Secretome Treatment for Facial Rejuvenation
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age30-75
SponsorAcorn Biolabs Inc.
About this trial
Secretome treatment for facial rejuvenation
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or Female
Age: ≥30 and ≤ 75 at the time of consent.
Fitzpatrick skin types I-V
Moderate to very severe facial aging according to the SASSQ for the categories of elasticity, wrinkles, and skin roughness.
Disqualifiers
Use of topical tretinoin, adapalene, tazarotene, hydroquinone, imiquimod, 5-fluorouracil, ingenol mebutate, concentrated hydrogen peroxide, diclofenac, vitamin C, alpha hydroxy acids, or photodynamic therapy (PDT) to the face within 4 weeks prior to baseline photography and throughout the study period
Dermatologic diseases or conditions (e.g. atopic dermatitis, psoriasis, rosacea, seborrheic dermatitis, wounds, infections, irritation, sunburn, windburn, etc.) in the treatment area that could interfere with the study, in the opinion of the Investigator
Starting to use or stopping the use of GLP-1 agonists, or planned weight loss or gain during the study period. Subjects using GLP-1 agonists must be taking the drug for maintenance AND body weight must have been stable for at least 3 months prior to initial study treatment.
History of keloid formation, hypertrophic scarring, or abnormal/delayed wound healing
Trial design
Design model
Crossover
Treatments tested in this trial
Autologous Hair Follicle-Derived Secretome
Other interventionThis interventional product is a secretome derived from the stem cells that reside in the hair follicle.
Control Saline
Other interventionSaline solution will be the placebo control. The active is diluted with saline so this is an appropriate control.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: ControlPlacebo comparator 1 intervention
Group B: Active-SecretomeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events
Adverse events and expected treatment effects will be collected at each time point. Spontaneously reported adverse events will also be collected.
Time frame
Baseline to 120days2
VISIA-CR Skin Quality Scores (VISIA-CR is not an acronym, it is a brand name of the system)
VISIA-CR photography and analysis of skin quality (redness, wrinkles, UV spots, skin roughness). Scores range from 0-100. Lower scores are improvement.
Time frame
Baseline, 30, 60, 90 and 120 daysSecondary outcomes
1
Subject Satisfaction
Subject Satisfaction Scale is a 5-point Likert Scale. The scale is Dissatisfied, Neither Satisfied or Dissatisfied, Slightly Satisfied, Satisfied and Very Satisfied.
Time frame
30, 60, 90 and 120 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov