Facial WrinklesPhase 2/3NCT06638905
Efficacy and Safety of Skincare Serum and Cream for Anti-aging of Facial Skin
A Phase 2/3 study testing Babor Ultimate ECM Repair Serum and Babor Cure Cream in people with Facial Wrinkles and Skin Aging, run by Goldman, Butterwick, Fitzpatrick and Groff.
Trial summary
The primary objective of this study is to assess the efficacy and safety of combination therapy of BABOR® Ultimate ECM Repair Serum and the BABOR® Cure Cream for the improvement of anti-aging through the use of investigator assessments, subject questionnaires/assessments, photography, skin imaging, and reported… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Wrinkles, Skin Aging
- What is being tested?
- Babor Ultimate ECM Repair Serum and Babor Cure Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 28 Oct 2024to 5 May 2025
- Phase
- Phase 2/3
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women between the ages of 18 and 50 years old (inclusive).
- Subjects must be able and willing to provide written informed consent and photography release.
- At the baseline evaluation, all subjects must exhibit mild to moderate skin aging, as defined below (Appendix A):
- Class I-II of Wrinkling on the Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale
- Score 1-6 of Degree of Elastosis on the Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale
- Mild to Moderate on Redness/Erythema Grading Scale
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- Mild to Moderate on Dryness/Scaling/Roughness Grading Scale
- Mild to Moderate on Luminosity Scale
- Subject must be in good general health with no other skin disease, disease state or physical condition which would impair evaluation of the areas to be treated or which would increase the subject's health risk by study participation.
- Subjects must have a willingness to minimize sun exposure, avoid direct sun exposure on the face, and avoid the use of tanning beds for the entire duration of the study. Must be willing to wear a hat and reapply sunscreen if sun exposure is unavoidable.
- Subjects must be willing and able to understand and comply with the requirements of the study including prolonged sun exposure and apply the products as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study
- For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment.
- A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
- Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g., condoms and spermicide), abstinence, and/or vasectomy of partner with a documented second acceptable method of birth control, should the subject become sexually active.
Who cannot join
- Subjects who are pregnant, planning pregnancy during the course of the study, or breastfeeding.
- Subjects with an active bacterial, fungal, or viral infection in the treatment area
- Subjects with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- Subjects receiving any topical products containing tretinoins or derivatives, alpha-hydroxy acids, salicylic acid, and vitamins C or E (includes derivatives thereof) on the face within 14 days prior to or during the study period, other than the study products.
- Subjects receiving a chemical peel, any systemic steroids, a non-ablative laser, ablative laser, microfocused ultrasound, light or radio frequency treatment, deep chemical peel, and/or has had a Dermabrasion on their face must have discontinued the drug/treatment and/or had the procedure at least 6 months prior to entering the study.
- Subjects who have had a microdermabrasion (light or medium skin peel) treatment on their face within 30 days prior to and not willing to refrain from use for the duration of the study period.
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- Subjects with recently excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study or has used self-tanner within 7 days of study entry.
- Subjects that has previously been treated with a systemic retinoid within the past 3 months (e.g., Accutane®, Roche Dermatologics).
- Subjects with a history of keloids or hypertrophic scars.
- Subjects with known allergies to any of the product ingredients.
- Subjects with a tattoo and/or scar in the treatment area that in the investigators opinion would interfere with study assessments.
- Subjects with history of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis) at the discretion of the investigator.
- Inability to comply with all study protocol restrictions and visits.
- Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
- History of non-compliance with clinical research protocols.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Open Label Clinical Study Evaluating the Efficacy and Safety of Skincare Serum and Cream for Anti-aging of Facial Skin
The primary objective of this study is to assess the efficacy and safety of combination therapy of BABOR® Ultimate ECM Repair Serum and the BABOR® Cure Cream for the improvement of anti-aging through the use of investigator assessments, subject questionnaires/assessments, photography, skin imaging, and reported adverse reactions.
Read the detailed description
Enrolled subjects will use a skin care regimen cosisting of BABOR® Ultimate ECM Repair Serum, BABOR® Cure Cream gel, mineral sunscreen, and regeneration cleanser and regeneration toner. Subjects satisfying all inclusion and exclusion criteria will be enrolled in this trial. Prior to receiving any study treatment, mandatory photography using Canfield VISIA imaging and handheld 2D photography. Patients will return for follow-up assessments at Day 30, 60, and 90.
- Conditions
- Facial Wrinkles, Skin Aging
- Being tested
- Babor Ultimate ECM Repair Serum, Babor Cure Cream
- Keywords
- Wrinkles, Face Wrinkles, Cosmetic, Crow's Feet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Babor Ultimate ECM Repair SerumDrug
The BABOR® Ultimate ECM Repair Serum contains Biogen plant extract, cotton thistle flower, and wakame extract. Babor products are encouraged to be used simultaneously mornings and/or evenings to reinforce the skin's protective barrier, promote vibrant skin, and restore skin elasticity and firmness.
Babor Cure CreamDrug
Babor products are encouraged to be used simultaneously mornings and/or evenings to reinforce the skin's protective barrier, promote vibrant skin, and restore skin elasticity and firmness.
| Study group | Role | What they receive |
|---|---|---|
| Babor Products | Experimental | Enrolled subjects will all receive Babor Ultimate ECM Repair Serum and Babor Cure Cream to be applied to their entire face. Receives: Drug: Babor Ultimate ECM Repair Serum; Drug: Babor Cure Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fitzpatrick- Goldman Classification of Wrinkling and Degree of Elastosis Scale
Circle appropriate class:
Class one: Mild Fine Wrinkles 1-2-3
Class two: Moderate Wrinkles 4-5-6
Class three: Severe Wrinkles 7-8-9
Measured: Screening, Day 60, Day 90
Evaluating Investigator Expert Grading Scales
Redness/ Erythema:
None (Score of 0) No erythema or redness of the treatment area Mild (Score of 1, 2 or 3) Slight, but definite redness of the treatment area Moderate (Score of 4, 5 or 6) Definite redness of the treatment area Severe (Score of 7, 8 or 9) Marked redness of the treatment area
Dryness/ Scaling/Roughness:
None (Score of 0) No dryness, roughness, or flaking/scaling of the treatment area Mild (Score of 1, 2 or 3) Slight, but definite roughness, some areas of light visible flaking/scaling of the treatment area Moderate (Score of 4, 5 or 6) Definite roughness and areas of visible flaking/scaling of the treatment area Severe (Score of 7, 8 or 9) Marked roughness and areas of visible flaking/scaling of the treatment area
Measured: Screening, Day 30, Day 60, Day 90
Evaluating Investigator Expert Grading Scales (part 2)
Luminosity:
None (Score of 0) Radiant, luminous or glowing appearance Mild (Score of 1, 2 or 3) Some areas of dullness or matte skin in the treatment area Moderate (Score of 4, 5 or 6) Several areas of dullness or matte skin in the treatment area Severe (Score of 7, 8 or 9) Dull/matte and/or sallow skin appearance
Measured: Screening, Day 30, Day 60, Day 90
Secondary outcomes (5)
Evaluating Investigator Tolerability Assessment
Stinging/ Burning:
None (Score of 0) No stinging/burning of the treatment area Mild (Score of 1, 2 or 3) Slight, but definite stinging/burning of the treatment area Moderate (Score of 4, 5 or 6) Definite stinging/burning of the treatment area Severe (Score of 7, 8 or 9) Marked stinging/burning of the treatment area
Itching:
None (Score of 0) No itching of the treatment area. Mild (Score of 1, 2 or 3) Slight, but definite itching of the treatment area. Moderate (Score of 4, 5 or 6) Definite itching of the treatment area that is distracting from daily activities.
Severe (Score of 7, 8 or 9) Marked itching of the treatment area that wakes you up at night.
Rash:
None (Score of 0) No new rash over the treatment area. Mild (Score of 1, 2 or 3) New rash covering some of the treatment area. Moderate (Score of 4, 5 or 6) New rash covering much of the treatment area. Severe (Score of 7, 8 or 9) New rash covering the entirety of the treatment area.
Measured: Screening, Day 30, Day 60, Day 90
Subject Self-Assessment Questionnaire (part 1)
- Skincare regimen helps reduce the wrinkles of my facial skin. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
- Skincare regimen helps reduce the dryness of my facial skin. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
- Cleanser/moisturizer regimen helps decrease the dullness of my facial skin. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
- Skincare regimen helps reduce the unevenness of my facial skin. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
- Skincare regimen leaves my facial skin radiant/brighter. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
Measured: Screening, Day 30, Day 60, Day 90
Subject Self-Assessment Questionnaire (part 2)
- Skincare regimen leaves my facial skin softer. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 7. Skincare regimen leaves my facial skin smoother. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 8. Skincare regimen is gentle. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 9. Skincare regimen leaves my facial skin healthy looking. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 10. Skincare regimen helps reduce the flakiness of my skin. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
Measured: Screening, Day 30, Day 60, Day 90
Subject Self-Assessment Questionnaire (part 3)
- I now understand the importance of a consistent skincare routine. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 12. I feel more confident about the appearance of my facial skin. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 13. Using this skincare regimen makes me optimistic about my appearance. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 14. This skincare regimen was easy to follow. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 15. It was easy to adhere to this skincare routine. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
Measured: Screening, Day 30, Day 60, Day 90
Subject Self-Assessment Questionnaire (part 4)
- Using these products did not irritate my skin. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 17. The results I received made me want to continue this skincare routine. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 18. I was able to easily commit to this routine due to its simplicity. Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly 19. Please include further comments regarding your experience with these products.
Agree Strongly Agree Neither agree nor disagree Disagree Disagree Strongly
Measured: Screening, Day 30, Day 60, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start28 Oct 2024 (estimated)
- Primary completion5 Mar 2025 (estimated)
- Study completion5 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial WrinklesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will be treated with a combination therapy of Babor Ultimate ECM Repair Serum and the Babor Cure Cream to their entire face.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Collaborators
- Babor Americas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638905
- Sponsor's protocol ID
- Babor-2024
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 15 Oct 2024
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label Clinical Study Evaluating the Efficacy and Safety of Skincare Serum and Cream for Anti-aging of Facial Skin
- ClinicalTrials.gov ID
- NCT06638905
- Acronym / sponsor ID
- Babor-2024
- Conditions
- Facial Wrinkles, Skin Aging
- Keywords
- Wrinkles, Face Wrinkles, Cosmetic, Crow's Feet
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Collaborators
- Babor Americas
- Study start
- 28 Oct 2024 (estimated)
- Primary completion
- 5 Mar 2025 (estimated)
- Study completion
- 5 May 2025 (estimated)
- First posted
- 15 Oct 2024 (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.
The primary objective of this study is to assess the efficacy and safety of combination therapy of BABOR® Ultimate ECM Repair Serum and the BABOR® Cure Cream for the improvement of anti-aging through the use of investigator assessments, subject questionnaires/assessments, photography, skin imaging, and reported adverse reactions.
Detailed description
Enrolled subjects will use a skin care regimen cosisting of BABOR® Ultimate ECM Repair Serum, BABOR® Cure Cream gel, mineral sunscreen, and regeneration cleanser and regeneration toner. Subjects satisfying all inclusion and exclusion criteria will be enrolled in this trial. Prior to receiving any study treatment, mandatory photography using Canfield VISIA imaging and handheld 2D photography. Patients will return for follow-up assessments at Day 30, 60, and 90.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will be treated with a combination therapy of Babor Ultimate ECM Repair Serum and the Babor Cure Cream to their entire face.
| Arm | Type | Receives |
|---|---|---|
| Babor Products | Experimental | Drug: Babor Ultimate ECM Repair Serum, Drug: Babor Cure CreamEnrolled subjects will all receive Babor Ultimate ECM Repair Serum and Babor Cure Cream to be applied to their entire face. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Men and women between the ages of 18 and 50 years old (inclusive).
- Subjects must be able and willing to provide written informed consent and photography release.
- At the baseline evaluation, all subjects must exhibit mild to moderate skin aging, as defined below (Appendix A):
- Subject must be in good general health with no other skin disease, disease state or physical condition which would impair evaluation of the areas to be treated or which would increase the subject's health risk by study participation.
- Subjects must have a willingness to minimize sun exposure, avoid direct sun exposure on the face, and avoid the use of tanning beds for the entire duration of the study. Must be willing to wear a hat and reapply sunscreen if sun exposure is unavoidable.
