A Randomized, Double-Blind, Placebo-Controlled Study Evaluating a Novel Skin Care Cream with Olea europaea Stem Cell Extract Following Nd:YAG 1064 nm Laser Epilation
Abstract
:1. Introduction
2. Materials and Methods
2.1. Formulation
2.2. Quality Control of the Cosmetic Creams
2.2.1. Physicochemical Stability of Cosmetic Creams
Determination of Phenoxyethanol in the Cream with OLEA VITAE™ 02
Determination of Butylated Hydroxytoluene in the Cream with OLEA VITAE™ 02
2.2.2. Microbiological Control and Assessment of the Effectiveness of Preservation
2.3. Evaluation Methods
2.3.1. Biophysical Measurements
2.3.2. Skin Biopsies
Hematoxylin/Eosin Stain and Epidermis Depth Calculations
Masson Trichrome Stain and Quantification
2.3.3. Self-Assessment Questionnaire
- Self-assessment questionnaire completed by the enrolled volunteers
- Regarding the therapy
- Date
- Session number
- Product code number
- Regarding the volunteers
- 4.
- Sex (male/female/other)
- 5.
- Age
- 6.
- Body area to be treated
- 7.
- Is your hirsutism hormonally induced?
- 8.
- What is your hair type?
- 9.
- How would you characterize your skin?
- 10.
- Is this your first session of laser epilation? If not, in what area have you had laser before?
- Regarding the subjective evaluation of the cream applied after laser epilation
- 11.
- Did you notice your pain being relieved after being treated with the product?
- 12.
- Did you notice redness of the skin after being treated with the product?
- 13.
- Did you notice your skin healing faster after being treated with the product?
- 14.
- Did you notice the product has anti-inflammatory action?
- 15.
- Did you notice your skin is more hydrated after being treated with the product?
- 16.
- Did you notice an oily sensation after application of the product?
- 17.
- Did you notice the product reduces redness of the skin?
- 18.
- Did you feel an itching effect after application of the product?
2.3.4. Clinical Evaluation
2.3.5. Statistical Analysis of the Biophysical Measurements and Skin Biopsies
2.3.6. Statistical Analysis for the Self-Assessment Questionnaire
3. Results
3.1. Quality Control
3.2. Biophysical Measurements
3.2.1. Trans-Epidermal Water Loss (TEWL)
3.2.2. Keratin Hydration
3.2.3. Melanin Index (MI)
3.2.4. Erythema Index (EI)
Elasticity Index—R2
Elasticity Index—R5
Elasticity Index—R7
3.3. Analysis of Skin Biopsy Results
3.4. Analysis of Self-Assessment Questionnaire Results
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Phenoxyethanol | Butylated Hydroxytoluene | |
---|---|---|
Mobile phase | * Water/acetonitrile 70/30 | * A: Acetonitrile/B: acetic acid 0.04% in water, 90%SS/10% (v/v) |
Flow rate (mL/min) | 1.0 | 1.0 |
Infusion volume (μL) | 10 | 10 |
Chromatographic column | Discovery HS C18 250 × 4.6 mm, 5 μm | Discovery HS C18 250 × 4.6 mm, 5 μm |
Column temperature (o C) | 300 | 300 |
Detection (nm) | 270 | 280 |
Runtime (min) | 15 | 10 |
Retention time (Rt) (min) | 7.6 | 7.51 |
Evaluation Time | Qualitative and Quantitative Evaluations |
---|---|
D0 | Instrumental evaluation of TEWL, skin hydration, melanin index, erythema index, and skin elasticity before laser application Dermatological evaluation of basal skin condition Skin biopsy before laser application Application of laser epilation |
D14 | Instrumental evaluation of TEWL, skin hydration, melanin index, erythema index, and skin elasticity after 14 days of laser and product application Dermatological evaluation of basal skin condition Tolerability and adverse events Skin biopsy after 14 days of laser and product application Self-assessment questionnaire |
Physical–Chemical Parameters | Specifications /Limits | Method | 25 °C ± 1 °C 40% RH Release Date | 42 °C ± 1 °C 75% RH 3 Months | 50 °C ± 1 °C 75% RH 2 Months | 25 °C ± 1 °C 40% RH 12 Months |
---|---|---|---|---|---|---|
Aspect | White cream | Organoleptic | Conforms | Conforms | Conforms | Conforms |
Odor | Characteristic | Organoleptic | Conforms | Conforms | Conforms | Conforms |
pH (as is) | 4.80–5.20 | Potentiometry | 5.05 | 5.11 | 5.18 | 5.09 |
Viscosity (Brookfield DV-I+, spindle F, rpm 6, Θ: 20 °C) | 40,000–60,000 cPs | Viscometer | 42,000 cPs | 43,000 cPs | 41,500 cPs | 48,500 cPs |
Centrifugation (4.000 rpm, 1 h ) | Homogeneous | Centrifuge | Stable | Stable | Stable | Stable |
BHT | 0.09–0.11 % w/w | HPLC | 0.10 | 0.09 | 0.11 | 0.09 |
Phenoxyethanol | 0.81–0.99 % w/w | HPLC | 0.91 | 0.95 | 0.92 | 0.97 |
TEWL | |||
Groups | Time (Days) | Percentage Change D0–D14 (%) | |
D0 | D14 | ||
Placebo | 14.02 ± 6.63 | 16.64 ± 9.96 | 22.56 ± 43.50 |
OLEA | 13.10 ± 3.05 | 14.20 ± 7.45 | 4.28 ± 39.11 |
p-value | p = 0.762 | p = 0.641 | p = 0.462 |
Keratin Hydration | |||
Groups | Time (days) | Percentage change D0–D14 (%) | |
D0 | D14 | ||
Placebo | 43.97 ± 16,28 | 49.97 ± 13.18 * | 18.36 ± 18.14 |
OLEA | 45.79 ± 16,90 | 64.76 ± 23.39 ** | 42.02 ± 14.03 |
p-value | p = 0.853 | p = 0.207 | p = 0.030 |
Melanin Index | |||
Groups | Time (days) | Percentage change D0–D14 (%) | |
D0 | D14 | ||
Placebo | 147.67 ± 45.59 | 165.50 ± 49.00 * | 14.00 ± 20.69 |
OLEA | 136.00 ± 43.97 | 128.17 ± 43.29 | −5.82 ± 9.60 |
p-value | 0.660 | 0.192 | 0.059 |
Erythema Index | |||
Groups | Time (days) | Percentage change D0–D14 (%) | |
D0 | D14 | ||
Placebo | 270.83 ± 37.58 | 253.83 ± 38.63 | −5.54 ± 14.71 |
OLEA | 290.83 ± 27.73 | 235.50 ± 45.09 ** | −19.38 ± 10.21 |
p-value | p = 0.319 | p = 0.467 | p = 0.088 |
R2 | |||
Groups | Time (days) | Percentage change D0–D14 (%) | |
D0 | D14 | ||
Placebo | 0.71 ± 0.04 | 0.62 ± 0.08 | −11.44 ± 14.30 |
OLEA | 0.75 ± 0.11 | 0.82 ± 0.06 | 10.62 ± 16.59 |
p-value | p = 0.369 | p < 0.005 | p = 0.033 |
R5 | |||
Groups | Time (days) | Percentage change D0–D14 (%) | |
D0 | D14 | ||
Placebo | 0.68 ± 0.22 | 0.50 ± 0.18 * | −24.48 ± 23.48 |
OLEA | 0.73 ± 0.33 | 0.77 ± 0.32 | 10.00 ± 28.70 |
p-value | p = 0.748 | p = 0.103 | p = 0.046 |
R7 | |||
Groups | Time (days) | Percentage change D0–D14 (%) | |
D0 | D14 | ||
Placebo | 0.45 ± 0.10 | 0.36 ± 0.11 * | −18.63 ± 16.42 |
OLEA | 0.46 ± 0.20 | 0.53 ± 0.15 * | 24.51 ± 26.89 |
p-value | p = 0.884 | p = 0.043 | p = 0.010 |
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Gardiki, V.; Varvaresou, A.; Papageorgiou, S.; Protopapa, E.; Pavlou, P.; Rallis, E.; Papadopoulos, A.; Chaniotis, D. A Randomized, Double-Blind, Placebo-Controlled Study Evaluating a Novel Skin Care Cream with Olea europaea Stem Cell Extract Following Nd:YAG 1064 nm Laser Epilation. Cosmetics 2025, 12, 2. https://doi.org/10.3390/cosmetics12010002
Gardiki V, Varvaresou A, Papageorgiou S, Protopapa E, Pavlou P, Rallis E, Papadopoulos A, Chaniotis D. A Randomized, Double-Blind, Placebo-Controlled Study Evaluating a Novel Skin Care Cream with Olea europaea Stem Cell Extract Following Nd:YAG 1064 nm Laser Epilation. Cosmetics. 2025; 12(1):2. https://doi.org/10.3390/cosmetics12010002
Chicago/Turabian StyleGardiki, Vassiliki, Athanasia Varvaresou, Spyridon Papageorgiou, Evangelia Protopapa, Panagoula Pavlou, Efstathios Rallis, Apostolos Papadopoulos, and Dimitrios Chaniotis. 2025. "A Randomized, Double-Blind, Placebo-Controlled Study Evaluating a Novel Skin Care Cream with Olea europaea Stem Cell Extract Following Nd:YAG 1064 nm Laser Epilation" Cosmetics 12, no. 1: 2. https://doi.org/10.3390/cosmetics12010002
APA StyleGardiki, V., Varvaresou, A., Papageorgiou, S., Protopapa, E., Pavlou, P., Rallis, E., Papadopoulos, A., & Chaniotis, D. (2025). A Randomized, Double-Blind, Placebo-Controlled Study Evaluating a Novel Skin Care Cream with Olea europaea Stem Cell Extract Following Nd:YAG 1064 nm Laser Epilation. Cosmetics, 12(1), 2. https://doi.org/10.3390/cosmetics12010002