A study testing whether collagen powder helps improve skin
| ISRCTN | ISRCTN54143120 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54143120 |
| Secondary identifying numbers | SGS Stephens, Inc, number: C22-D090, protocol number: Pro00063299 |
- Submission date
- 28/08/2025
- Registration date
- 01/09/2025
- Last edited
- 01/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Dietary consumption of food supplements has been found to modulate skin functions and can therefore be useful in the treatment of skin aging. Prior studies have demonstrated that oral intake of bioactive collagen peptides can reduce skin wrinkles, improve skin elasticity, and have positive effects on dermal matrix synthesis. This study was conducted to assess the effect on facial skin appearance of a collagen powder supplement when consumed daily for 8 weeks by women with mild to moderate periocular fine lines and wrinkles, and fine lines, wrinkles, sagging, and lack of radiance on the global face.
Who can participate?
Adult female healthy volunteers aged over 45 years
What does the study involve?
Participants were randomly assigned to either a dummy (placebo) supplement group or a collagen supplement group. Participants consumed the assigned supplement once per day. The participants were instructed to stir one scoop (2.6g) of the test product into a hot or cold beverage and consume, once daily. They could take the product at any time of the day, before or with food. They stored the products in a cool, dry place that is away from direct heat and light (including sunlight) and protected from contamination.
They were also instructed to wash their face with the provided cleanser as they normally would, and not to use the cleanser if they normally don’t wash their face with anything except water. Once daily, they could apply a sufficient amount of the provided moisturizer to the entire face. But they were instructed not to apply the moisturizer within 24 hours before a clinic visit.
What are the possible benefits and risks of participating?
Benefits
The primary anticipated benefit of this intervention is improved skin health. Collagen supplementation has been associated with enhancements in skin hydration, elasticity, and overall appearance in prior studies. Participants may therefore experience modest but measurable improvements in dermatological outcomes during the course of the trial.
Risks
The risks of participation are expected to be minimal. Collagen is generally recognized as safe, and adverse events are uncommon and typically mild (e.g., transient gastrointestinal discomfort). No serious risks are anticipated. Participants may not personally experience any benefit, but the knowledge gained from the study could contribute to a better scientific understanding of collagen’s role in skin health.
Where is the study run from?
Wellness Discovery Labs, USA. Data was collected at SGS Stephens, Inc, Dallas Research Center, USA.
When is the study starting and how long is it expected to run for?
May 2022 to August 2022
Who is funding the study?
Specnova LLC, USA.
Who is the main contact?
Irina Lorenzi, irina@specnova.com
Contact information
Public, Scientific, Principal Investigator
Wellness Discovery Labs
3535 Pine St
Jacksonville
32205
United States of America
 ORCID ID |
0000-0002-0127-9184 |
|---|---|
| Phone | +1 9048919746 |
| hhausenblas@wellnessdiscoverylabs.com |
Study information
| Study design | Double-blind randomized placebo-controlled clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Internet/virtual, Laboratory, Telephone |
| Study type | Efficacy |
| Scientific title | A double-blind, placebo-controlled clinical study to assess the skin benefits of a collagen powder supplement |
| Study objectives | This single-center, double-blind, randomized, placebo-controlled clinical trial was conducted for Specnova LLC to assess the effect on facial skin appearance of the Sponsor’s collagen powder supplement when consumed daily for 8 weeks by women with mild to moderate periocular fine lines and wrinkles, and fine lines, wrinkles, sagging, and lack of radiance on the global face. |
| Ethics approval(s) |
Approved 03/05/2022, Advarra Institutional Review Board (6100 Merriweather Drive, Suite 600, Maryland, 21044, United States of America; +1 410‑884‑2900; institutions@advarra.com), ref: IRB#00000971 |
| Health condition(s) or problem(s) studied | Assess the effect on facial skin appearance of the collagen powder supplement when consumed daily for 8 weeks by women with mild to moderate periocular fine lines and wrinkles, and fine lines, wrinkles, sagging, and lack of radiance on the global face. |
