Evaluation of Efficacy of a Skin Care Regimen Containing Methyl Estradiolpropanoate (MEP) for Treating Estrogen Deficient Skin

December 2019 | Volume 18 | Issue 12 | Original Article | 1226 | Copyright © December 2019


Joel L. Cohen MD

AboutSkin Research LLC, Greenwood Village, CO

year and no more than 10 years were enrolled in the study. Each subject enrolled in the study had at least a Grade II in wrinkles and score of 5 (of 9) in elastosis on the Fitzpatrick-Goldman Clas- sification of Wrinkling and Degree of Elastosis Scale, a validated assessment tool used to measure wrinkling and degree of elastosis including laxity, dyschromia, erythema, and changes in texture. Each subject enrolled also measured with a score of 3 or greater on the Facial Skin Hydration Scale.

Exclusion criteria included patients who were either currently on hormone replacement therapy, or had ever been treated in the past with hormone replacement therapy, patients using any topical cosmetic anti-wrinkle and/or skin lightening products known to affect skin aging or products containing vitamin A de- rivatives on the face within 14 days prior to or during the study period. In addition, women using any topical imiquimod, 5-fluo- rouracil, or diclofenac on their face within 12 weeks prior to or during the study period were also excluded. Subjects receiving a chemical peel, or a non-ablative laser or light-based therapy on their face must have had discontinued the specific treatment at least 3 months prior to entering the study. Subjects receiving radiofrequency or ultrasound treatment on their face must have had discontinued the treatment at least 6 months prior to entering the study. Subjects receiving traditional dermabrasion (deep skin peel) such as diamond fraise, and/or ablative laser treatments on their face must have had discontinued the treat- ment at least 6 months prior to entering the study. Patients with a history of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters were also excluded. Other exclusion criteria were having current actinic keratoses or any skin cancer(s) in the treatment areas; significant history or current evidence of a medical, psychological or other disorder; prior history of cancer other than basal cell carcinoma (BCC); any active systemic disease that is not yet deemed medically stabilized; or an active bacterial, fungal, or viral infection.

Skin Care Regimen
Subjects were instructed at the baseline visit to apply one pump of the Emepelle Serum to face in the morning (immediately after cleansing and drying) and to apply a thin layer of Emepelle Night Cream to the entire face at night (immediately after cleansing and drying). Subjects were told to only use the skin care products provided and to wash their face twice daily with the provided gentle cleanser (CeraVe®). Each morning, subjects were required to apply the provided facial sunscreen SPF30 (CeraVe®) 15 minutes after applying the Emepelle Serum and to reapply the sunscreen every 2 hours throughout the day if exposed to direct sunlight.

Study restrictions included avoiding excessive exposure to sunlight or sunlamps in the treatment area and not applying any lotions, creams, powders, or solutions to the treated areas dur-ing the study period unless provided by their physician. Use of any topical products containing retinoids, hydroquinone, alpha- hydroxy acids, salicylic acid, and vitamins C or E on the face was also restricted for the duration of the study.

Follow up visits with photos were performed at 8 weeks, 14 weeks, and 20 weeks to evaluate efficacy.

Canfield Visia Complexion Analysis and standard photography were performed at baseline and at each of these follow up visits to capture ongoing and post-treatment status.

Quantitative Evaluations
Quantitative evaluations including validated Fitzpatrick-Gold- man Classification of Wrinkling and Degree of Elastosis Scale, Alexiades-Armenakas Comprehensive Grading Scale for As- sessment of Skin Aging and Photodamage, the Facial Skin Hydration Scale, a 0 to 5 scale where 0 = smooth and well-hy- drated skin and 5 = severely dry skin with moderate scaling and coarseness, and Clinician Global Aesthetic Improvement Score (C-GAIS), a 1 to 5 scale, with 1 meaning very much improved and 5 meaning worsened, were performed to assess improve- ment in facial aging. Subject Qualify of Life Questionnaire and Subject Improvement Score evaluations were used to assess tolerability.

Investigator Evaluations
Investigator performed evaluations included the Fitzpatrick- Goldman Classification of Wrinkling and Degree of Elastosis Scale (0-9 scale) at Visit 1, 2, 3, and 4. A score of 0-4 using the Alexiades-Armenakas Comprehensive Grading Scale for (1) Rhytides, (2) Dyschromia, (3) Erythema-Telangectasia, (4) Ker- atoses, and (5) Texture. For each category, a mean percent improvement was calculated on Visit 1, 2, 3, and 4. The Facial Skin Hydration was used for evaluation on Visit 1, 2, 3, and 4.The Clinician Global Aesthetic Improvement Score (C-GAIS) was completed on Visit 2, 3, and 4. The Investigator Tolerability and Side Effects Assessment was completed at all follow-up visits to evaluate any side-effects including erythema, edema, scaling, and itching (0 to 4 scale where 0 = none and 4 = severe).

Subject Evaluations
The Subject Global Aesthetic Improvement Score (S-GAIS) was completed on Visit 2, 3, and 4. The Subject Quality of Life Ques- tionnaire was completed by the patient on post-final treatment Visit 2, 3, and 4. The Subject Questionnaire on Quality of Skin Improvement was completed on treatment Visit 2, 3, and 4. The SubjectTolerability and Side Effects Assessment was completed at all follow-up visits (erythema, edema, scaling, and itching on a 0 to 4 scale where 0 = none and 4 = severe).

RESULTS

Fourteen subjects successfully completed the study.