Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Rapalogix | UNKNOWN |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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)
| Day 84 (Week 14 Post Second Treatment) |
| 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)
| Day 84 (Week 14 Post Second Treatment) |
| 10-point Dermatologic Assessment Form and Photographic Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Female genders tend to have more photodamage than male genders.
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Pacheco | Contact | 858-657-1004 | apacheco@clderm.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Dermatology Research Center/Cosmetic Laser Dermatology | San Diego | California | 92121 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| Left Arm treated with vehicle serum and Intense Pulsed Light Therapy | Drug | Left Arm treated with vehicle serum and Intense Pulsed Light Therapy |
|
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) |
| ID | Term |
|---|---|
| D018232 | Rhabdomyosarcoma, Alveolar |
| ID | Term |
|---|---|
| D012208 | Rhabdomyosarcoma |
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
Not provided
Not provided
| ID | Term |
|---|---|
| D062325 | Intense Pulsed Light Therapy |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
Not provided
Not provided