| Intervention | The research team and study participants were blinded to the treatment assignment and were not made aware of receiving the placebo or the active product. Before the start of the study, SGS Stephens generated a randomization list to establish treatment assignment to 1 of the treatment cells (cell 1 or cell 2). The list was first created by concatenating blocks of size 4 subjects: 2 for cell 1 and 2 for cell 2. The list was then randomized by variables from 2 independent uniform distributions: one to randomize subjects. Within a block and one to randomize blocks. After the randomization list was created, treatment was assigned to each subject number accordingly. During the course of the study, subjects consumed the assigned supplement once per day as directed. The participants were instructed to stir one scoop (2.6g) of the test product into a hot or cold beverage and consume, once daily. They could take the product at any time of the day, before or with food. They stored the products in a cool, dry place that is away from direct heat and light (including sunlight) and protected from contamination. Additionally, all subjects used the supporting materials (Gentle Skin Cleanser and Daily Facial Moisturizer with Sunscreen Broad Spectrum SPF 15) as directed. At week 1, a clinic staff member called each subject to confirm that subjects were consuming the assigned supplement and using the supporting materials as instructed. Clinical evaluations were conducted at visit 1 (baseline), visit 2 (week 4), and visit 3 (week 8). Subjects participated in the following procedures at each time point (unless otherwise indicated): • Clinical Grading of Efficacy Parameters Each subject was clinically graded for fine lines and wrinkles on the periocular area and global face; skin smoothness (visual) on the cheeks; and firmness (sagging) (visual), radiance, and overall appearance of skin condition (healthy) on the global face. Additionally, triplicate pinch recoil measurements were performed on the left crow’s feet area to assess skin elasticity/resiliency. • Digital Imaging Using Portrait Photo Station Full-face digital images were taken from each subject (left, center, and right views) using the SGS Stephens, Inc. portrait photo station with a Canon Mark II 7D digital SLR camera (Canon Incorporated, Tokyo, Japan) and a Canon EF-S 60mm f/2.8 macro lens under visible lighting mode. • Antera 3D Imaging Digital images were taken from each subject’s left or right cheek, as determined by the grader, using Antera 3D® imaging (Miravex Ltd, Dublin, Ireland). After study completion, images were analyzed for mean roughness (Ra). • Cutometer Measurements Duplicate measurements were taken from adjacent sites on each subject’s right under-eye orbital bone using Cutometer MPA 580 (Courage + Khazaka electronic GmbH, Köln, Germany) to measure the viscoelastic properties of the skin. • Self-assessment Questionnaire At week 8, subjects completed a Sponsor-provided self-assessment questionnaire regarding skin improvements and product perception. |
| Intervention type | Supplement |
| Primary outcome measure | The following primary outcome measures were assessed at clinical evaluations conducted at visit 1 (baseline), visit 2 (week 4), and visit 3 (week 8): 1. Clinical Grading of Efficacy Parameters: Each subject was clinically graded for fine lines and wrinkles on the periocular area and global face; skin smoothness (visual) on the cheeks; and firmness (sagging) (visual), radiance, and overall appearance of skin condition (healthy) on the global face. 2. Skin elasticity/resilience was measured using triplicate pinch recoil measurements performed on the left crow’s feet area |
| Secondary outcome measures | The following secondary outcome measures were assessed at clinical evaluations conducted at visit 1 (baseline), visit 2 (week 4), and visit 3 (week 8), unless stated: 1. Mean skin roughness was measured using the following digital images after study completion: 1.1. Full-face digital images captured using SGS Stephens, Inc. portrait photo station with a Canon Mark II 7D SLR camera and a Canon EF-S 60mm f/2.8 macro lens under visible lighting mode 1.2. Cheek images captured using Antera 3D® imaging system 2. Viscoelastic properties of adjacent skin sites on each subject’s right under-eye orbital bone the skin were measured using a Cutometer MPA 580 3. Skin improvements and product perception were measured using a Sponsor-provided self-assessment questionnaire at week 8 |
| Overall study start date | 19/05/2022 |
| Completion date | 22/08/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 45 Years |
| Upper age limit | 71 Years |
| Sex | Female |
| Target number of participants | 90 |
| Total final enrolment | 89 |
| Key inclusion criteria | Women |
| Key exclusion criteria | Women with limited fine lines and facial wrinkles |
| Date of first enrolment | 19/05/2022 |
| Date of final enrolment | 19/08/2022 |
Locations
Countries of recruitment
- United States of America
Study participating centre
1801 North Glenville Drive, Suite 20
Richardson
75081
United States of America
Sponsor information
Industry
8609 Westwood Center Drive #110
Tysons Corner
22182
United States of America
| Phone | +1 9048919746 |
|---|---|
| irina@specnova.com | |
| Website | https://specnova.com/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/11/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from Irina Lorenzi, irina@specnova.com. Informed consent was obtained. |
Editorial Notes
29/08/2025: Study's existence confirmed by the Advarra Institutional Review Board, USA.
