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.
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.
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.
Parallel
Right Arm treated with Active Re-Q Pro-Longevity Serum and Intense Pulsed Light Therapy
DrugRight 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
DrugLeft Arm treated with vehicle serum and Intense Pulsed Light Therapy
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
Participant Global Aesthetic Improvement Scale (SGAIS):
Participant 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
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
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
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Goldman, Butterwick, Fitzpatrick and Groff
Lead sponsor
Rapalogix
Collaborator
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