Study Comparing Two Serums With Intense Pulsed Light for the Treatment of Moderate to Severe Photodamage and Crepiness on the Forearms

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Photodamaged Skin
• Intervention / Treatment: Drug: Right Arm treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light Therapy; Drug: Left Arm treated with vehicle serum and Intense Pulsed Light Therapy

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Andrea Pacheco; Phone Number: 858-657-1004; Email: apacheco@clderm.com

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • West Dermatology Research Center/Cosmetic Laser Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Female participants aged 50 to 80 years.
2. Fitzpatrick skin types I-IV.
3. 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
4. Willing and able to comply with all study requirements, including scheduled visits, treatment protocol, and follow-up assessments.
5. Willing to sign an informed consent form and photography release for research, publication, and/or commercial use.
6. In good general health as determined by the investigator based on medical history and clinical judgment.
7. Willing to maintain the study skincare regimen and refrain from introducing new topical or procedural treatments to the forearms during the study period.
8. Negative urine pregnancy test at all visits for participants of childbearing potential.
9. 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)

Exclusion Criteria:

1. 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
2. A suntan in the treatment area or use of sunless tanner/spray-tan in the treatment areas 4 weeks prior to study treatment
3. Active infection, open wounds, or inflammatory dermatoses (e.g., eczema, psoriasis, dermatitis) in the treatment area.
4. 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.
5. Use of GLP-1 medications or metformin within 3 months prior to enrollment
6. Pregnancy, plans to become pregnant during the study period, or current breastfeeding.
7. History of autoimmune connective tissue diseases (e.g., systemic lupus erythematosus, scleroderma, dermatomyositis).
8. Current or recent use (within the past 3 months) of systemic immunosuppressive medications.
9. 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.
10. 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.
11. Active smoking tobacco or use of nicotine-containing products within 6 months prior to enrollment.
12. Participation in any other interventional clinical study within 30 days prior to enrollment or during the course of this study.
13. 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.
14. History of keloids or scarring/tattoos in the treatment area

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A Right Arm Treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light Therapy; 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.	Drug: Right Arm treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light Therapy; Right Arm treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light Therapy
Sham Comparator: Group B Left Arm Treated with Vehicle serum and Intense Pulsed Light Therapy; 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.	Drug: Left Arm treated with vehicle serum and Intense Pulsed Light Therapy; Left Arm treated with vehicle serum and Intense Pulsed Light Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 84 (Week 14 Post Second Treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	Screening and Day 84 (Week 14 Post Second Treatment)

Collaborators and Investigators

• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff
• Collaborators: Rapalogix

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2026
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: June 30, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Photodamage; Sun Damage; Arms; Crepiness
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms, Muscle Tissue; Myosarcoma; Rhabdomyosarcoma; Rhabdomyosarcoma, Alveolar; Therapeutics; Phototherapy; Intense Pulsed Light Therapy
• Other Study ID Numbers: IIT-Rapalogix-2026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes