Photodamaged SkinPhase 4NCT04096742
Altreno for Chest Rejuvenation
A Phase 4 study testing tretinoin 0.05% lotion (Altreno) in people with Photodamaged Skin and Photoaging, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial summary
This is a single-center, prospective, double-blind, randomized, vehicle-controlled study to evaluate the efficacy, safety and patient satisfaction of tretinoin 0.05% lotion (Altreno) for chest rejuvenation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Photodamaged Skin, Photoaging
- What is being tested?
- tretinoin 0.05% lotion (Altreno)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2019to 31 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females or males age 18-65, Fitzpatrick skin types I-VI
- Moderate to severe photodamage (Fitzpatrick Wrinkle score of 4-9)
- Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedures.
- Willingness to abstain from any other procedures to the areas to be treated throughout the trial period.
- Willingness and ability to comply with protocol requirements, including adherence to photography and returning for follow-up visits.
- Women of childbearing potential willing to use an acceptable form of birth control during trial period.
Show all 12Show fewer
- Hormonal contraception - pill, injection, implant, patch, vaginal ring, Intrauterine device
- Intrauterine coil
- Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
- Abstinence (If practicing abstinence must agree to use barrier method described above (c) if becomes sexually active).
- Vasectomized partner (Must agree to use barrier method described above (c) if becomes sexually active with an Un-Vasectomized partner).
- Female patients will be either of non-childbearing potential defined as: Having no uterus and/or both ovaries, postmenopausal (no menses for at least 12 months prior), or has had a bilateral tubal ligation at least 6 months prior to study enrollment.
Who cannot join
- Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial.
- Known hypersensitivity or allergy to the components of the study medication.
- Concurrent enrollment in any study involving the use of investigational devices or drugs.
- Current smoker or history of smoking in the last five years.
- Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.
- Presence of an active systemic or local skin disease that may affect treatment area.
Show all 20Show fewer
- History of prior surgery to the treatment area
- History of prior significant trauma to the chest
- History of the following cosmetic treatments to the area(s) to be treated:
- Energy based device or laser procedure to the chest within the past 6 months (Ultherapy, ablative and non-ablative laser, intense pulsed light, etc)
- Injectable filler of any type to the chest in the past 2 years (Hyaluronic acid fillers (Voluma, Belotero), Poly-L-Lactic acid fillers (e.g. Sculptra), and CaHA fillers (e.g. Radiesse)
- Ever for permanent fillers (e.g. Silicone, ArteFill)
- Surgical dermabrasion or chemical peels in the treatment area within the past 6 month
- Any planned surgical intervention to the chest for the duration of the trial
- Any visible surface alteration to the chest that may interfere with evaluation, at investigator discretion
- Any pre-existing medical condition that may interfere with study compliance or evaluation, at investigator discretion
- Inability to comply with all study protocols and regulations
- Current taking an immunosuppressant or applying a topical corticosteroid to the affected area
- Unwilling to minimize exposure to sunlight and sunlamps during the course of the study.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Cosmetic Laser Dermatology/West Dermatology Research Center
San Diego, California, 92121
About this study
Official title: A Prospective, Randomized, Double-blind, Vehicle-controlled Study Evaluating the Efficacy, Safety and Patient Satisfaction of Tretinoin 0.05% Lotion (Altreno) for Chest Rejuvenation.
This is a single-center, prospective, double-blind, randomized, vehicle-controlled study to evaluate the efficacy, safety and patient satisfaction of tretinoin 0.05% lotion (Altreno) for chest rejuvenation.
- Conditions
- Photodamaged Skin, Photoaging
- Being tested
- tretinoin 0.05% lotion (Altreno), Vehicle
- Keywords
- Skin, Chest, Photodamage, Sun Damage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tretinoin 0.05% lotion (Altreno)Drug
Altreno topical lotion
VehicleOther
Lotion not containing active ingredient (tretinoin)
| Study group | Role | What they receive |
|---|---|---|
| Altreno | Experimental | tretinoin 0.05% lotion (Altreno) Receives: Drug: tretinoin 0.05% lotion (Altreno) |
| Vehicle | Sham comparator | Vehicle lotion not containing tretinoin Receives: Other: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Quality
Nine-point scale to assess skin quality for the appearance of crepiness, coarse lines/wrinkles, skin texture, and skin tone evenness
Measured: Baseline through Month 6
Secondary outcomes (6)
Investigator Assessment-Fabi-Bolton Wrinkle Scale (FBWS)
Fabi-Bolton Wrinkle Scale (FBWS)
Measured: Baseline through Month 6
Investigator Assessment-Investigator Percent Improvement Evaluation
Investigator Percent Improvement Evaluation
Measured: 1, 3, and 6 months
Investigator Assessment-Investigator Global aesthetic improvement scale (I-GAIS)
Investigator Global aesthetic improvement scale (I-GAIS)
Measured: 1, 3, and 6 months
Subject Assessments-Subject Global aesthetic improvement scale (S-GAIS)
Subject Global aesthetic improvement scale (S-GAIS)
Measured: 1, 3, and 6 months
Subject Assessments-Patient satisfaction score
Patient satisfaction score
Measured: 1, 3, and 6 months
Subject Assessments-End of study patient questionnaire
End of study patient questionnaire
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start6 Aug 2019
- Primary completion30 Jul 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photodamaged SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, prospective, double-blind, randomized, vehicle-controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Responsible party
- Sponsor
- Investigators
- Sabrina Fabi, MD, Principal investigator, Cosmetic Laser Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096742
- Sponsor's protocol ID
- Altreno-2019-01
- Status last verified
- Apr 2021
- First submitted
- 18 Sep 2019
- Last updated
- 2 Apr 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Vehicle-controlled Study Evaluating the Efficacy, Safety and Patient Satisfaction of Tretinoin 0.05% Lotion (Altreno) for Chest Rejuvenation.
- ClinicalTrials.gov ID
- NCT04096742
- Acronym / sponsor ID
- Altreno-2019-01
- Conditions
- Photodamaged Skin, Photoaging
- Keywords
- Skin, Chest, Photodamage, Sun Damage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, prospective, double-blind, randomized, vehicle-controlled study to evaluate the efficacy, safety and patient satisfaction of tretinoin 0.05% lotion (Altreno) for chest rejuvenation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a single-center, prospective, double-blind, randomized, vehicle-controlled study
| Arm | Type | Receives |
|---|---|---|
| Altreno | Experimental | Drug: tretinoin 0.05% lotion (Altreno)tretinoin 0.05% lotion (Altreno) |
| Vehicle | Sham comparator | Other: VehicleVehicle lotion not containing tretinoin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Females or males age 18-65, Fitzpatrick skin types I-VI
- Moderate to severe photodamage (Fitzpatrick Wrinkle score of 4-9)
- Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedures.
- Willingness to abstain from any other procedures to the areas to be treated throughout the trial period.
- Willingness and ability to comply with protocol requirements, including adherence to photography and returning for follow-up visits.
Key exclusion criteria (20 listed)
- Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial.
- Known hypersensitivity or allergy to the components of the study medication.
- Concurrent enrollment in any study involving the use of investigational devices or drugs.
- Current smoker or history of smoking in the last five years.
- Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tretinoin 0.05% lotion (Altreno)Altreno topical lotion | Drug | Altreno |
| VehicleLotion not containing active ingredient (tretinoin) | Other | Vehicle |
Primary outcome
Skin Quality
Time frame: Baseline through Month 6
Nine-point scale to assess skin quality for the appearance of crepiness, coarse lines/wrinkles, skin texture, and skin tone evenness
6 secondary outcomes
Investigator Assessment-Fabi-Bolton Wrinkle Scale (FBWS)
Time frame: Baseline through Month 6
Investigator Assessment-Investigator Percent Improvement Evaluation
Time frame: 1, 3, and 6 months
Investigator Assessment-Investigator Global aesthetic improvement scale (I-GAIS)
Time frame: 1, 3, and 6 months
Subject Assessments-Subject Global aesthetic improvement scale (S-GAIS)
Time frame: 1, 3, and 6 months
Subject Assessments-Patient satisfaction score
Time frame: 1, 3, and 6 months
Subject Assessments-End of study patient questionnaire
Time frame: Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Photodamaged Skin
Recruiting
Multimodal Laser Treatment of Photodamaged Skin
Photo-damage, Actinic Keratosis (AK)
Not yet recruitingPhase 2/3
Study Comparing Two Serums With Intense Pulsed Light for the Treatment of Moderate to Severe Photodamage and Crepiness on the Forearms
Photodamaged Skin
Not yet recruiting
A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery
Photodamaged Skin, Skin Cancer Prevention
Recruiting
2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles
Photodamaged Skin, Rhytids
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabrina Fabi, MD principal investigator
Cosmetic Laser Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tretinoin 0.05% lotion (Altreno) in people with Photodamaged Skin and Photoaging, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Quality (time frame: Baseline through Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.