Skin CareNCT03302559

Study to Assess the Cosmetic Changes in the Facial Skin After Use of a Topical Retinoid Product in Participants With Moderate to Severe Photodamage

A study testing Retinol Complex 0.5, Facial cleanser and Moisturizing lotion in people with Skin Care, run by Allergan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will assess the cosmetic changes of a cosmetic topical retinoid product in participants with moderate to severe photodamage utilizing non-invasive in vivo skin imaging instrumentation. Read more about this study

Who is it for?: Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Skin Care
What is being tested?: Retinol Complex 0.5, Facial cleanser and Moisturizing lotion
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteUnited States
Study dates: 18 Sep 2017to 30 Apr 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants with Fitzpatrick skin type I-IV
Presence of moderate to severe facial photodamage
Participants taking hormone replacement or hormones for birth control, willing to stop or change this medication for the duration of the study
Willingness to cleanse the face and remove all makeup at least 15 minutes prior to each scheduled clinic visit
Willingness to not use any other products, including self-tanners on their facial skin during the study
Willingness to avoid as much as possible, direct and prolonged sun exposure for the duration of the study (including tanning beds), especially from 10 AM to 2 PM. Participants are asked to wear protective clothing prior to and during exposure.

Who cannot join

Individuals with active symptoms of allergy, cold sore or warts, active psoriasis or eczema, rosacea, sunburn, open wounds, neurotic excoriations, excessive scarring, tattoos, or other skin conditions in the test areas that would interfere with the assessments of this study
Individuals who are nursing, pregnant, or planning to become pregnant during the study
Individuals with uncontrolled disease such as diabetes, hypertension, hyper or hypothyroidism, active hepatitis, immune deficiency, or autoimmune
Individuals who have a pre-existing or dormant dermatologic condition (e.g., psoriasis, atopic dermatitis, rosacea, skin cancer, etc.)
Individuals who require electrolysis, waxing, or use depilatories on the face during the study
Chemical peel or microdermabrasion within 4 weeks of study start

Show all 10Show fewer

Retin-A®, Retin-A Micro®, Renova®, Avita®,Tazorac®, Avage® or Differin® or other similar prescription drugs within 3 months of study start
Cosmetic injections (filler and/or toxins, i.e. Juvederm, Radiesse, Botox, etc.), non-ablative laser or fractional laser resurfacing
Accutane® or other oral retinoid, Ablative procedures (i.e. laser, chemical, cosmetic surgeries) within 12 months of study start
Participants who have planned surgeries or procedures.

Trial locations and contacts

1 site in 1 country.

United States1 site

SkinMedica Clinical Research and Innovation Center
Irvine, California, 92612

Other trials in United States

About this study

Official title: Assessing the Cosmetic Changes in the Facial Skin Utilizing Non-Invasive In Vivo Skin Imaging Instrumentation After Use of a Topical Retinoid Product In Subjects With Moderate to Severe Photodamage

This study will assess the cosmetic changes of a cosmetic topical retinoid product in participants with moderate to severe photodamage utilizing non-invasive in vivo skin imaging instrumentation.

Conditions: Skin Care
Being tested: Retinol Complex 0.5, Facial cleanser, Moisturizing lotion, Sunscreen, Skin Imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Retinol Complex 0.5Other
Also called SkinMedica Retinol Complex 0.5
Retinol Complex 0.5 topically in the evening.
Facial cleanserOther
Also called SkinMedica Facial Cleanser
Facial cleanser in the morning and in the evening.
Moisturizing lotionOther
Also called Cetaphil Fragrance Free Moisturizing Lotion
Fragrance free moisturizing lotion in the morning and in the evening.
SunscreenOther
Also called SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35
Sunscreen broad spectrum sun protection factor (SPF) 35 topically in the morning and as needed.
Skin ImagingDevice
Non-invasive in vivo skin imaging will be taken with the VivoSight Dx Optical Coherence Tomography (OCT) and VivaScope 1500

