Facial PhotodamageNCT03559972
Study to Evaluate Efficacy and Tolerability of Two Topical Regimens in Subjects With Moderate to Severe Facial Photodamage Who Have Received Cosmetic Injections
A study testing on-label facial injection in people with Facial Photodamage, run by Allergan at 2 sites in United States.
Trial summary
This study will assess the efficacy and tolerability of two topical regimens (containing cosmetic human fibroblast-derived, physiologically-balanced growth factor combination products (HULK and TNS Essential Serum) Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Facial Photodamage
- What is being tested?
- on-label facial injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Jun 2018to 3 Dec 2018
- Phase
- Interventional
- 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 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects aged 30 years and older with Fitzpatrick skin type I-VI
- Pre-elected to receive on-label facial injection(s) (i.e. neuromodulator injection and/or filler injections)
- Experienced injection patients defined as having received at least 1 facial injection in the past 2 years.
- Current users of non-physician-dispensed brand skin care products (i.e. only using products that are available at drugstores or department stores
- Good general health and free of any disease state or physical condition (e.g. psoriasis, rosacea, scars, tattoos etc.)
- Willingness to have exams and digital photos performed on the face.
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- Willingness to cooperate and participate by following study requirements (including using the provided test products) for the duration of the study and to report any adverse event symptoms or reactions immediately.
- Willingness to discontinue use of their current skincare products starting at their Week 4 visit in this study.
- Willingness to not use any other products, including self-tanners, on their face for the duration of the study other than make-up with an established tolerance of at least 1 month.
- Willingness to withhold all facial treatments during the course of the study including microdermabrasion, peels, facials, laser treatments and tightening treatments.
- .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. Subjects are asked to wear protective clothing prior to and during exposure.
- If of child-bearing potential, willing to use an acceptable method of contraception throughout the study. Acceptable methods of birth
Who cannot join
- Who are nursing, pregnant, or planning to become pregnant during the study according to subject self-report.
- 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.
- Uncontrolled disease such as diabetes, hypertension, hyper or hypo-thyroidism, 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 conduct of the study.
- Individuals with any planned surgeries and/or invasive medical procedures during the course of the study
- Individuals who are currently participating in any other facial usage study or have participated in any clinical trial within 4 weeks prior to inclusion of the study.
- Subjects currently on or planning to participate on any type of research study at another facility or a doctor's office during this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Suzanne Bruce and Associates, PA, The Center for Skin Research
Houston, Texas, 77056
Cosmetic Laser Dermatology
San Diego, California, 92121
About this study
Official title: Open-Label, Randomized, Multi-center Study to Evaluate the Efficacy and Tolerability of Two Topical Regimens in Subjects With Moderate to Severe Facial Photodamage Who Have Received Cosmetic Injections
This study will assess the efficacy and tolerability of two topical regimens (containing cosmetic human fibroblast-derived, physiologically-balanced growth factor combination products (HULK and TNS Essential Serum)
- Conditions
- Facial Photodamage
- Being tested
- on-label facial injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
on-label facial injectionOther
Assessing if adding SkinMedica's cosmetic topical skincare regimens improves the appearance of the skin and the subject's experience, when used after pre-elected on-label facial injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group #1 | Experimental | Subject in Treatment group 1 will apply the following products in the morning and evening.
1. SkinMedica Facial Cleanser
2. Hulk (cosmetic investigational)
3. Marvel AM (cosmetic investigational)
4. Marvel PM (cosmetic investigational)
5. SkinMedica HA5 Rejuvenating Hydrator
6. SkinMedica Rejuvenative Moisturizer
7. SkinMedica Essential Defense Mineral Shield SPF 35 Sunscreen Receives: Other: on-label facial injection |
| Treatment group #2 | Experimental | Subject in Treatment group 2 will apply the following products in the morning and evening.
