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

NCT07686198 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: IIT-Rapalogix-2026
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Photodamaged Skin

Keywords

Crepiness; Photodamage; Sun Damage; Arms

Outcome Measures

Primary Outcomes (1)

• Physician Global Aesthetic Improvement Scale (PGAIS):

  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

  Day 84 (Week 14 Post Second Treatment)

Secondary Outcomes (3)

• Participant Global Aesthetic Improvement Scale (SGAIS):

  Day 84 (Week 14 Post Second Treatment)

• 10-point Dermatologic Assessment Form and Photographic Scale

  Screening and Day 84 (Week 14 Post Second Treatment)

• Skin Quality Assessment

  Screening and Day 84 (Week 14 Post Second Treatment)

Study Arms (2)

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.

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.

Drug: Left Arm treated with vehicle serum and Intense Pulsed Light Therapy

Interventions

Right Arm treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light Therapy DRUG

Right Arm treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light Therapy

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 Therapy DRUG

Left Arm treated with vehicle serum and Intense Pulsed Light Therapy

Group B Left Arm Treated with Vehicle serum and Intense Pulsed Light Therapy

Eligibility Criteria

• Age: 50 Years - 80 Years
• Gender Eligibility Details: Female genders tend to have more photodamage than male genders.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead
• Rapalogix: collaborator

Study Sites (1)

West Dermatology Research Center/Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Rhabdomyosarcoma, Alveolar

Interventions

Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Rhabdomyosarcoma; Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Central Study Contacts

Andrea Pacheco

CONTACT

858-657-1004; apacheco@clderm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06

Locations

US (1)