Key exclusion criteria (15 listed)
- Subjects who are pregnant, planning pregnancy during the course of the study, or breastfeeding.
- Subjects with an active bacterial, fungal, or viral infection in the treatment area
- Subjects with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- Subjects receiving any topical products containing tretinoins or derivatives, alpha-hydroxy acids, salicylic acid, and vitamins C or E (includes derivatives thereof) on the face within 14 days prior to or during the study period, other than the study products.
- Subjects receiving a chemical peel, any systemic steroids, a non-ablative laser, ablative laser, microfocused ultrasound, light or radio frequency treatment, deep chemical peel, and/or has had a Dermabrasion on their face must have discontinued the drug/treatment and/or had the procedure at least 6 months prior to entering 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 |
|---|---|---|
| Babor Ultimate ECM Repair SerumThe BABOR® Ultimate ECM Repair Serum contains Biogen plant extract, cotton thistle flower, and wakame extract. Babor products are encouraged to be used simultaneously mornings and/or evenings to reinforce the skin's protective barrier, promote vibrant skin, and restore skin elasticity and firmness. | Drug | Babor Products |
| Babor Cure CreamBabor products are encouraged to be used simultaneously mornings and/or evenings to reinforce the skin's protective barrier, promote vibrant skin, and restore skin elasticity and firmness. | Drug | Babor Products |
Primary outcome
Fitzpatrick- Goldman Classification of Wrinkling and Degree of Elastosis Scale
Time frame: Screening, Day 60, Day 90
Circle appropriate class: Class one: Mild Fine Wrinkles 1-2-3 Class two: Moderate Wrinkles 4-5-6 Class three: Severe Wrinkles 7-8-9
Evaluating Investigator Expert Grading Scales
Time frame: Screening, Day 30, Day 60, Day 90
Redness/ Erythema: None (Score of 0) No erythema or redness of the treatment area Mild (Score of 1, 2 or 3) Slight, but definite redness of the treatment area Moderate (Score of 4, 5 or 6) Definite redness of the treatment area Severe (Score of 7, 8 or 9) Marked redness of the treatment area Dryness/ Scaling/Roughness: None (Score of 0) No dryness, roughness, or flaking/scaling of the treatment area Mild (Score of 1, 2 or 3) Slight, but definite roughness, some areas of light visible flaking/scaling of the treatment area Moderate (Score of 4, 5 or 6) Definite roughness and areas of visible flaking/scaling of the treatment area Severe (Score of 7, 8 or 9) Marked roughness and areas of visible flaking/scaling of the treatment area
Evaluating Investigator Expert Grading Scales (part 2)
Time frame: Screening, Day 30, Day 60, Day 90
Luminosity: None (Score of 0) Radiant, luminous or glowing appearance Mild (Score of 1, 2 or 3) Some areas of dullness or matte skin in the treatment area Moderate (Score of 4, 5 or 6) Several areas of dullness or matte skin in the treatment area Severe (Score of 7, 8 or 9) Dull/matte and/or sallow skin appearance
5 secondary outcomes
Evaluating Investigator Tolerability Assessment
Time frame: Screening, Day 30, Day 60, Day 90
Subject Self-Assessment Questionnaire (part 1)
Time frame: Screening, Day 30, Day 60, Day 90
Subject Self-Assessment Questionnaire (part 2)
Time frame: Screening, Day 30, Day 60, Day 90
Subject Self-Assessment Questionnaire (part 3)
Time frame: Screening, Day 30, Day 60, Day 90
Subject Self-Assessment Questionnaire (part 4)
Time frame: Screening, Day 30, Day 60, Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Babor Ultimate ECM Repair Serum and Babor Cure Cream in people with Facial Wrinkles and Skin Aging, run by Goldman, Butterwick, Fitzpatrick and Groff.
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 14 inclusion and 15 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Andrea Pacheco (858-657-1004, apacheco@clderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fitzpatrick- Goldman Classification of Wrinkling and Degree of Elastosis Scale (time frame: Screening, Day 60, Day 90). The study lists 3 primary outcomes in all. 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 15 Oct 2024.