## Protocol Section
### Identification Module
**NCT ID:** NCT01778179

**Brief Title:** A Fixed Triple Combination Cream for Solar Lentigines Associated to Cryotherapy

**Official Title:** Safety and Efficacy of a Triple Combination Cream as Adjuvant Treatment of Solar Lentigines With Cryotherapy.

#### Organization Study ID Info
**ID:** 2012-03
#### Organization
**Class:** OTHER
**Full Name:** Brazilan Center for Studies in Dermatology
### Status Module
#### Completion Date
**Date:** 2012-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-10-14

**Type:** ACTUAL

**Last Update Submit Date:** 2020-09-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-12

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2020-09-17

**Type:** ACTUAL

**Results First Submit Date:** 2020-08-11

**Results First Submit QC Date:** 2020-08-27

#### Start Date
**Date:** 2011-04

**Status Verified Date:** 2020-09

#### Study First Post Date
**Date:** 2013-01-29
**Type:** ESTIMATED
**Study First Submit Date:** 2013-01-04
**Study First Submit QC Date:** 2013-01-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Brazilan Center for Studies in Dermatology

#### Responsible Party

**Investigator Affiliation:** Brazilan Center for Studies in Dermatology

**Investigator Full Name:** Doris Hexsel

**Investigator Title:** MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy when used in the pre- and post-procedure phases for the treatment of solar lentigines on the back of the hands and in the prevention of post-inflammatory hyperpigmentation after cryotherapy.

**Detailed Description:** To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy when used in the pre- and post-procedure phases for the treatment of solar lentigines on the back of the hands and in the prevention of post-inflammatory hyperpigmentation after cryotherapy.

The study has 13 weeks for each subject. Five visits will take place: at Baseline, week 2, 5, 9 and 13 after the cryotherapy.

### Conditions Module

**Conditions:**

- Solar Lentigines

**Keywords:**

- Lentigines

- Cryotherapy

- hyperpigmentation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects (group 1) will be treated daily for their solar lentigines with the investigational drug (Tri-Luma® cream) plus sunscreen for 2 weeks. At week 2, all the subjects will have the solar lentigines treated by cryotherapy (CRY-AC3® device).

Post-procedure phase (From Week 2 up to Week 13)

* Topical antibiotic treatment phase (Week 2 up to Week 5 - visit 2 to visit 3): At week 2, all the subjects will start to apply a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks.
* Treatment phase 2 (from week 5 up to week 13 - visit 3 up to visit 5):

The investigational drug (Tri-Luma® cream) plus sunscreen will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH.

**Intervention Names:**

- Drug: Tri-luma

- Procedure: Cryotherapy (CRY-AC3® device)

**Label:** Group 1

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Subjects (group 2) will be treated daily for their solar lentigines with sunscreen alone for 2 weeks. At week 2, all the subjects will have the solar lentigines will treated by cryotherapy (CRY-AC3® device).

Post-procedure phase (Week 2 up to Week 13)

* Topical antibiotic treatment phase (Week 2 up to Week 5 - visit 2 to visit 3): At week 2, all the subjects will start to apply a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks.
* Treatment phase 2 (from week 5 up to week 13 - visit 3 up to visit 5):

Sunscreen alone will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH.

**Intervention Names:**

- Procedure: Cryotherapy (CRY-AC3® device)

**Label:** Group 2

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group 1

**Description:** Pre-procedure phase (From Baseline up to Week 2) treated daily for their solar lentigines with the investigational drug (Tri-Luma® cream) for 2 weeks.

Post-procedure phase (From week 2 up to Week 13 - Visit )

- Tri-Luma® cream treatment phase (from week 5 up to week 13 - visit 3 up to visit 5):The investigational drug (Tri-Luma® cream) will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH.

