Photodamaged SkinPhase 2/3NCT07686198
Study Comparing Two Serums With Intense Pulsed Light for the Treatment of Moderate to Severe Photodamage and Crepiness on the Forearms
A Phase 2/3 study testing Right Arm treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light Therapy in people with Photodamaged Skin, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial summary
The primary objective is to compare Re-Q Pro-Longevity serum versus vehicle serum combined with Intense Pulsed Laser for the treatment of moderate to severe photodamage and crepiness on the dorsal forearms. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Photodamaged Skin
- What is being tested?
- Right Arm treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2026to 30 Jan 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female participants aged 50 to 80 years.
- Fitzpatrick skin types I-IV.
- Moderate to severe photodamage and crepiness on the arms, based on clinical evaluation, including fine wrinkling, coarse wrinkling, photodamage, and a global assessment as assessed with the 10-point Dermatologic Assessment Form and Photographic Scale
- Willing and able to comply with all study requirements, including scheduled visits, treatment protocol, and follow-up assessments.
- Willing to sign an informed consent form and photography release for research, publication, and/or commercial use.
- In good general health as determined by the investigator based on medical history and clinical judgment.
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- Willing to maintain the study skincare regimen and refrain from introducing new topical or procedural treatments to the forearms during the study period.
- Negative urine pregnancy test at all visits for participants of childbearing potential.
- Participants must be of non-childbearing potential, defined as: a. History of hysterectomy or bilateral oophorectomy, or b. No menses for at least 12 consecutive months without an alternative medical cause. Or, if of childbearing potential, must agree to use an effective form of contraception during the course of the study. Acceptable methods include: i. Oral contraceptive pill, injection, implant, patch, vaginal ring, or intrauterine device (IUD) ii. Intrauterine coil iii. Bilateral tubal ligation iv. Hysterectomy v. Barrier method used with an additional form of contraception (e.g., spermicide, sponge, or condom) vi. Abstinence (must agree to use a barrier method if sexual activity begins during the study) vii. Partner with a vasectomy (if not, participant must agree to use a barrier method)
Who cannot join
- Patients with dark hair in the treatment area who are unwilling to shave the treated area prior to IPL treatments or who are unwilling to proceed knowing IPL will eliminate at least 50% of the hairs in the treatment area
- A suntan in the treatment area or use of sunless tanner/spray-tan in the treatment areas 4 weeks prior to study treatment
- Active infection, open wounds, or inflammatory dermatoses (e.g., eczema, psoriasis, dermatitis) in the treatment area.
- Use of at-home energy-based devices intended for rejuvenation or fibroblastic/collagen stimulation on the treatment area within 30 days prior to treatment and during the study period.
- Use of GLP-1 medications or metformin within 3 months prior to enrollment
- Pregnancy, plans to become pregnant during the study period, or current breastfeeding.
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- History of autoimmune connective tissue diseases (e.g., systemic lupus erythematosus, scleroderma, dermatomyositis).
- Current or recent use (within the past 3 months) of systemic immunosuppressive medications.
- Any uncontrolled systemic condition that may increase risk or interfere with study participation, including but not limited to poorly managed diabetes, thyroid dysfunction, or cardiovascular disease.
- Clinically significant neurological, psychological or psychiatric conditions, or any condition that, in the opinion of the investigator, may interfere with study participation or interpretation of results.
- Active smoking tobacco or use of nicotine-containing products within 6 months prior to enrollment.
- Participation in any other interventional clinical study within 30 days prior to enrollment or during the course of this study.
- Unwillingness to refrain from undergoing any additional aesthetic treatments to the arms (e.g., lasers, injectables, energy-based devices, cosmeceuticals, etc.) from screening through the end of the study period.
- History of keloids or scarring/tattoos in the treatment area
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
West Dermatology Research Center/Cosmetic Laser Dermatology
San Diego, California, 92121
About this study
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Split-Arm Study of Twice Daily Re-Q Pro-Longevity Serum in Combination With Intense Pulsed Light for the Treatment of Moderate to Severe Photodamage and Crepiness on the Forearms
The primary objective is to compare Re-Q Pro-Longevity serum versus vehicle serum combined with Intense Pulsed Laser for the treatment of moderate to severe photodamage and crepiness on the dorsal forearms.
