application | The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit. The actual value and change from baseline in the composite LSR score were also summarized. | Day 57 |
| Incidence of Hyperpigmentation Following Study Medication Application | The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. | Baseline |
| Incidence of Hyperpigmentation Following Study Medication Application |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy (Clearance of AK Lesions) Partial Clearance Rate | Partial clearence rate, defined as the number of patients at the Day 57 visit with a 75% or greater reduction in the number of AK lesions identified at baseline, in the Face and Scalp | 57 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
within 8 weeks and 2 cm of treatment area
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arizona | 71913 | United States | ||
| Dermatology Research of Arkansas |
Not provided
| Label | URL |
|---|---|
| Food and Drug Authority | View source |
| Therapeutic Goods Administration | View source |
Not provided
Not provided
First patient randomized: 24 June 2008 Last patient completed Day 57: 20 October 2008
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 1. PEP005 Topical Gel 0.005% | Two days treatment day 1, 2 |
| FG001 | 2. PEP005 Topical Gel 0.01% | Two days treatment, day 1, 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Drug |
0.01%, two days treatment |
|
| PEP005 Topical Gel | Drug | 0.015%, two days treatment |
|
| Vehicle gel | Drug | two days treatment |
|
| PEP005 Topical Gel | Drug | 0.005%, three days treatment |
|
| PEP005 Topical Gel | Drug | 0.01%, three days treatment |
|
| PEP005 Topical Gel | Drug | 0.015%, three days treatment |
|
| Vehicle gel | Drug | three days treatment |
|
The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent) |
| Day 57 |
| Incidence of Hypopigmentation Following Study Medication Application | The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent) | Baseline |
| Incidence of Hypopigmentation Following Study Medication Application | The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent) | Day 57 |
| Incidence of Scarring Following Study Medication Application | The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent) | Baseline |
| Incidence of Scarring Following Study Medication Application | The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent). | Day 57 |
| Complete Clearance Rate of AK Lesions; | Defined as the number of patients at the day 57 post-treatment visit with no clinically visible AK lesions in the selected treatment area | Day 57 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Koppel Dermatology | Los Angeles | California | 70072 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Integrated Research Group Inc | Riverside | California | 92506 | United States |
| Skin Surgery Medical Group Inc | San Diego | California | 92117 | United States |
| 470 Castro St Suite 202-204 | San Francisco | California | 94114 | United States |
| Solano Clinical Research | Vallejo | California | 94589 | United States |
| Dermatology Specialists Inc | Vista | California | 92083 | United States |
| Spencer Derm and Skin Surgery Center | St. Petersburg | Florida | 33716 | United States |
| Northwest Clinical Trial | Boise | Idaho | 83704 | United States |
| Altman Dermatology Associates | Arlington Heights | Illinois | 60005 | United States |
| Christie Clinic | Champaign | Illinois | 61820 | United States |
| South Bend Clinic | South Bend | Indiana | 46617 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| TKL Research, Inc. | Paramus | New Jersey | 07652 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Oregon Medical Research Center | Portland | Oregon | 97223 | United States |
| Philadelphia Institute of Dermatology | Philadelphia | Pennsylvania | 19034 | United States |
| Dermatology Research Associates | Nashville | Tennessee | 37203 | United States |
| DermResearch, Inc. 8140 N. MoPac, Bldg. 3, Suite 120, | Austin | Texas | 78759 | United States |
| Suzanne Bruce and Associates, The Center for Skin Research | Houston | Texas | 77056 | United States |
| Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | 78229 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78229 | United States |
| Dermatology Associates of Tyler | Tyler | Texas | 75703 | United States |
| Southderm Pty Ltd | Kogarah | New South Wales | 2217 | Australia |
| The Skin Centre | Benowa | Queensland | 4217 | Australia |
| Siller Medical | Brisbane | Queensland | 4000 | Australia |
| FG002 | 3. PEP005 Topical Gel 0.015% | Two days treatment day 1, 2 |
| FG003 | 4. Vehicle Gel | Two days treatment, day 1, 2 |