**Name:** Tri-luma

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Group 1

- Group 2

**Description:** Procedure performed at week 2.

**Name:** Cryotherapy (CRY-AC3® device)

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Solar lentigines count up to 13 weeks

**Measure:** Solar Lentigines Count

**Time Frame:** up to 13 weeks

#### Secondary Outcomes

**Description:** This assessment was made using a narrowband reﬂectance spectrophotometer (Mexameter MX18®, Courage-Khazaka, Germany). The measurement is based on absorption/reflection. The probe of the Mexameter® MX 18 emits three specific light wavelengths. A receiver measures the light reflected by the skin. As the quantity of emitted light is defined, the quantity of light absorbed by the skin can be calculated. The melanin is measured by two specific wavelengths (red: 660 nm and near infrared: 880 nm) chosen to correspond to different absorption rates by the pigments.

The quantification of melanin is presented as a value that varies from 0-999. The higher the value, the larger is the amount of melanin on the skin.

**Measure:** Change From Baseline in Melanin Levels

**Time Frame:** Baseline and up to 13 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subject agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol;
* Female and male subjects;
* Phototype II to IV;
* Subjects aged between 40 and 65 years;
* Subjects presenting at least 5 lesions of solar lentigines at the back hands with al least 3mm of diameter
* History of post-inflammatory hyperpigmentation on body or face
* Medical history and physical examination which, based on the investigator's opinion, do not prevent the subject from taking part in the study or from making use of the products under investigation;
* Subjects of childbearing age should present a negative urine pregnancy test at baseline and should be using a highly effective contraceptive method during all study;
* Availability of the subject throughout the study;
* Subject agreeing not to undergo other cosmetic or dermatological procedures during the participation in the study;
* Subjects with sufficient schooling and knowledge to enable them to cooperate to the degree required by the protocol.

Exclusion Criteria:

* Pregnant women or women intending to become pregnant in the following 5 months after screening;
* Lactation period;
* Subjects participating in other clinical trials;
* Any prior cosmetic procedures, including fillers, or scars that may interfere with the study results;
* Subjects with neoplastic, muscular or neurological diseases;
* Subjects with inflammation or active infection in the area to be studied;
* Subjects with a history of adverse effects, such as sensitivity to the components of any of the study drug formula,
* Subjects with a history of non-adherence to medical treatment or showing unwillingness to adhere to the study protocol;
* Any condition that, in the opinion of the investigator, can compromise the evaluation of the study.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Brazilian Center for Studies in Dermatology

**Name:** Doris Hexsel, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008548

- Term: Melanosis

- ID: D000017495

- Term: Hyperpigmentation

- ID: D000010859

- Term: Pigmentation Disorders

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10923

- Name: Lentigo

- Relevance: HIGH

- As Found: Lentigo

- ID: M19760

- Name: Hyperpigmentation

- Relevance: LOW

- As Found: Unknown

- ID: M11531

- Name: Melanosis

- Relevance: LOW

- As Found: Unknown

- ID: M13754

- Name: Pigmentation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007911

- Term: Lentigo

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Derm

- Name: Dermatologic Agents

### Intervention Browse Module - Browse Leaves

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M16255

- Name: Sunscreening Agents

- Relevance: LOW

- As Found: Unknown

- ID: M12300

- Name: Neomycin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Group 1

**Deaths Num At Risk:** 25

**Description:** Subjects treated daily for their solar lentigines with the triple combination (hydroquinone 4% tretinoin 0.05% fluocinolone acetonide 0.01%; Tri-Luma® cream) plus sunscreen for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device).

Post-procedure phase (Week 2 up to Week 13)

* Topical antibiotic treatment (Week 2 to Week 5): All the subjects applied a topical antibiotic (Neomycin/Nebacetin® ointment) for the following 3 weeks.
* Second treatment phase (Week 5 to Week 13):

Subjects of group 1 applied Tri-Luma® cream plus sunscreen again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of PIH.

**ID:** EG000

**Other Num Affected:** 3

**Other Num at Risk:** 25

**Serious Number At Risk:** 25

**Title:** Group 1

**Group ID:** EG001

**Title:** Group 2

**Deaths Num At Risk:** 25

**Description:** Subjects treated daily for their solar lentigines with sunscreen only for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device).