Study groups in NCT03302559
Study group	Role	What they receive
Retinol Complex 0.5	Experimental	During a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging. Receives: Other: Retinol Complex 0.5; Other: Facial cleanser; Other: Moisturizing lotion; Other: Sunscreen; Device: Skin Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Overall Photodamage Score
The investigator assessed the participant's overall photodamage using a 10-point scale where None (0)= Facial skin is smooth to the touch, without significant fine/coarse line or skin tone unevenness in any areas (periocular, cheeks, forehead and perioral areas) to Severe (7 to 9)= Facial skin shows 3 or more areas (periocular, cheeks, forehead and perioral areas) of significant roughness, skin tone unevenness (red/brown), or fine/coarse lines at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Measured: Baseline (Day 1) to Week 12
Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
The investigator assessed the participant's appearance of fine lines/wrinkles using a 10-point scale where None (0)= No fine lines/wrinkles present; skin looks completely smooth and wrinkle-free to Severe (7 to 9)= Many coarse lines/wrinkles densely packed together in the treatment area (forehead, periocular, cheeks and perioral areas) at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Measured: Baseline (Day 1) to Week 12
Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
The investigator assessed the participant's appearance of coarse lines/wrinkles using a 10-point scale where None (0)= No coarse lines/wrinkles present; skin looks completely smooth and wrinkle-free to Severe (7 to 9)= Many coarse lines/wrinkles densely packed together in the treatment area (forehead, periocular, cheeks and perioral areas) at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Measured: Baseline (Day 1) to Week 12
Change From Baseline in Tactile Roughness Score
The investigator assessed the participant's tactile roughness in the entire face using a 10-point scale where None (0)= No roughness of the treatment area; skin is completely smooth and pliable to Severe (7 to 9)= Marked roughness of the treatment area associated with stiff feeling at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Measured: Baseline (Day 1) to Week 12

Secondary outcomes (7)

Change From Baseline in Skin Roughness Score Using the Allergan Skin Roughness Visual Scale
The investigator assessed the participant's skin roughness using the Allergan Skin Roughness Visual 5-Point Scale where None (0)= Smooth visual skin texture to Extreme (4)= Extremely coarse visual skin texture, crosshatched deep creases; extreme elastosis at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Measured: Baseline (Day 1) to Week 12
Change From Baseline in Appearance of Fine Lines Score Using the Allergan Fine Lines Visual Scale
The investigator assessed the participant's fine lines using the Allergan Fine Lines Visual 5-Point Scale where None (0)= No fine lines to Diffuse (4)= Diffuse superficial lines; crosshatching at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Measured: Baseline (Day 1) to Week 12
Investigator's Global Improvement Assessment for Overall Photodamage
The investigator assessed the global improvement in the participant's overall photodamage compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Almost complete improvement of the condition with a trace of signs/symptoms remaining (approximately 95% or better overall improvement).
Measured: Baseline (Day 1) to Week 12
Investigator's Global Improvement Assessment for the Appearance of Fine Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)
The investigator assessed the global improvement in the participant's overall appearance of fine lines/wrinkles compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of fine lines/wrinkles (approximately 95% or better overall improvement).
Measured: Baseline (Day 1) to Week 12
Investigator's Global Improvement Assessment for the Appearance of Coarse Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)
The investigator assessed the global improvement in the participant's overall appearance of coarse lines/wrinkles compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of coarse lines/wrinkles (approximately 95% or better overall improvement).
Measured: Baseline (Day 1) to Week 12
Investigator's Global Improvement Assessment for Tactile Roughness
The investigator assessed the global improvement in the participant's overall tactile roughness compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of tactile roughness (approximately 95% or better overall improvement).
Measured: Baseline (Day 1) to Week 12
Change From Baseline in Spectrophotometer L* Value (a Measurement of Skin Brightness)
Triplicate spectrophotometer readings were taken of the participant's face (Normal Skin and Target Lesions) at Baseline and Week 12. L* value scores range from 0=black to 100=white. An increase in the spectrophotometer L* values indicates improvement. A positive change from Baseline indicates improvement.
Measured: Baseline (Day 1) to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Sep 201730 Apr 2018