Read the detailed description
This is a randomized, double-blind, split-arm study consisting of twenty (20) adult participants with moderate to severe photodamage and crepiness on the dorsal forearms. Participants who sign consent and meet all inclusion criteria and none of the exclusion criteria will be enrolled. Respective arms will be randomized to receive 2 weeks of pre-treatment either with Re-Q Pro-Longevity Serum on one arm and vehicle serum on the other arm. Participants will apply the study product to the bilateral dorsal forearms after facial cleansing every morning and evening. The participants will return back to the site at week 2 (days 0) for second visit. Participants will receive first IPL treatment from the dorsal hands to the elbows.
- Conditions
- Photodamaged Skin
- Being tested
- Right Arm treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light Therapy, Left Arm treated with vehicle serum and Intense Pulsed Light Therapy
- Keywords
- Crepiness, Photodamage, Sun Damage, Arms
- Medical subject headings
- Rhabdomyosarcoma, Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right Arm treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light TherapyDrug
Right Arm treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light Therapy
Left Arm treated with vehicle serum and Intense Pulsed Light TherapyDrug
Left Arm treated with vehicle serum and Intense Pulsed Light Therapy
| Study group | Role | What they receive |
|---|---|---|
| Group A Right Arm Treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light Therapy | Active comparator | Subjects will pre-treat for two weeks with the active serum, then return to office for the first IPL treatment. They will continue to use the serum and return four weeks later for the second IPL treatment. Receives: Drug: Right Arm treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light Therapy |
| Group B Left Arm Treated with Vehicle serum and Intense Pulsed Light Therapy | Sham comparator | Subjects will pre-treat for two weeks with the active serum, then return to office for the first IPL treatment. They will continue to use the serum and return four weeks later for the second IPL treatment. Receives: Drug: Left Arm treated with vehicle serum and Intense Pulsed Light Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Global Aesthetic Improvement Scale (PGAIS):
Physician assessed aesthetic improvement. All assessments will be made on 5-point scale (Circle One)
- Very much improved
- Much improved
- Improved
- No change
- Worse
Measured: Day 84 (Week 14 Post Second Treatment)
Secondary outcomes (3)
Participant Global Aesthetic Improvement Scale (SGAIS):
Participant assessed aesthetic improvement. All assessments will be made on 5-point scale (Circle One)
- Very much improved
- Much improved
- Improved
- No change
- Worse
Measured: Day 84 (Week 14 Post Second Treatment)
10-point Dermatologic Assessment Form and Photographic Scale
Physician Assessed : (Circle One)
Fine Wrinkling 0= Absent 1-2-3 = Mild 4-5-6 = Moderate 7-8-9 = Severe
Coarse Wrinkling 0= Absent 1-2-3 = Mild 4-5-6 = Moderate 7-8-9 = Severe
Abnormal Pigmentation 0= Absent 1-2-3 = Mild 4-5-6 = Moderate 7-8-9 = Severe
Global 0= Absent 1-2-3 = Mild 4-5-6 = Moderate 7-8-9 = Severe
Measured: Screening and Day 84 (Week 14 Post Second Treatment)
Skin Quality Assessment
Physician Assessed Skin Quality Assessment (SQS) Grading System (5-point scale) Circle One:
Grade 0 - Excellent • Smooth, even skin • Firm and elastic • No visible crepiness or fine lines • Well-hydrated, healthy appearance
Grade 1 - Good • Mild textural irregularity • Very subtle fine lines or early crepiness • Good firmness with minimal laxity • Overall youthful appearance
Grade 2 - Fair • Noticeable texture changes • Early crepey appearance, especially with movement or pinching • Mild laxity or loss of elasticity • Skin may appear thinner or less hydrated
Grade 3 - Poor • Obvious crepiness at rest • Moderate laxity • Fine lines clearly visible • Uneven surface texture and reduced resilience
Grade 4 - Very Poor • Severe crepiness • Marked laxity and thinning • Prominent fine wrinkling • Dull, fragile, or atrophic appearance
Measured: Screening and Day 84 (Week 14 Post Second Treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion10 Nov 2026 (estimated)
- Study completion30 Jan 2027 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Collaborators
- Rapalogix
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686198
- Sponsor's protocol ID
- IIT-Rapalogix-2026
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Vehicle-Controlled, Split-Arm Study of Twice Daily Re-Q Pro-Longevity Serum in Combination With Intense Pulsed Light for the Treatment of Moderate to Severe Photodamage and Crepiness on the Forearms
- ClinicalTrials.gov ID
- NCT07686198
- Acronym / sponsor ID
- IIT-Rapalogix-2026
- Conditions
- Photodamaged Skin
- Keywords
- Crepiness, Photodamage, Sun Damage, Arms
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Collaborators
- Rapalogix
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 7 Jul 2026 (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 is to compare Re-Q Pro-Longevity serum versus vehicle serum combined with Intense Pulsed Laser for the treatment of moderate to severe photodamage and crepiness on the dorsal forearms.