Post-procedure phase (Week 2 up to Week 13)

* Topical antibiotic treatment phase (Week 2 to Week 5): All the subjects applied a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks.
* Second treatment phase (Week 5 to Week 13):

Subjects of group 2 applied sunscreen only again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of PIH.

**ID:** EG001

**Other Num Affected:** 2

**Other Num at Risk:** 25

**Serious Number At Risk:** 25

**Title:** Group 2

**Frequency Threshold:** 0

#### Other Events

**Term:** Erythema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Residual blisters from cryotherapy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Time Frame:** Up to 13 weeks

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 25

**Group ID:** BG001

**Value:** 25

**Group ID:** BG002

**Value:** 50

**Units:** Participants

### Group

**ID:** BG000

**Title:** Group 1

**Description:** Subjects treated daily for their solar lentigines with the triple combination (hydroquinone 4% tretinoin 0.05% fluocinolone acetonide 0.01%; Tri-Luma® cream) plus sunscreen for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device).

Post-procedure phase (Week 2 up to Week 13)

* Topical antibiotic treatment (Week 2 to Week 5): All the subjects applied a topical antibiotic (Neomycin/Nebacetin® ointment) for the following 3 weeks.
* Second treatment phase (Week 5 to Week 13):

Subjects of group 1 applied Tri-Luma® cream plus sunscreen again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of PIH.

### Group

**ID:** BG001

**Title:** Group 2

**Description:** Subjects treated daily for their solar lentigines with sunscreen only for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device).

Post-procedure phase (Week 2 up to Week 13)

* Topical antibiotic treatment phase (Week 2 to Week 5): All the subjects applied a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks.
* Second treatment phase (Week 5 to Week 13):

Subjects of group 2 applied sunscreen only again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of PIH.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 4

**Value:** 59

#### Measurement

**Group ID:** BG001

**Spread:** 6

**Value:** 56

#### Measurement

**Group ID:** BG002

**Spread:** 5

**Value:** 58

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 23

#### Measurement

**Group ID:** BG001

**Value:** 24

#### Measurement

**Group ID:** BG002

**Value:** 47

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 25

#### Measurement

**Group ID:** BG001

**Value:** 24

#### Measurement

**Group ID:** BG002

**Value:** 49

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 25

#### Measurement

**Group ID:** BG001

**Value:** 25

#### Measurement

**Group ID:** BG002

**Value:** 50

**Class Title:** Brazil

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** doris@hexsel.com.br
**Organization:** Brazilian Center for Studies in Dermatology
**Phone:** +55 51 30262633
**Title:** Dr. Doris Hexsel
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.0
- **Upper Limit:** 
- **Value:** 25.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 11.0
- **Upper Limit:** 
- **Value:** 26.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.0
- **Upper Limit:** 
- **Value:** 8.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.0
- **Upper Limit:** 
- **Value:** 11.0
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 69
- **Upper Limit:** 
- **Value:** 297
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 68
- **Upper Limit:** 
- **Value:** 279
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 59
- **Upper Limit:** 
- **Value:** -95
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 65
- **Upper Limit:** 
- **Value:** -41
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Solar lentigines count up to 13 weeks
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** up to 13 weeks
**Title:** Solar Lentigines Count
**Type:** PRIMARY
**Unit of Measure:** Number of solar lentigines
##### Group
**Description:** Subjects treated daily for their solar lentigines with the triple combination (hydroquinone 4% tretinoin 0.05% fluocinolone acetonide 0.01%; Tri-Luma® cream) plus sunscreen for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device).

Post-procedure phase (Week 2 up to Week 13)

* Topical antibiotic treatment (Week 2 to Week 5): All the subjects applied a topical antibiotic (Neomycin/Nebacetin® ointment) for the following 3 weeks.
* Second treatment phase (Week 5 to Week 13):

Subjects of group 1 applied Tri-Luma® cream plus sunscreen again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of PIH.
**ID:** OG000
**Title:** Group 1
##### Group
**Description:** Subjects treated daily for their solar lentigines with sunscreen only for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device).