First posted5 Oct 2017
Study start18 Sep 2017
Primary completion30 Apr 2018
Study completion30 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Skin CareStudies 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03302559
Sponsor's protocol ID: SCRIC17-RET05
Status last verified: Jun 2019
First submitted: 2 Oct 2017
Last updated: 4 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing the Cosmetic Changes in the Facial Skin Utilizing Non-Invasive In Vivo Skin Imaging Instrumentation After Use of a Topical Retinoid Product In Subjects With Moderate to Severe Photodamage
ClinicalTrials.gov ID: NCT03302559
Acronym / sponsor ID: SCRIC17-RET05
Conditions: Skin Care
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 18 Sep 2017 (actual)
Primary completion: 30 Apr 2018 (actual)
Study completion: 30 Apr 2018 (actual)
First posted: 5 Oct 2017 (actual)
Results: Posted 4 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will assess the cosmetic changes of a cosmetic topical retinoid product in participants with moderate to severe photodamage utilizing non-invasive in vivo skin imaging instrumentation.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Retinol Complex 0.5	Experimental	Other: Retinol Complex 0.5, Other: Facial cleanser, Other: Moisturizing lotion, Other: Sunscreen, Device: Skin ImagingDuring a 2-week washout period the participant used a basic skin care regimen (SkinMedica facial cleanser in the morning and in the evening, Cetaphil Fragrance Free Moisturizing Lotion in the morning and in the evening and SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen in the morning and as needed), followed by the same basic skin care regimen plus SkinMedica Retinol Complex 0.5 applied topically to the face in the evening for 12 Weeks. Assessments of the participant's facial skin were made utilizing investigator clinical grading, digital photography, a spectrophotometer and in vivo skin imaging.

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Participants with Fitzpatrick skin type I-IV
Presence of moderate to severe facial photodamage
Participants taking hormone replacement or hormones for birth control, willing to stop or change this medication for the duration of the study
Willingness to cleanse the face and remove all makeup at least 15 minutes prior to each scheduled clinic visit
Willingness to not use any other products, including self-tanners on their facial skin during the study

Key exclusion criteria (10 listed)

Individuals with active symptoms of allergy, cold sore or warts, active psoriasis or eczema, rosacea, sunburn, open wounds, neurotic excoriations, excessive scarring, tattoos, or other skin conditions in the test areas that would interfere with the assessments of this study
Individuals who are nursing, pregnant, or planning to become pregnant during the study
Individuals with uncontrolled disease such as diabetes, hypertension, hyper or hypothyroidism, active hepatitis, immune deficiency, or autoimmune
Individuals who have a pre-existing or dormant dermatologic condition (e.g., psoriasis, atopic dermatitis, rosacea, skin cancer, etc.)
Individuals who require electrolysis, waxing, or use depilatories on the face during the study

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
Retinol Complex 0.5Also: SkinMedica Retinol Complex 0.5Retinol Complex 0.5 topically in the evening.	Other	Retinol Complex 0.5
Facial cleanserAlso: SkinMedica Facial CleanserFacial cleanser in the morning and in the evening.	Other	Retinol Complex 0.5
Moisturizing lotionAlso: Cetaphil Fragrance Free Moisturizing LotionFragrance free moisturizing lotion in the morning and in the evening.	Other	Retinol Complex 0.5
SunscreenAlso: SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35Sunscreen broad spectrum sun protection factor (SPF) 35 topically in the morning and as needed.	Other	Retinol Complex 0.5
Skin ImagingNon-invasive in vivo skin imaging will be taken with the VivoSight Dx Optical Coherence Tomography (OCT) and VivaScope 1500	Device	Retinol Complex 0.5

Primary outcome

Change From Baseline in Overall Photodamage Score
Time frame: Baseline (Day 1) to Week 12
The investigator assessed the participant's overall photodamage using a 10-point scale where None (0)= Facial skin is smooth to the touch, without significant fine/coarse line or skin tone unevenness in any areas (periocular, cheeks, forehead and perioral areas) to Severe (7 to 9)= Facial skin shows 3 or more areas (periocular, cheeks, forehead and perioral areas) of significant roughness, skin tone unevenness (red/brown), or fine/coarse lines at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Time frame: Baseline (Day 1) to Week 12
The investigator assessed the participant's appearance of fine lines/wrinkles using a 10-point scale where None (0)= No fine lines/wrinkles present; skin looks completely smooth and wrinkle-free to Severe (7 to 9)= Many coarse lines/wrinkles densely packed together in the treatment area (forehead, periocular, cheeks and perioral areas) at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)
Time frame: Baseline (Day 1) to Week 12
The investigator assessed the participant's appearance of coarse lines/wrinkles using a 10-point scale where None (0)= No coarse lines/wrinkles present; skin looks completely smooth and wrinkle-free to Severe (7 to 9)= Many coarse lines/wrinkles densely packed together in the treatment area (forehead, periocular, cheeks and perioral areas) at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.
Change From Baseline in Tactile Roughness Score
Time frame: Baseline (Day 1) to Week 12
The investigator assessed the participant's tactile roughness in the entire face using a 10-point scale where None (0)= No roughness of the treatment area; skin is completely smooth and pliable to Severe (7 to 9)= Marked roughness of the treatment area associated with stiff feeling at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.

7 secondary outcomes

Change From Baseline in Skin Roughness Score Using the Allergan Skin Roughness Visual Scale
Time frame: Baseline (Day 1) to Week 12
Change From Baseline in Appearance of Fine Lines Score Using the Allergan Fine Lines Visual Scale
Time frame: Baseline (Day 1) to Week 12
Investigator's Global Improvement Assessment for Overall Photodamage
Time frame: Baseline (Day 1) to Week 12
Investigator's Global Improvement Assessment for the Appearance of Fine Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)
Time frame: Baseline (Day 1) to Week 12
Investigator's Global Improvement Assessment for the Appearance of Coarse Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)
Time frame: Baseline (Day 1) to Week 12
Investigator's Global Improvement Assessment for Tactile Roughness
Time frame: Baseline (Day 1) to Week 12
Change From Baseline in Spectrophotometer L* Value (a Measurement of Skin Brightness)
Time frame: Baseline (Day 1) to Week 12

Results and safety

Results posted to the registry on 4 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Retinol Complex 0.5	29	23

Primary outcome: Change From Baseline in Overall Photodamage Score

Time frame: Baseline (Day 1) to Week 12. Mean (Standard Deviation). Unit: score on a scale

Measure	Retinol Complex 0.5 n = 23
Baseline (BL)	5.6 (0.9)
Change from BL at Week 12	-0.8 (0.5)

Retinol Complex 0.5: p <0.001, Paired t-test

Population analysed: ITT Population included all enrolled participants who applied the test product and completed one follow-up visit after test product was initiated.

Primary outcome: Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)

Time frame: Baseline (Day 1) to Week 12. Mean (Standard Deviation). Unit: score on a scale

Measure	Retinol Complex 0.5 n = 23
Baseline (Forehead)	3.4 (1.5)
Change from BL at Week 12 (Forehead)	-0.8 (1.2)
Baseline (Periocular)	4.7 (1.5)
Change from BL at Week 12 (Periocular)	-1.0 (1.8)
Baseline (Cheeks)	3.6 (1.5)
Change from BL at Week 12 (Cheeks)	-1.1 (1.3)
Baseline (Perioral)	4.0 (1.6)
Change from BL at Week 12 (Perioral)	-0.9 (1.2)

Retinol Complex 0.5: p = 0.005, Paired t-test
Retinol Complex 0.5: p = 0.02, Paired t-test
Retinol Complex 0.5: p = 0.0006, Paired t-test

Population analysed: ITT Population included all enrolled participants who applied the test product and completed one follow-up visit after test product was initiated.

Primary outcome: Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)

Time frame: Baseline (Day 1) to Week 12. Mean (Standard Deviation). Unit: score on a scale

Measure	Retinol Complex 0.5 n = 23
Baseline (Forehead)	4.9 (1.4)
Change from BL at Week 12 (Forehead)	-0.6 (1.1)
Baseline (Periocular)	6.0 (1.2)
Change from Baseline at Week 12 (Periocular)	-0.7 (1.0)
Baseline (Cheeks)	3.5 (2.4)
Change from Baseline at Week 12 (Cheeks)	-1.1 (1.1)
Baseline (Perioral)	4.4 (1.9)
Change from BL at Week 12 (Perioral)	-0.2 (1.2)

Retinol Complex 0.5: p = 0.02, Paired t-test
Retinol Complex 0.5: p = 0.006, Paired t-test
Retinol Complex 0.5: p <0.001, Paired t-test

Population analysed: ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.

Primary outcome: Change From Baseline in Tactile Roughness Score

Time frame: Baseline (Day 1) to Week 12. Mean (Standard Deviation). Unit: score on a scale

Measure	Retinol Complex 0.5 n = 23
Baseline	4.0 (1.7)
Change from BL at Week 12	-1.1 (1.6)

Retinol Complex 0.5: p = 0.002, Paired t-test

Population analysed: ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: First study treatment application up to 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Retinol Complex 0.5	0 of 23 (0%)	12 of 23 (52.2%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Lisa Goberdhan, B.A. principal investigator

Allergan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Retinol Complex 0.5, Facial cleanser and Moisturizing lotion in people with Skin Care, run by Allergan 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 4 Jun 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Overall Photodamage Score (time frame: Baseline (Day 1) to Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03302559.

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 4 Jun 2019.