Detailed description
This is a randomized, double-blind, split-arm study consisting of twenty (20) adult participants with moderate to severe photodamage and crepiness on the dorsal forearms. Participants who sign consent and meet all inclusion criteria and none of the exclusion criteria will be enrolled. Respective arms will be randomized to receive 2 weeks of pre-treatment either with Re-Q Pro-Longevity Serum on one arm and vehicle serum on the other arm. Participants will apply the study product to the bilateral dorsal forearms after facial cleansing every morning and evening. The participants will return back to the site at week 2 (days 0) for second visit. Participants will receive first IPL treatment from the dorsal hands to the elbows.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Right Arm Treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light Therapy | Active comparator | Drug: Right Arm treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light TherapySubjects will pre-treat for two weeks with the active serum, then return to office for the first IPL treatment. They will continue to use the serum and return four weeks later for the second IPL treatment. |
| Group B Left Arm Treated with Vehicle serum and Intense Pulsed Light Therapy | Sham comparator | Drug: Left Arm treated with vehicle serum and Intense Pulsed Light TherapySubjects will pre-treat for two weeks with the active serum, then return to office for the first IPL treatment. They will continue to use the serum and return four weeks later for the second IPL treatment. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female participants aged 50 to 80 years.
- Fitzpatrick skin types I-IV.
- Moderate to severe photodamage and crepiness on the arms, based on clinical evaluation, including fine wrinkling, coarse wrinkling, photodamage, and a global assessment as assessed with the 10-point Dermatologic Assessment Form and Photographic Scale
- Willing and able to comply with all study requirements, including scheduled visits, treatment protocol, and follow-up assessments.
- Willing to sign an informed consent form and photography release for research, publication, and/or commercial use.
Key exclusion criteria (14 listed)
- Patients with dark hair in the treatment area who are unwilling to shave the treated area prior to IPL treatments or who are unwilling to proceed knowing IPL will eliminate at least 50% of the hairs in the treatment area
- A suntan in the treatment area or use of sunless tanner/spray-tan in the treatment areas 4 weeks prior to study treatment
- Active infection, open wounds, or inflammatory dermatoses (e.g., eczema, psoriasis, dermatitis) in the treatment area.
- Use of at-home energy-based devices intended for rejuvenation or fibroblastic/collagen stimulation on the treatment area within 30 days prior to treatment and during the study period.
- Use of GLP-1 medications or metformin within 3 months prior to enrollment
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 |
|---|---|---|
| Right Arm treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light TherapyRight Arm treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light Therapy | Drug | Group A Right Arm Treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light Therapy |
| Left Arm treated with vehicle serum and Intense Pulsed Light TherapyLeft Arm treated with vehicle serum and Intense Pulsed Light Therapy | Drug | Group B Left Arm Treated with Vehicle serum and Intense Pulsed Light Therapy |
Primary outcome
Physician Global Aesthetic Improvement Scale (PGAIS):
Time frame: Day 84 (Week 14 Post Second Treatment)
Physician assessed aesthetic improvement. All assessments will be made on 5-point scale (Circle One) 1. Very much improved 2. Much improved 3. Improved 4. No change 5. Worse
3 secondary outcomes
Participant Global Aesthetic Improvement Scale (SGAIS):
Time frame: Day 84 (Week 14 Post Second Treatment)
10-point Dermatologic Assessment Form and Photographic Scale
Time frame: Screening and Day 84 (Week 14 Post Second Treatment)
Skin Quality Assessment
Time frame: Screening and Day 84 (Week 14 Post Second Treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Right Arm treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light Therapy in people with Photodamaged Skin, 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 9 inclusion and 14 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: opening soon, as of the sponsor's last update on 7 Jul 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Physician Global Aesthetic Improvement Scale (PGAIS): (time frame: Day 84 (Week 14 Post Second Treatment)). 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 7 Jul 2026.