Post-procedure phase (Week 2 up to Week 13)

* Topical antibiotic treatment phase (Week 2 to Week 5): All the subjects applied a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks.
* Second treatment phase (Week 5 to Week 13):

Subjects of group 2 applied sunscreen only again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of PIH.
**ID:** OG001
**Title:** Group 2
#### Outcome Measure 2
**Description:** This assessment was made using a narrowband reﬂectance spectrophotometer (Mexameter MX18®, Courage-Khazaka, Germany). The measurement is based on absorption/reflection. The probe of the Mexameter® MX 18 emits three specific light wavelengths. A receiver measures the light reflected by the skin. As the quantity of emitted light is defined, the quantity of light absorbed by the skin can be calculated. The melanin is measured by two specific wavelengths (red: 660 nm and near infrared: 880 nm) chosen to correspond to different absorption rates by the pigments.

The quantification of melanin is presented as a value that varies from 0-999. The higher the value, the larger is the amount of melanin on the skin.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline and up to 13 weeks
**Title:** Change From Baseline in Melanin Levels
**Type:** SECONDARY
**Unit of Measure:** Arbitrary units
##### Group
**Description:** Subjects treated daily for their solar lentigines with the triple combination (hydroquinone 4% tretinoin 0.05% fluocinolone acetonide 0.01%; Tri-Luma® cream) plus sunscreen for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device).

Post-procedure phase (Week 2 up to Week 13)

* Topical antibiotic treatment (Week 2 to Week 5): All the subjects applied a topical antibiotic (Neomycin/Nebacetin® ointment) for the following 3 weeks.
* Second treatment phase (Week 5 to Week 13):

Subjects of group 1 applied Tri-Luma® cream plus sunscreen again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of PIH.
**ID:** OG000
**Title:** Group 1
##### Group
**Description:** Subjects treated daily for their solar lentigines with sunscreen only for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device).

Post-procedure phase (Week 2 up to Week 13)

* Topical antibiotic treatment phase (Week 2 to Week 5): All the subjects applied a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks.
* Second treatment phase (Week 5 to Week 13):

Subjects of group 2 applied sunscreen only again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of PIH.
**ID:** OG001
**Title:** Group 2
### Participant Flow Module
#### Group
**Description:** Subjects treated daily for their solar lentigines with the triple combination (hydroquinone 4% tretinoin 0.05% fluocinolone acetonide 0.01%; Tri-Luma® cream) plus sunscreen for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device).

Post-procedure phase (Week 2 up to Week 13)

* Topical antibiotic treatment (Week 2 to Week 5): All the subjects applied a topical antibiotic (Neomycin/Nebacetin® ointment) for the following 3 weeks.
* Second treatment phase (Week 5 to Week 13):

Subjects of group 1 applied Tri-Luma® cream plus sunscreen again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of post inflammatory hyperpigmentation.
**ID:** FG000
**Title:** Group 1
#### Group
**Description:** Subjects treated daily for their solar lentigines with sunscreen only for 2 weeks. At week 2, all the subjects had the solar lentigines treated by cryotherapy (CRY-AC3® device).

Post-procedure phase (Week 2 up to Week 13)

* Topical antibiotic treatment phase (Week 2 to Week 5): All the subjects applied a topical antibiotic (Neomycin/Nebacetin® ointment) for the next 3 weeks.
* Second treatment phase (Week 5 to Week 13):

Subjects of group 2 applied sunscreen only again for a minimum of 4 weeks and up to 8 weeks, depending on the Global Improvement of solar lentigines score and absence of post inflammatory hyperpigmentation.
**ID:** FG001
**Title:** Group 2
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 25
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 25
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 23
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 22
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
**Has Results:** True