| FG004 | 5. PEP005 Topical Gel 0.005% | Three days treatment, day 1, 2, 3 |
| FG005 | 6. PEP005 Topical Gel 0.01% | Three days treatment, day 1, 2, 3 |
| FG006 | 7. PEP005 Topical Gel 0.015% | Three days treatment, day 1, 2, 3 |
| FG007 | 8. Vehicle Gel | Three days treatment, day 1, 2, 3 |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 1. PEP005 Topical Gel 0.005% | Two days treatment day 1, 2 |
| BG001 | 2. PEP005 Topical Gel 0.01% | Two days treatment, day 1, 2 |
| BG002 | 3. PEP005 Topical Gel 0.015% | Two days treatment day 1, 2 |
| BG003 | 4. Vehicle Gel | Two days treatment, day 1, 2 |
| BG004 | 5. PEP005 Topical Gel 0.005% | Three days treatment, day 1, 2, 3 |
| BG005 | 6. PEP005 Topical Gel 0.01% | Three days treatment, day 1, 2, 3 |
| BG006 | 7. PEP005 Topical Gel 0.015% | Three days treatment, day 1, 2, 3 |
| BG007 | 8. Vehicle Gel | Three days treatment, day 1, 2, 3 |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of AEs Recorded Throughout the Study | Incidence of AEs recorded throughout the study | One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population. | Posted | Number | participants | 57 days |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Efficacy (Clearance of AK Lesions) Partial Clearance Rate | Partial clearence rate, defined as the number of patients at the Day 57 visit with a 75% or greater reduction in the number of AK lesions identified at baseline, in the Face and Scalp | Posted | Number | participants | 57 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Incidence of SAE Recorded Throughout the Study | Incidence of SAE recorded throughout the study | One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population. | Posted | Number | participants | 57 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Incidence Rate and Severity of LSRs Following Study Medication Application | The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit. The actual value and change from baseline in the composite LSR score were also summarized. | One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population. | Posted | Mean | Standard Deviation | scores on a scale | Baseline |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Incidence Rate and Severity of LSRs Following Study Medication Application | The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit. The actual value and change from baseline in the composite LSR score were also summarized. | One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population. | Posted | Mean | Standard Deviation | units on a scale | Day 57 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Incidence of Hyperpigmentation Following Study Medication Application | The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. | One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population. | Posted | Number | participants | Baseline |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Incidence of Hyperpigmentation Following Study Medication Application | The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent) | One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population. | Posted | Number | participants | Day 57 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Incidence of Hypopigmentation Following Study Medication Application | The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent) | One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population. | Posted | Number | participants | Baseline |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Incidence of Hypopigmentation Following Study Medication Application | The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent) | One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population. | Posted | Number | participants | Day 57 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Incidence of Scarring Following Study Medication Application | The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent) | One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population. | Posted | Number | participants | Baseline |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Incidence of Scarring Following Study Medication Application | The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent). | One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population. | Posted | Number | participants | Day 57 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Complete Clearance Rate of AK Lesions; | Defined as the number of patients at the day 57 post-treatment visit with no clinically visible AK lesions in the selected treatment area | Posted | Number | participants | Day 57 |
|
57 days
One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1. PEP005 Topical Gel 0.005% | Two days treatment day 1, 2 | 0 | 32 | 8 | 32 | ||