1. SkinMedica Facial Cleanser
2. SkinMedica TNS Essential Serum
3. Marvel AM (cosmetic investigational)
4. Marvel PM (cosmetic investigational)
5. SkinMedica HA5 Rejuvenating Hydrator
6. SkinMedica Rejuvenative Moisturizer
7. SkinMedica Essential Defense Mineral Shield SPF 35 Sunscreen Receives: Other: on-label facial injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Clinical grading of the full face on the Griffith's modified 10-point scale
Investigator will assess the following parameters on a Griffith's modified 10-point scale (0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, 7 to 9 = Severe)
Measured: Baseline, Week 4, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start4 Jun 2018
- Primary completion3 Dec 2018
- Study completion3 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial PhotodamageStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Makino, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559972
- Sponsor's protocol ID
- SKM18-HULK-INJ
- Status last verified
- Jan 2019
- First submitted
- 23 May 2018
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Randomized, Multi-center Study to Evaluate the Efficacy and Tolerability of Two Topical Regimens in Subjects With Moderate to Severe Facial Photodamage Who Have Received Cosmetic Injections
- ClinicalTrials.gov ID
- NCT03559972
- Acronym / sponsor ID
- SKM18-HULK-INJ
- Conditions
- Facial Photodamage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 3 Dec 2018 (actual)
- First posted
- 18 Jun 2018 (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 study will assess the efficacy and tolerability of two topical regimens (containing cosmetic human fibroblast-derived, physiologically-balanced growth factor combination products (HULK and TNS Essential Serum)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group #1 | Experimental | Other: on-label facial injectionSubject in Treatment group 1 will apply the following products in the morning and evening. 1. SkinMedica Facial Cleanser 2. Hulk (cosmetic investigational) 3. Marvel AM (cosmetic investigational) 4. Marvel PM (cosmetic investigational) 5. SkinMedica HA5 Rejuvenating Hydrator 6. SkinMedica Rejuvenative Moisturizer 7. SkinMedica Essential Defense Mineral Shield SPF 35 Sunscreen |
| Treatment group #2 | Experimental | Other: on-label facial injectionSubject in Treatment group 2 will apply the following products in the morning and evening. 1. SkinMedica Facial Cleanser 2. SkinMedica TNS Essential Serum 3. Marvel AM (cosmetic investigational) 4. Marvel PM (cosmetic investigational) 5. SkinMedica HA5 Rejuvenating Hydrator 6. SkinMedica Rejuvenative Moisturizer 7. SkinMedica Essential Defense Mineral Shield SPF 35 Sunscreen |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female subjects aged 30 years and older with Fitzpatrick skin type I-VI
- Pre-elected to receive on-label facial injection(s) (i.e. neuromodulator injection and/or filler injections)
- Experienced injection patients defined as having received at least 1 facial injection in the past 2 years.
- Current users of non-physician-dispensed brand skin care products (i.e. only using products that are available at drugstores or department stores
- Good general health and free of any disease state or physical condition (e.g. psoriasis, rosacea, scars, tattoos etc.)
Key exclusion criteria (8 listed)
- Who are nursing, pregnant, or planning to become pregnant during the study according to subject self-report.
- 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.
- Uncontrolled disease such as diabetes, hypertension, hyper or hypo-thyroidism, 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 conduct of 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 |
|---|---|---|
| on-label facial injectionAssessing if adding SkinMedica's cosmetic topical skincare regimens improves the appearance of the skin and the subject's experience, when used after pre-elected on-label facial injection | Other | Treatment Group #1, Treatment group #2 |
Primary outcome
Change from Baseline in Clinical grading of the full face on the Griffith's modified 10-point scale
Time frame: Baseline, Week 4, Week 16
Investigator will assess the following parameters on a Griffith's modified 10-point scale (0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, 7 to 9 = Severe)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistanceLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Facial Photodamage
Not yet recruiting
Evaluation of the Efficacy and Tolerability of the LED Mask With or Without the Serum Formula on the Signs of Facial Photodamage .
Photodamage of the Face, Anti Aging
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.
Elizabeth Makino study director
Allergan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing on-label facial injection in people with Facial Photodamage, run by Allergan at 2 sites 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 8 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 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Clinical grading of the full face on the Griffith's modified 10-point scale (time frame: Baseline, Week 4, Week 16). 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 30 Jan 2019.