Clinical Evaluation of a Topical Unani Polyherbal Formulation in the Management of Photodamaged Facial skin: An open-label Standard Controlled Trial.

INTRODUCTION: Ageing is a natural process of life. With increasing age, the skin suffers progressive morphological and physiological decrement. Hyperpigmentation, Wrinkles, and roughness of skin are some of the symptoms of aged skin. Exposure to sunlight, pollution, stress, nicotine, etc aggravates Skin aging. This study aimed to determine the efficacy and safety of polyherbal formulation and compare its efficacy with the standard drug tretinoin in subjects of moderate to advanced Photoaged facial skin. Ingredients of polyherbal formulation are Aarade baqla (Vicia faba), Jau (Hordeum vulgare), Nakhud (Cicer arietinum),Masoor (Lens esculenta), Tukhm e turb (Raphanus sativus), Khardal (Brassica nigra), Haldi (Curcuma longa), Kateera (Cochlospermum religiosum).

METHODS: This was a randomized open-label standard controlled study. 82 eligible subjects were allocated equally into test and control groups by computer-generated random numbers. In the test group, a paste of 15 gm polyherbal formulation in milk, and the control group, 0.025% Tretinoin 1 gram was used topically on the face once a day for two months. The response was assessed by theclinician using following different scales for different parameters.

ASSESSMENT OF SKIN HYPERPIGMENTATION: It was assessed by the Skin Hyperpigmentation Index online calculator (SHI). It describes the ratio of two scores, namely the hyperpigmented skin of the affected area and normal sun-protected skin from the same patient. The image was recorded with a Digital microscope-Win7 from a hyperpigmented area and normal sun-protected area. Both the images were uploaded on https://shi.skinimageanalysis.com/ and calculated the mean value of hyperpigmentation. SHI ranges from 1 (no hyperpigmentation) to 4 (maximum hyperpigmentation) where scores between 1 and 2 showed as light hyperpigmentation, 2-3 as medium hyperpigmentation, and scores between 3 and 4 as severe hyperpigmentation.

ASSESSMENT OF FINE WRINKLES: Fine wrinkles number was determined by digital photography. The photographs were taken through Canon EOS 1500D DSLR Camera with an 18-55 mm Lens. Three images were taken of each subject's face (right, left, and center full face) on Baseline and Day 15th, 30th, 45th, and 60th to assess visible changes/improvement in their fine wrinkles score.

ASSESSMENT OF NASOLABIAL FOLD: Modified Fitzpatrick Wrinkle Scale (MFWS) was used to assess Nasolabial folds. The scale comprised four main classes of Nasolabial wrinkling: 0, 1, 2, and 3 representing absent, fine, moderate, and deep wrinkles, respectively, and three inter classes i.e., 0.5, 1.5, and 2.5 to estimate wrinkle depth. The definitions of the entire classes of the scale are as follows: Class 0 = No wrinkle. No visible wrinkle; continuous skin line; Class 0.5 = Very shallow yet visible wrinkle; Class 1= Fine wrinkle. Visible wrinkle and slight indentation; Class 1.5= Visible wrinkle and clear indentation. <1-mm wrinkle depth; Class 2= Moderate wrinkle. Visible wrinkle, 1- to 2-mm wrinkle depth; Class 2.5= Prominent and visible wrinkle. More than 2-mm and less than 3-mm wrinkle depth; Class 3=Deep wrinkle. Deep and furrow wrinkle; more than 3-mm wrinkle depth.

ASSESSMENT OF FOREHEAD LINES SCORE: Forehead lines were assessed (number and depth) by a Validated Grading Scale for Forehead Lines. The Forehead Lines Grading Scale is a 5- point photonumeric rating scale that was developed to objectively quantify resting (static) and hyperkinetic (dynamic) forehead lines. The scale ratings are 0 for no wrinkles, 1 for no wrinkles present at rest but fine lines with facial expression, 2 for fine wrinkles present at rest and deep lines with facial expression, 3 for fine wrinkles present at rest and deeper lines with facial expression, and 4 for deeper wrinkles at rest and deeper furrows with facial expression.

ASSESSMENT OF LATERAL CANTHAL LINES: The number of lateral canthal lines was determined by a Validated Grading Scale for Crow's Feet. The Crow's Feet Grading Scale is a 5- point photonumeric rating scale developed to objectively quantify the severity of crow's feet. This scale was applied to two separate evaluations of crow's feet: at rest (static) and with expression (dynamic). The scale ratings are 0 for no wrinkles, 1 for very fine wrinkles, 2 for fine wrinkles, 3 for moderate wrinkles, and 4 for severe wrinkles.

ASSESSMENT OF FACIAL SKIN ROUGHNESS: The Allergan Skin Roughness Scale was used for facial skin roughness assessment. The area of assessment for the Allergan Skin roughness Scale is the area between the nasolabial fold to the preauricular cheek and from the inferior orbital rim to the mandible. The Allergan Skin Roughness Scale assigns a grade from none (0) to extreme (4) that describes the severity of skin coarseness, crosshatching, and elastosis in the midface area. The scale grading are 0 (None) Smooth visual skin texture, 1 (Minimal) Slightly coarse and uneven visual skin texture, 2 (Moderate) Moderately coarse and uneven visual skin texture; may have early elastosis, 3 (Severe) Severely coarse visual skin texture, cross-hatched fine lines; may have some elastosis, and 4 (Extreme) Extremely coarse visual skin texture, cross Hatched deep creases; extreme elastosis.

ASSESSMENT OF FACIAL DULLNESS: Dullness was assessed on a clinical basis with an arbitrary scoring ranging from 0 to 9 where 0-3=mild, 3.5-6=moderate, and 6.5-9=severe facial skin dullness.

ASSESSMENT OF QUALITY OF LIFE: Subjects' life quality was assessed by the Dermatology Life Quality Index questionnaire. It consists of 10 questions. Each question is scored on a four-point Likert scale: Very much = 3, A lot = 2, A little = 1, Not at all = 0, Not relevant = 0 and Question unanswered = 0. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. Where, 0-1= no effect at all on patient's life, 2-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11-20 = very large effect on patient's life, 21-30 = extremely large effect on patient's life.

RESULTS: Both groups showed a significant improvement in Fine Wrinkles, Forehead Lines, Crow's Feet, Roughness, Dullness, Nasolabial Fold, Hyperpigmentation, and Quality of Life parameters. (P < .001) A large number of subjects in the control group reported mild to moderate redness, itching, dryness, and blackening of the skin, while in the test group, absolutely no side effects were reported during treatment.

CONCLUSION: The effects in both groups were substantial, but the polyherbal formulation is safe and effective for use in photoaged facial skin. It may be a more feasible easily accessible cheap and safe formulation to prevent skin aging and restore skin elasticity and make skin brighter. Further studies to evaluate the efficacy of formulation on objective parameters using standard instruments should be done for appropriate measurements of parameters.