| EG001 | 2. PEP005 Topical Gel 0.01% | Two days treatment, day 1, 2 | 0 | 34 | 5 | 34 | ||
| EG002 | 3. PEP005 Topical Gel 0.015% | Two days treatment day 1, 2 | 0 | 33 | 5 | 33 | ||
| EG003 | 4. Vehicle Gel | Two days treatment, day 1, 2 | 0 | 33 | 3 | 33 | ||
| EG004 | 5. PEP005 Topical Gel 0.005% | Three days treatment, day 1, 2, 3 | 1 | 33 | 7 | 33 | ||
| EG005 | 6. PEP005 Topical Gel 0.01% | Three days treatment, day 1, 2, 3 | 0 | 34 | 8 | 34 | ||
| EG006 | 7. PEP005 Topical Gel 0.015% | Three days treatment, day 1, 2, 3 | 1 | 32 | 12 | 32 | ||
| EG007 | 8. Vehicle Gel | Three days treatment, day 1, 2, 3 | 0 | 33 | 0 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| APPLICATION SITE IRRITATION | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| APPLICATION SITE PRURITUS | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| APPLICATION SITE DISCOMFORT | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| APPLICATION SITE SWELLING | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| APPLICATION SITE PAIN | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| APPLICATION SITE INFECTION | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| EYELID OEDEMA | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
The Institution and Investigator agree not to publish the results of this study without the prior written consent of Sponsor. As used herein, the term 'publish' shall include oral presentations, written abstracts, written manuscripts, etc.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | Leo Pharma A/S | +45 4494 5888 | ctr.disclosure@leo-pharma.com |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Australia |
|
| 6. PEP005 Topical Gel 0.01% |
Three days treatment, day 1, 2, 3 |
| OG006 | 7. PEP005 Topical Gel 0.015% | Three days treatment, day 1, 2, 3 |
| OG007 | 8. Vehicle Gel | Three days treatment, day 1, 2, 3 |
|
|
| OG005 |
| 6. PEP005 Topical Gel 0.01% |
Three days treatment, day 1, 2, 3 |
| OG006 | 7. PEP005 Topical Gel 0.015% | Three days treatment, day 1, 2, 3 |
| OG007 | 8. Vehicle Gel | Three days treatment, day 1, 2, 3 |
|
|
Two days treatment, day 1, 2
| OG004 | 5. PEP005 Topical Gel 0.005% | Three days treatment, day 1, 2, 3 |
| OG005 | 6. PEP005 Topical Gel 0.01% | Three days treatment, day 1, 2, 3 |
| OG006 | 7. PEP005 Topical Gel 0.015% | Three days treatment, day 1, 2, 3 |
| OG007 | 8. Vehicle Gel | Three days treatment, day 1, 2, 3 |
|
|
Two days treatment, day 1, 2
| OG004 | 5. PEP005 Topical Gel 0.005% | Three days treatment, day 1, 2, 3 |
| OG005 | 6. PEP005 Topical Gel 0.01% | Three days treatment, day 1, 2, 3 |
| OG006 | 7. PEP005 Topical Gel 0.015% | Three days treatment, day 1, 2, 3 |
| OG007 | 8. Vehicle Gel | Three days treatment, day 1, 2, 3 |
|
|
Three days treatment, day 1, 2, 3
| OG005 | 6. PEP005 Topical Gel 0.01% | Three days treatment, day 1, 2, 3 |
| OG006 | 7. PEP005 Topical Gel 0.015% | Three days treatment, day 1, 2, 3 |
| OG007 | 8. Vehicle Gel | Three days treatment, day 1, 2, 3 |
|
|
| OG004 | 5. PEP005 Topical Gel 0.005% | Three days treatment, day 1, 2, 3 |
| OG005 | 6. PEP005 Topical Gel 0.01% | Three days treatment, day 1, 2, 3 |
| OG006 | 7. PEP005 Topical Gel 0.015% | Three days treatment, day 1, 2, 3 |
| OG007 | 8. Vehicle Gel | Three days treatment, day 1, 2, 3 |
|
|
| OG004 | 5. PEP005 Topical Gel 0.005% | Three days treatment, day 1, 2, 3 |
| OG005 | 6. PEP005 Topical Gel 0.01% | Three days treatment, day 1, 2, 3 |
| OG006 | 7. PEP005 Topical Gel 0.015% | Three days treatment, day 1, 2, 3 |
| OG007 | 8. Vehicle Gel | Three days treatment, day 1, 2, 3 |
|
|
| OG004 | 5. PEP005 Topical Gel 0.005% | Three days treatment, day 1, 2, 3 |
| OG005 | 6. PEP005 Topical Gel 0.01% | Three days treatment, day 1, 2, 3 |
| OG006 | 7. PEP005 Topical Gel 0.015% | Three days treatment, day 1, 2, 3 |
| OG007 | 8. Vehicle Gel | Three days treatment, day 1, 2, 3 |
|
|
| OG004 |
| 5. PEP005 Topical Gel 0.005% |
Three days treatment, day 1, 2, 3 |
| OG005 | 6. PEP005 Topical Gel 0.01% | Three days treatment, day 1, 2, 3 |
| OG006 | 7. PEP005 Topical Gel 0.015% | Three days treatment, day 1, 2, 3 |
| OG007 | 8. Vehicle Gel | Three days treatment, day 1, 2, 3 |
|
|
| OG004 |
| 5. PEP005 Topical Gel 0.005% |
Three days treatment, day 1, 2, 3 |
| OG005 | 6. PEP005 Topical Gel 0.01% | Three days treatment, day 1, 2, 3 |
| OG006 | 7. PEP005 Topical Gel 0.015% | Three days treatment, day 1, 2, 3 |
| OG007 | 8. Vehicle Gel | Three days treatment, day 1, 2, 3 |
|
|
Three days treatment, day 1, 2, 3 |
| OG006 | 7. PEP005 Topical Gel 0.015% | Three days treatment, day 1, 2, 3 |
| OG007 | 8. Vehicle Gel | Three days treatment, day 1, 2, 3 |
|
|